KOSO (Keep On Stepping On)/ Stepping Online

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT02774889
• Collaborator: (none)
• Enrollment: 45
• Arms: 2
• Actual Duration (Months): 21.9

Study Details

Study Description

Brief Summary

The overall purpose of this multi-phase study is to develop (Phase 1) and test potential effectiveness and feasibility of Keep On Stepping On (KOSO)/Stepping Online, an online falls prevention maintenance program for Stepping On (SO) graduates in a group randomized trial (Phase 2).

This application refers to effectiveness component of Phase 2, which entails the randomized clinical trial. Phase 1 has been completed. The feasibility component of Phase 2 will entail process evaluation of the Stepping Online intervention group only.

Condition or Disease	Intervention/Treatment	Phase
Fall Related Injury; Social Isolation	Behavioral: Stepping Online	N/A

Detailed Description

Aim:

This application, for Phase 2 of a larger study, is a 6-month group randomized trial to test the effectiveness of Stepping Online.

Stepping Online (developed in Phase 1) is a continuation website to help Stepping On graduates to:

1. Maintain exercises and fall prevention strategies learned in Stepping On, and

2. Stay connected with other participants and leaders/peer leaders in the 7-week workshop.

Approach:

1. Subject Eligibility:

2. Stepping On leaders and peer leaders of Milwaukee, Dane, Rock, Adams, Green Lake, Marquette and Waushara Counties during the enrollment window

3. Stepping On participants/graduates of the above workshops whose leader assesses that they can safely use Stepping Online to exercise at home

4. Recruitment and Consenting:

5. Leaders/Peer Leaders: County aging unit coordinators will invite leaders to participate in the study and share the names of those who agree with the study research staff. Staff will then explain the study in detail, answer questions, and obtain informed consent from those who agree.

6. Participants: (1) Research staff will visit participating leader/peer leader workshops to explain the study; (2) leader will distribute a card for participants to agree to a researcher phone call to learn more. They will then share the contact information of those who agree with study research staff; (3) study research staff members will contact and conduct a recruitment interview by phone. They then schedule those who agree to come to the site where the workshop occurred (or another public place that is private and convenient for research subjects) for consenting and baseline measurement.

7. Randomization

Randomization will occur on the Stepping On workshop level to ensure that leaders, peer leaders and participants are in the same arm. Procedures:

1. County liaisons, who routinely collect data, will provide participants' education level (without personal identifiers);

2. Study biostatistician pairs workshops based on above data, as well as geographic location and other data to ensure comparability.

3. Participants from each designated pair of SO workshops will provide informed consent and participate in baseline measurements

4. Designated pair of SO workshops will be randomized to the Stepping Online (intervention) or to the usual care Control arm.

5. Intervention arm: Stepping On graduates (and their leaders/peer leaders) will receive the Stepping Online website for 6 months. They can use their own computer or receive a laptop and Internet access (if needed) for the study duration. Research staff will provide 2 in-home training sessions (2 weeks apart) on how to use Stepping Online's fall prevention features (described under the "Arms and Intervention" section). Participants can call the technical support phone line for more help.

