Tracking Physical Activity for Chronic Pain Management Among Older Adults in Detroit

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03285958
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief Summary

Wearable, commercially-available physical activity monitors are being increasingly incorporated into chronic pain self-management interventions as a tool to help patients set goals and to tailor intervention content based on patient progress. Yet older adults from resource-challenged communities may face significant barriers to using these monitors and reporting activity data. Our pilot study will focus on wearable monitor use among older adults in Detroit with chronic musculoskeletal pain, testing the feasibility and validity of various technology-based strategies for reporting daily step count data. The study will also assess whether six weeks of monitor use is associated with improvements in functioning, relative to a control group.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: STEPS Intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Promoting Physical Activity for Chronic Pain Management Among Older Adults in Detroit: Comparing Technology-Based Strategies
• Actual Study Start Date: Nov 16, 2017
• Actual Primary Completion Date: Jul 20, 2018
• Actual Study Completion Date: Aug 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STEPS Intervention Group Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period.	Behavioral: STEPS Intervention; Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.
No Intervention: STEPS Control Group Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.

Outcome Measures

Primary Outcome Measures

1. Change in Pain Interference [Baseline, eight weeks]

   The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference 4-item subscale, where a higher score indicates more pain interference. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much). Raw scores are converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation). The possible range is 42 to 76, with a higher score representing worse outcome.

2. Adherence to Step Count Reporting - SMS [Two weeks]

   Proportion of days that step count was successfully provided/possible reporting days for SMS

3. Adherence to Step Count Reporting - IVR [two weeks]

   Proportion of days that step count was successfully provided/possible reporting days for IVR.

4. Adherence to Step Count Reporting - Sync [two weeks]

   Proportion of days that step count was successfully provided/possible reporting days for syncing with app

Secondary Outcome Measures

1. Change in Physical Functioning [Baseline, eight weeks]

   The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome.

2. Change in Social Participation [Baseline, eight weeks]

   Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome.

3. Validity of Manually-reported Step Count Data - SMS [Two weeks]

   Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other

4. Validity of Manually Reported Step Count Data - IVR [Two weeks]

   Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 60 years

• Ambulatory with or without assistive device

• Community living

• Have a SMS-capable cell phone

• Internet access (via smartphone, in-home or elsewhere);

• Self-reported chronic musculoskeletal pain (pain in muscles or joints for > 3 months)

• 4 (0-10 scale) average pain level over last week

• 1 day/previous 30 when pain made it difficult to do usual activities

• Ability to travel to study location in Detroit for a one-time session

Exclusion criteria:

• Serious acute illness or hospitalization in last month

• Planned surgery in next month

• Severe cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Mary Janevic, University of Michigan School of Public Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2018
• Informed Consent Form - Jun 19, 2018

More Information

Publications

None provided.

• Responsible Party: Mary Janevic, Assistant Research Scientist, University of Michigan
• ClinicalTrials.gov Identifier: NCT03285958
• Other Study ID Numbers: HUM00133021
• First Posted: Sep 18, 2017
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• 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
• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Pre-assignment Detail	No significant pre-assignment events.

Arm/Group Title	STEPS Intervention Group	STEPS Control Group
Arm/Group Description	Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Period Title: Overall Study
STARTED	33	24
COMPLETED	28	23
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	STEPS Intervention Group	STEPS Control Group	Total
Arm/Group Description	Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.	Total of all reporting groups
Overall Participants	28	23	51
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.3 (7.1)	69.3 (6.4)	70.4 (6.8)
Sex: Female, Male (Count of Participants)
Female	26 92.9%	19 82.6%	45 88.2%
Male	2 7.1%	4 17.4%	6 11.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	27 96.4%	21 91.3%	48 94.1%
White	0 0%	0 0%	0 0%
More than one race	1 3.6%	1 4.3%	2 3.9%
Unknown or Not Reported	0 0%	1 4.3%	1 2%
Region of Enrollment (participants) [Number]
United States	28 100%	23 100%	51 100%
Pain intensity in last week (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.1 (1.3)	5.4 (2.2)	5.2 (1.8)
PROMIS 4-item pain interference T-score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	58.7 (6.1)	57.0 (8.4)	58.0 (7.2)
PROMIS 4-item physical function difficulty T-score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	33.2 (4.3)	31.9 (4.2)	33.0 (5.2)
PROMIS 4-item social partcipation T-score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	38.1 (7.3)	37.0 (6.4)	37.6 (6.9)

Outcome Measures

1. Primary Outcome

Title	Change in Pain Interference
Description	The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference 4-item subscale, where a higher score indicates more pain interference. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much). Raw scores are converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation). The possible range is 42 to 76, with a higher score representing worse outcome.
Time Frame	Baseline, eight weeks

Outcome Measure Data

Analysis Population Description

This is from the analytic sample that had both baseline and follow-up data on this measure. Change score is the follow-up minus baseline score, such that a greater, negative change value is a better outcome.