6. Control arm: Stepping On graduates in this arm will not receive Stepping Online.

7. Neither the intervention nor the control arm subjects will have access to Stepping Online after the 6-month trial.

8. Participants in both study arms will complete measurements at their workshop location or another location that is private and convenient fir subjects at baseline (prior to randomization), and later at 3 and 6 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Once 'Stepping On' Ends: Continuing a Group Falls Prevention Program Via the Internet
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stepping Online Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors. Fall prevention tips Fall prevention exercise videos noting technique and safety Guest expert videos and communication with expert Tools to set exercise goals, reminders and track progress Fall prevention specialist for feedback and group activities Discussion and messaging (1:1, small and large group) Fall prevention resources.	Behavioral: Stepping Online; Stepping Online is a password-protected website with Stepping On graduates, whose groups are randomized to Stepping Online and will have access to and training in a password-protected website. The website includes: Fall prevention tips Fall prevention exercise videos with narrations for proper technique and safety precautions Guest expert videos with online access to the guest expert to ask questions Tools to set exercise goals, get reminders and track progress Access to a fall prevention specialist for personal feedback and suggested group homework Group discussion and messaging (one-to-one and with their fellow Stepping On workshop participants group, or with all Stepping Online participants and leaders) Fall prevention resources; Other Names: Keep On Stepping On (KOSO)
No Intervention: Stepping On Usual Care Control Subjects control workshops in the condition will not have access to Stepping Online.

Outcome Measures

Primary Outcome Measures

1. Change of Number of Falls From Baseline to 6 Months [baseline and 6 months]

   Number of Falls: monthly calendar self-administered sent and returned via mail

Secondary Outcome Measures

1. Number of Tandem Walk Errors at 3 Months and 6 Months [up to 6 months]

   Observed via the Tandem Walk Test at baseline, 3 months, 6 months. Tandem walk errors were the number of errors while walking a four-meter straight line. Place a line on the floor marking the distance. The heel of one foot should be touching the tip of the toes of the other foot. Count the number of errors (stepping off the straight line, not putting heel to toe, needing to grab for support, significant body lean). Participants can use an assistive device if they normally use one.

2. Gait Speed at 3 Months and 6 Months [up to 6 months]

   Observed at baseline, 3 months, 6 months; measured in meters per second over four meters.

3. Short Physical Performance Battery (SPPB): Total Balance Test [up to 6 months]

   Standing feet together (side by side) for 10 seconds, followed by standing with side of one heel touching the big toe of the other foot (semi-tandem) for 10 seconds, followed by standing with the heel of one foot in front of the toes of the other (tandem) for 10 seconds. Participants are scored either 0 or 1 for each balance exercise with a total possible range from 0-3 where higher scores indicate improved balance.

4. Short Physical Performance Battery (SPPB): Gait Speed Test [6 months]

   Participant is timed while walking an 8 foot line on the floor. Scoring is as follows: 0 = could not do = >5.7 sec (<0.43 m/sec) = 4.1-6.5 sec (0.44-0.60 m/sec) = 3.2-4.0 (0.61-0.77 m/sec) = <3.1 sec (>0.78 m/sec)

5. Short Physical Performance Battery (SPPB): Chair Stand Test [up to 6 months]

   Participant is timed while attempting to stand up and sit down 5 times from a chair without using their arms. Scoring is as follows: 0 = unable = > 16.7 sec = 16.6-13.7 sec = 13.6-11.2 sec = < 11.1 sec

6. Short Physical Performance Battery (SPPB): Summary Score [up to 6 months]

   The total possible range of scores for the SPPB repeated chair test, gait test, and balance test is 0-12 where higher scores indicate the best performance.

7. Falls Behavioral Risk Scale (FaB) [up to 6 months]

   The Falls Behavioral Scale is a list of 24 statements that describe things participants do in everyday life. Participants are to circle 'never', 'sometimes', 'often', 'always' or 'doesn't apply'. Scoring is from 1 (never) to 4 (always) and is reported as the average score where higher scores indicate higher mitigation of fall risk.

8. Revised UCLA Loneliness Scale (R-UCLA) [up to 6 months]

   A 3-item scale (adapted, short form of the full 20-item scale) designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. A 3-point Likert scale is used that ask participants to rate each item as either 3 - "I often feel this way", 2 - "I sometimes feel this way", or 1 - "I hardly ever feel this way". Scoring: Items 1-3 are summed and participants are given a composite score of 3-9, with higher scores indicating a greater sense of loneliness.

9. T-Score for Quality of Life Measured by PROMIS Global Mental Health (GMH) Instrument [up to 6 months]

   The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life Short Form is a 10-item instrument that measures both Physical (GPH) and Mental (GMH) Health. Each scale is reported as a T-score. The total possible range of scores for GMH is 21.2 - 67.6 where higher scores indicate better quality of life.

10. T-Score for Quality of Life Measured by PROMIS Global Physical Health (GPH) Instrument [up to 6 months]

    The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life Short Form is a 10-item instrument that measures both Physical (GPH) and Mental (GMH) Health. Each scale is reported as a T-score. The total possible range of scores for GPH is 16.2 - 67.7 where higher scores indicate better quality of life.

11. Physical Activity Barriers Self-Efficacy Score [up to 6 months]

    Self-efficacy to reduce barriers to exercise was measured using a 16-item survey where participants rate their confidence that they could perform falls prevention exercises every day for the next 3 months under various circumstances, from 0% 'not at all confident' to 100% 'very confident'. Scores will be reported from 0-10 with higher scores indicated increased self-efficacy.

12. Global Rating of Change Score at 6 Months [6 months]

    Measures self-perceived change in balance, quantifying the extent to which a participant's balance has improved or deteriorated in the over time (past 6 months). A single question asks the participant to rate their change in balance inside their house, and a single question asks patients to rate their change in balance outside of their house. A Likert scare of -7 ("a very great deal worse") to +7 ("a very great deal better") is used to rate this perceived change.

13. Balance Exercise Adherence at 3 and 6 Months [up to 6 months]

    Adherence was assessed at 3 and 6 months as the number of days balance exercises were performed each week.

14. Strength Exercise Adherence at 3 and 6 Months [up to 6 months]

    Adherence was assessed at 3 and 6 months as the number of days strength exercises were performed each week.

15. Social Bonding Score at 3 Months and 6 Months [up to 6 months]

    Socialization included the 5-item Social Bonding Scale at all timepoints measured as the summed score on a Likert scale of 0 (not at all) to 4 (very much), range 0-20.

16. Encouragement to do Exercises Score at 3 Months and 6 Months [up to 6 months]

    Socialization included the feeling Encouraged to Exercise at 3 and 6 months on 1 (very difficult) to 5 (very easy) scale.

17. Activities Balance Confidence (ABC) Scale at 3 and 6 Months [up to 6 months]

    The ABC instrument measures the confidence of participants from 0% (no confidence) to 100% (completely confident) for activity in a range of conditions. Scoring is from 0-10 where higher numbers are more confidence.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

List of Inclusion Criteria:

1. Leader/Peer Leader: Leading a SO workshop in Dane, Milwaukee, Rock, Adams, Green Lake, Marquette or Waushara counties during the timeframe prior to the 6-month trial.

2. Stepping On Participants/Graduates: Enrolled in one of the above SO workshops.

In Milwaukee and Dane counties, extra effort will be made to enroll African American Stepping On participants/graduates, who are more likely to have lower income and educational level and to be uninsured than their White counterparts.

List of Exclusion Criteria:

1. Leaders/Peer Leaders:

2. Not available to participate in Stepping Online for more than 4 weeks out of the 6 months following enrollment

3. Not in the area at the end of the 6-month trial.

4. Stepping On Participants/Graduates:

5. Unable participate in Stepping Online for more than 4 weeks out of the 6 months following enrollment

6. Not assessed to be safe by SO leader to do the online exercise program; not in the area for the 3 month and 6 month evaluations

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Principal Investigator: Jane E Mahoney, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 11, 2016