Arm/Group Title	STEPS Intervention Group	STEPS Control Group
Arm/Group Description	Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Measure Participants	28	23
Mean (Standard Deviation) [score on a scale]	-0.85 (6.2)	-0.21 (6.6)

2. Primary Outcome

Title	Adherence to Step Count Reporting - SMS
Description	Proportion of days that step count was successfully provided/possible reporting days for SMS
Time Frame	Two weeks

Outcome Measure Data

Analysis Population Description

Intervention group participants with baseline and follow-up data. Excludes one case that did not have a texting plan on her phone. Result represents number of adherent person-days out of all possible person-days for SMS.

Arm/Group Title	STEPS Intervention Group
Arm/Group Description	This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.
Measure Participants	27
Measure person-days	378
Count of Units [person-days]	299

3. Primary Outcome

Title	Adherence to Step Count Reporting - IVR
Description	Proportion of days that step count was successfully provided/possible reporting days for IVR.
Time Frame	two weeks

Outcome Measure Data

Analysis Population Description

Intervention group participants with baseline and follow-up data. Excludes one case who did not receive IVR calls on schedule due to system error. Result represents number of adherent person-days out of all possible person-days for IVR.

Arm/Group Title	STEPS Intervention Group
Arm/Group Description	This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.
Measure Participants	27
Measure person-days	378
Count of Units [person-days]	257

4. Primary Outcome

Title	Adherence to Step Count Reporting - Sync
Description	Proportion of days that step count was successfully provided/possible reporting days for syncing with app
Time Frame	two weeks

Outcome Measure Data

Analysis Population Description

Intervention group participants with baseline and follow-up data. Result represents number of adherent person-days out of all possible person-days for sync.

Arm/Group Title	STEPS Intervention Group
Arm/Group Description	This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.
Measure Participants	28
Measure person-days	392
Count of Units [person-days]	267

5. Secondary Outcome

Title	Change in Physical Functioning
Description	The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome.
Time Frame	Baseline, eight weeks

Outcome Measure Data

Analysis Population Description

Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value is a better outcome.

Arm/Group Title	STEPS Intervention Group	STEPS Control Group
Arm/Group Description	Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Measure Participants	28	23
Mean (Standard Deviation) [units on a scale (T-score)]	-1.4 (3.5)	-0.85 (3.7)

6. Secondary Outcome

Title	Change in Social Participation
Description	Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome.
Time Frame	Baseline, eight weeks

Outcome Measure Data

Analysis Population Description

Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value (or smaller positive value) is a better outcome.

Arm/Group Title	STEPS Intervention Group	STEPS Control Group
Arm/Group Description	Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.	Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
Measure Participants	28	23
Mean (Standard Deviation) [units on a scale]	0.28 (7.8)	0.83 (8.4)

7. Secondary Outcome

Title	Validity of Manually-reported Step Count Data - SMS
Description	Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other
Time Frame	Two weeks

Outcome Measure Data

Analysis Population Description

Result is number of person- days with valid data reported that were within 50 steps of sync value.

Arm/Group Title	STEPS Intervention Group
Arm/Group Description	This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.
Measure Participants	27
Measure person-days	256
Count of Units [person-days]	133

8. Secondary Outcome

Title	Validity of Manually Reported Step Count Data - IVR
Description	Correlation of manually-reported SMS data with automatically uploaded data - percentage of days that counts are within 50 steps of each other
Time Frame	Two weeks

Outcome Measure Data

Analysis Population Description

Result is number of person- days with valid data reported that were within 50 steps of sync value.

Arm/Group Title	STEPS Intervention Group
Arm/Group Description	This analysis was only conducted on the Intervention group, who participated in 6 weeks of tracking and reporting step counts.
Measure Participants	27
Measure person-days	215
Count of Units [person-days]	94

Adverse Events

Time Frame	8 weeks
Arm/Group Title	STEPS Intervention Group		STEPS Control Group
Arm/Group Description	Participants will receive a wearable physical activity monitor and will be asked to report their daily step count in 3 different ways (2 weeks each of SMS text messages, Interactive Voice Response calls (IVR), automatic upload) during the 6-week study period. STEPS Intervention: Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.		Participants in this group will not receive a wearable physical activity monitor and will not be asked to report their step count.
All Cause Mortality
	STEPS Intervention Group		STEPS Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/23 (0%)
Serious Adverse Events
	STEPS Intervention Group		STEPS Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/28 (3.6%)		0/23 (0%)
Respiratory, thoracic and mediastinal disorders
hospitalization	1/28 (3.6%)	1	0/23 (0%)	0
Other (Not Including Serious) Adverse Events
	STEPS Intervention Group		STEPS Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

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.