More Information

Publications

• Clemson L, Cumming RG, Kendig H, Swann M, Heard R, Taylor K. The effectiveness of a community-based program for reducing the incidence of falls in the elderly: a randomized trial. J Am Geriatr Soc. 2004 Sep;52(9):1487-94.
• Clemson L, Fiatarone Singh MA, Bundy A, Cumming RG, Manollaras K, O'Loughlin P, Black D. Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial. BMJ. 2012 Aug 7;345:e4547. doi: 10.1136/bmj.e4547.
• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94.
• Gustafson DH, Hawkins R, McTavish F, Pingree S, Chen WC, Volrathongchai K, Stengle W, Stewart JA, Serlin RC. Internet-Based Interactive Support for Cancer Patients: Are Integrated Systems Better? J Commun. 2008 Jun;58(2):238-257.
• Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
• Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672.
• Mahoney, J. E., Gangnon, R., Clemson, L. M., Gobel, V. L., & Lecey, V. (2012, November). Evaluation of stepping on implementation across Wisconsin. In GERONTOLOGIST (Vol. 52, pp. 479-479). JOURNALS DEPT, 2001 EVANS RD, CARY, NC 27513 USA: OXFORD UNIV PRESS INC.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT02774889
• Other Study ID Numbers: 2014-0125; A534255; SMPH/MEDICINE/GER-AD DEV
• First Posted: May 17, 2016
• Last Update Posted: Jan 31, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Wisconsin, Madison: Falls Prevention; Stepping On; Health Promotion; Implementation; Health Maintenance

Study Results

Participant Flow

Pre-assignment Detail	Of the total 157 invitees, 45 enrolled; 112 did not. Of the 112 non-joiners, 53 declined further contact; 16 were not reached; 12 were ineligible, 31 refused.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.The website includes: Fall prevention tips Fall prevention exercise videos with narrations for proper technique and safety precautions Guest expert videos with online access to the guest expert to ask questions Tools to set exercise goals, reminders and track progress Fall prevention specialist for feedback and group activities Discussion and messaging (1:1, small and large group) Fall prevention resources.	Control Stepping On graduates did not have access to Stepping Online.
Period Title: Overall Study
STARTED	23	22
COMPLETED	21	21
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Stepping Online	Stepping On 'Usual Care'	Total
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.	Total of all reporting groups
Overall Participants	23	22	45
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 21.7%	3 13.6%	8 17.8%
>=65 years	18 78.3%	19 86.4%	37 82.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.3 (9.04)	76 (7.35)	73.6 (8.50)
Sex: Female, Male (Count of Participants)
Female	21 91.3%	18 81.8%	39 86.7%
Male	2 8.7%	4 18.2%	6 13.3%
Race/Ethnicity, Customized (Count of Participants)
White, Non-Hispanic	18 78.3%	21 95.5%	39 86.7%
White, Hispanic	1 4.3%	0 0%	1 2.2%
African-American	4 17.4%	1 4.5%	5 11.1%
Region of Enrollment (participants) [Number]
United States	23 100%	22 100%	45 100%
Days Since Last Stepping On Class (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	35.9 (6.07)	37.4 (14.75)	36.31 (11.37)
Number of Falls in the Past 6 months (falls) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [falls]	0.45 (1.12)	0.50 (0.80)	0.47 (0.97)
Number of Participants Who Fell At Least 1 in the last 6 months (Count of Participants)
Count of Participants [Participants]	6 26.1%	7 31.8%	13 28.9%
Number of Participants With College Education (Count of Participants)
Count of Participants [Participants]	19 82.6%	16 72.7%	35 77.8%
Number of Married Participants (Count of Participants)
Count of Participants [Participants]	14 60.9%	4 18.2%	18 40%
Number of Participants in a City/Suburb (Count of Participants)
Count of Participants [Participants]	18 78.3%	13 59.1%	31 68.9%

Outcome Measures

1. Primary Outcome

Title	Change of Number of Falls From Baseline to 6 Months
Description	Number of Falls: monthly calendar self-administered sent and returned via mail
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepping Online	Stepping On 'Usual Care'
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	21	21
Mean (Standard Deviation) [falls]	0.28 (0.01)	0.40 (0.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.55
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Rate Ratio
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.27 to 2.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Tandem Walk Errors at 3 Months and 6 Months
Description	Observed via the Tandem Walk Test at baseline, 3 months, 6 months. Tandem walk errors were the number of errors while walking a four-meter straight line. Place a line on the floor marking the distance. The heel of one foot should be touching the tip of the toes of the other foot. Count the number of errors (stepping off the straight line, not putting heel to toe, needing to grab for support, significant body lean). Participants can use an assistive device if they normally use one.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On 'Usual Care'
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
Baseline (measured pre-randomization)	4.55 (3.85)	2.62 (2.80)
3 Months	2.10 (3.35)	6.84 (3.76)
6 Months	2.41 (3.11)	6.48 (4.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	at 3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.74
	Confidence Interval	(2-Sided) 95%; -6.61 to -2.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	at 6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.07
	Confidence Interval	(2-Sided) 95%; -6.47 to -1.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Gait Speed at 3 Months and 6 Months
Description	Observed at baseline, 3 months, 6 months; measured in meters per second over four meters.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On 'Usual Care'
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
Baseline (measured pre-randomization)	0.79 (0.25)	0.83 (0.24)
3 Months	0.87 (0.28)	0.79 (0.21)
6 Months	0.89 (0.24)	0.75 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95%; 0.00 to 0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95%; 0.07 to 0.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Short Physical Performance Battery (SPPB): Total Balance Test
Description	Standing feet together (side by side) for 10 seconds, followed by standing with side of one heel touching the big toe of the other foot (semi-tandem) for 10 seconds, followed by standing with the heel of one foot in front of the toes of the other (tandem) for 10 seconds. Participants are scored either 0 or 1 for each balance exercise with a total possible range from 0-3 where higher scores indicate improved balance.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Subjects control workshops in the condition will not have access to Stepping Online.
Measure Participants	23	22
baseline (measured pre-randomization)	2.65 (0.65)	2.32 (0.78)
3 months	2.60 (0.70)	2.57 (0.75)
6 months	2.59 (0.73)	2.64 (0.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; -0.40 to 0.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 95%; -0.48 to 0.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Short Physical Performance Battery (SPPB): Gait Speed Test
Description	Participant is timed while walking an 8 foot line on the floor. Scoring is as follows: 0 = could not do = >5.7 sec (<0.43 m/sec) = 4.1-6.5 sec (0.44-0.60 m/sec) = 3.2-4.0 (0.61-0.77 m/sec) = <3.1 sec (>0.78 m/sec)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Subjects control workshops in the condition will not have access to Stepping Online.
Measure Participants	23	22
baseline (measure pre-randomization)	3.09 (1.04)	3.18 (0.85)
3 months	3.25 (1.00)	3.07 (0.79)
6 months	3.46 (1.02)	3.12 (0.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.36
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.17
	Confidence Interval	(2-Sided) 95%; -0.20 to 0.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 95%; -0.11 to 0.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Short Physical Performance Battery (SPPB): Chair Stand Test
Description	Participant is timed while attempting to stand up and sit down 5 times from a chair without using their arms. Scoring is as follows: 0 = unable = > 16.7 sec = 16.6-13.7 sec = 13.6-11.2 sec = < 11.1 sec
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Subjects control workshops in the condition will not have access to Stepping Online.
Measure Participants	23	22
baseline (measure pre-randomization)	2.26 (1.21)	2.41 (1.10)
3 months	2.14 (1.50)	1.93 (1.18)
6 months	2.51 (1.47)	2.24 (1.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; -0.43 to 0.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.36
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.27
	Confidence Interval	(2-Sided) 95%; -0.31 to 0.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Short Physical Performance Battery (SPPB): Summary Score
Description	The total possible range of scores for the SPPB repeated chair test, gait test, and balance test is 0-12 where higher scores indicate the best performance.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Subjects control workshops in the condition will not have access to Stepping Online.
Measure Participants	23	21
baseline (measured pre-randomization)	8.00 (2.30)	7.91 (1.85)
3 months	7.97 (2.59)	7.58 (2.18)
6 months	8.55 (2.58)	8.01 (2.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 95%; -0.58 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95%; -0.42 to 1.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Falls Behavioral Risk Scale (FaB)
Description	The Falls Behavioral Scale is a list of 24 statements that describe things participants do in everyday life. Participants are to circle 'never', 'sometimes', 'often', 'always' or 'doesn't apply'. Scoring is from 1 (never) to 4 (always) and is reported as the average score where higher scores indicate higher mitigation of fall risk.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
baseline (measured pre-randomization)	2.73 (0.32)	2.62 (0.28)
3 month	2.93 (0.74)	2.68 (0.30)
6 month	2.72 (0.31)	2.92 (0.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 95%; -0.09 to 0.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.55 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Revised UCLA Loneliness Scale (R-UCLA)
Description	A 3-item scale (adapted, short form of the full 20-item scale) designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. A 3-point Likert scale is used that ask participants to rate each item as either 3 - "I often feel this way", 2 - "I sometimes feel this way", or 1 - "I hardly ever feel this way". Scoring: Items 1-3 are summed and participants are given a composite score of 3-9, with higher scores indicating a greater sense of loneliness.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
baseline (measured pre-randomization)	4.30 (1.49)	4.48 (1.66)
3 Months	4.28 (1.68)	4.37 (1.72)
6 Months	4.30 (1.92)	4.11 (1.48)

10. Secondary Outcome

Title	T-Score for Quality of Life Measured by PROMIS Global Mental Health (GMH) Instrument
Description	The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life Short Form is a 10-item instrument that measures both Physical (GPH) and Mental (GMH) Health. Each scale is reported as a T-score. The total possible range of scores for GMH is 21.2 - 67.6 where higher scores indicate better quality of life.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
baseline (measured pre-randomization)	46.89 (5.04)	47.58 (4.13)
3 months	47.12 (5.43)	47.26 (4.55)
6 months	46.61 (5.89)	46.94 (5.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 95%; -2.66 to 2.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95%; -2.79 to 2.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	T-Score for Quality of Life Measured by PROMIS Global Physical Health (GPH) Instrument
Description	The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life Short Form is a 10-item instrument that measures both Physical (GPH) and Mental (GMH) Health. Each scale is reported as a T-score. The total possible range of scores for GPH is 16.2 - 67.7 where higher scores indicate better quality of life.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
baseline (measured pre-randomization)	42.41 (5.84)	43.31 (4.66)
3 months	43.40 (5.60)	42.77 (4.77)
6 months	43.95 (4.54)	42.76 (5.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95%; -1.44 to 2.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; -1.49 to 3.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Physical Activity Barriers Self-Efficacy Score
Description	Self-efficacy to reduce barriers to exercise was measured using a 16-item survey where participants rate their confidence that they could perform falls prevention exercises every day for the next 3 months under various circumstances, from 0% 'not at all confident' to 100% 'very confident'. Scores will be reported from 0-10 with higher scores indicated increased self-efficacy.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
baseline (measured pre-randomization)	6.66 (2.53)	6.43 (1.28)
3 months	5.33 (2.08)	5.38 (2.44)
6 months	5.47 (2.37)	5.57 (2.03)

13. Secondary Outcome

Title	Global Rating of Change Score at 6 Months
Description	Measures self-perceived change in balance, quantifying the extent to which a participant's balance has improved or deteriorated in the over time (past 6 months). A single question asks the participant to rate their change in balance inside their house, and a single question asks patients to rate their change in balance outside of their house. A Likert scare of -7 ("a very great deal worse") to +7 ("a very great deal better") is used to rate this perceived change.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
Inside Balance	4.29 (2.63)	2.40 (3.20)
Outside Balance	4.05 (2.46)	2.30 (3.16)
Strength	3.76 (2.93)	1.90 (3.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	Inside Balance
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.89
	Confidence Interval	(2-Sided) 95%; 0.06 to 3.71
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	Outside Balance
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.75
	Confidence Interval	(2-Sided) 95%; -0.02 to 3.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	Strength
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.86
	Confidence Interval	(2-Sided) 95%; -0.08 to 3.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Balance Exercise Adherence at 3 and 6 Months
Description	Adherence was assessed at 3 and 6 months as the number of days balance exercises were performed each week.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
Balance Exercises at 3 Months	4.15 (1.58)	2.53 (2.08)
Balance Exercises at 6 Months	2.91 (2.23)	1.90 (1.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online
	Comments	Balance Exercises at 3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.63
	Confidence Interval	(2-Sided) 95%; 0.54 to 2.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	Balance Exercises at 6 Months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.01
	Confidence Interval	(2-Sided) 95%; -0.22 to 2.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Strength Exercise Adherence at 3 and 6 Months
Description	Adherence was assessed at 3 and 6 months as the number of days strength exercises were performed each week.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
3 Months	3.17 (1.43)	2.11 (1.45)
6 Months	2.40 (1.64)	1.64 (1.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	Strength Exercises at 3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.23 to 1.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	Strength Exercises at 6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; -0.16 to 1.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Social Bonding Score at 3 Months and 6 Months
Description	Socialization included the 5-item Social Bonding Scale at all timepoints measured as the summed score on a Likert scale of 0 (not at all) to 4 (very much), range 0-20.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
baseline (pre-randomization)	12.83 (3.51)	12.57 (4.03)
3 months	14.07 (4.69)	13.05 (4.51)
6 months	13.52 (3.97)	10.92 (4.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; -1.30 to 3.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.60
	Confidence Interval	(2-Sided) 95%; 0.43 to 4.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Encouragement to do Exercises Score at 3 Months and 6 Months
Description	Socialization included the feeling Encouraged to Exercise at 3 and 6 months on 1 (very difficult) to 5 (very easy) scale.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study.

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
3 months	3.61 (1.12)	3.29 (1.06)
6 months	3.34 (1.16)	2.72 (0.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.33
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95%; -0.33 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95%; -0.02 to 1.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Activities Balance Confidence (ABC) Scale at 3 and 6 Months
Description	The ABC instrument measures the confidence of participants from 0% (no confidence) to 100% (completely confident) for activity in a range of conditions. Scoring is from 0-10 where higher numbers are more confidence.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Not all participants completed the study

Arm/Group Title	Stepping Online	Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.	Control Stepping On graduates did not have access to Stepping Online.
Measure Participants	23	22
baseline (measured pre-randomization)	7.44 (1.67)	7.63 (1.42)
3 months	7.76 (1.59)	7.13 (1.46)
6 months	7.65 (1.56)	7.48 (4.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95%; -0.03 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stepping Online, Stepping On 'Usual Care'
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.59
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95%; -0.45 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	up to 6 months
Arm/Group Title	Stepping Online		Stepping On Usual Care Control
Arm/Group Description	Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.The website includes: Fall prevention tips Fall prevention exercise videos with narrations for proper technique and safety precautions Guest expert videos with online access to the guest expert to ask questions Tools to set exercise goals, reminders and track progress Fall prevention specialist for feedback and group activities Discussion and messaging (1:1, small and large group) Fall prevention resources.		Control Stepping On graduates did not have access to Stepping Online.
All Cause Mortality
	Stepping Online		Stepping On Usual Care Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)
Serious Adverse Events
	Stepping Online		Stepping On Usual Care Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Stepping Online		Stepping On Usual Care Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)

Limitations/Caveats

Limitations include the small sample size. With multiple tests/measures significance might have been by chance. Bonferroni corrections were not performed. Fewer than 30% of the SO graduates who were invited enrolled in the study; these results may not be generalizable to all SO graduates. Lack of access to and comfort with online devices were barriers for some refusers.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.