Stepping up to Health - for Veterans With Chronic Obstructive Pulmonary Disease (COPD)

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01102777
• Collaborator: (none)
• Enrollment: 307
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 12.3

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy of an internet-mediated pedometer based intervention that is designed to increase walking and improve function among veterans with chronic obstructive pulmonary disease (COPD). The Specific Aims are: 1) to test the effectiveness of an automated internet-mediated walking program for veterans with COPD with a primary outcome of improvement in health-related quality of life at four-months and at one year in a randomized controlled trial (RCT) with a wait list control. 2) to estimate the effect of internet-mediated walking program for veterans with COPD on all cause days of hospitalization over one year following randomization. 3) to compare intervention reach, participation and satisfaction outcomes between rural and urban veterans among those randomized to the intervention arm. The long-term objective of this research is to develop, evaluate and disseminate effective, low-cost interventions that improve quality of life for veterans, particularly rural veterans, managing complex chronic conditions.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Behavioral: automated internet-mediated walking program; Other: Usual Care	N/A

Detailed Description

Background:

Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Individuals with COPD who undergo a facility-based, exercise-focused pulmonary rehabilitation program experience significant improvements in health related quality of life, dyspnea, and exercise tolerance as well as reduced rates of hospitalization. Unfortunately, only a small percent of individuals with COPD who could benefit from pulmonary rehabilitation have access to and participate in such programs. Moreover, the benefits of short-term pulmonary rehabilitation programs tend to diminish rapidly after the program ends. Rural veterans are less likely to have access to facility-based pulmonary rehabilitation than urban veterans. Health related quality of life in rural veterans with COPD is significantly worse than for veterans with COPD who live in urban areas.

Objectives:

The primary objective of this study was to assess the efficacy of an Internet-mediated, pedometer-based intervention designed to increase walking and health related quality of life for Veterans with COPD. The specific aims of this randomized controlled trial (RCT) with a wait list control were: 1) To test the effectiveness of an automated internet-mediated walking program for veterans with COPD with a primary outcome of improvement in health related quality of life at four months and at one year; 2) to estimate the effect of the internet-mediated walking program for veterans with COPD on all cause days of hospitalization over one year following randomization; and 3) to compare intervention reach, participation and satisfaction outcomes between rural and urban veterans among those randomized to the intervention arm.

Methods:

Participants were followed for 12 months to investigate the efficacy of the intervention in assisting patients with initiating and maintaining a regular walking program and improving health related quality of life. Eligible and consented patients wore a pedometer to obtain one week of baseline data and then were randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm received iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls were notified that they were enrolled, but that their intervention would start in one year; however, they kept the pedometer and had access to a static webpage. Both groups completed on-line survey assessments at baseline, 4, and 12 months, and were asked to report adverse events on a regular basis. The primary outcome was changes in health related quality of life, as measured using the St George's Respiratory Questionnaire (SGRQ), a disease-specific instrument in patients with COPD. Secondary outcomes included days of hospitalization during the one-year intervention period, changes in average daily steps as measured using the study pedometer, self-reported dyspnea, intervention reach, and adverse event rates. The analysis was conducted based [on the original randomized treatment assignment regardless of participation (an intent-to-treat analysis) and included both a complete case analysis as well as an all case analysis using a linear mixed-effects model. Between-group differences in change scores (4 months or 12 months) were estimated after adjusting for baseline values of the outcome variables.

Status:

This study is completed. Data analysis and manuscript preparation continue.

Study Design

• Study Type: Interventional
• Actual Enrollment: 307 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Effectiveness of an Automated Walking Program Targeting Veterans With COPD
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Usual Care Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	Other: Usual Care; Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Other: Internet-mediated Walking Program participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress	Behavioral: automated internet-mediated walking program; intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress

Outcome Measures

Primary Outcome Measures

1. Self-Reported Respiratory-Specific Quality of Life [four months from randomization]

   Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to four months. (Scores range from 0 to 100, with higher scores indicating more limitations.)

2. Self-Reported Respiratory-Specific Quality of Life [twelve months from randomization]

   Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to twelve months. (Scores range from 0 to 100, with higher scores indicating more limitations.)

Secondary Outcome Measures

1. Self Reported Dyspnea [four months from randomization]

   Change in Self Reported Dyspnea from Baseline to 4 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, "0 - I only get breathless with strenuous exercise." and "4 - I am too breathless to leave the house or I am breathless when dressing.")

2. Self Reported Dyspnea [twelve months from randomization]

   Change in Self Reported Dyspnea from Baseline to 12 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, "0 - I only get breathless with strenuous exercise." and "4 - I am too breathless to leave the house or I am breathless when dressing.")

3. Days of Hospitalization [during study participation, up to 12 months]

   Number of days of all-cause hospitalization during study participation.

4. Change in Average Daily Step Counts [baseline and final two weeks of the intervention and the two weeks post intervention.]

   Change in daily step counts compared to baseline and those captured in the final two weeks of the intervention and the two weeks post intervention.

5. Goal Commitment for Intervention Participants [change from four months and twelve months from enrollment]

   Change in goal commitment for intervention participations on a Likert scale from 1-5, with 1 as "Strongly Disagree" and 5 is "Strongly Agree" to the question, "I am strongly committed to pursuing my step count goal." A negative change value indicates lower goal commitment.

6. Study Reach Among Rural Participants [At baseline]

   Calculated by dividing the total number of eligible rural responders by the total number of rural responders to create an eligibility rate, then multiplying the eligibility rate with the total number of letters sent to rural individuals to create a possible rural eligible pool. The total number of eligible rural responders was divided by the possible rural eligible pool.

7. Participant Retention [during study participation, up to twelve months]

   The last valid day of pedometer data or the last login day to the study website for both arms, whichever day was last, from 1-366.

8. Change in Participant Satisfaction [four to twelve months of study participation]

   Change in participation satisfaction with the Intervention group from four to twelve months on a Likert scale of 1-5, where 1 is "Definitely True" 5 is "Definitely False" to the question, "I would recommend the Taking Healthy Steps walking program to another person with COPD". A negative change value indicates higher satisfaction score.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult >= 40 years old

• Diagnosis of COPD, emphysema or chronic bronchitis

• Able to walk a minimum of one block

• Sedentary, defined by less than 150 minutes of self-reported physical activity per week

• Have a doctor or primary care provider in the VA who can provide medical clearance

• Competent to give informed consent

• Must be a regular email user (check weekly)

• Have access to a computer with an internet connection, a USB port, and Windows XP or Vista

Exclusion Criteria:

• Diagnosis codes of quadriplegia and paraplegia or pregnancy-related diagnoses or procedures within the previous year will be excluded from potential participant pool

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Ann Arbor Healthcare System	Ann Arbor	Michigan	United States	48113-0170

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Caroline R Richardson, MD, VA Ann Arbor Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01102777
• Other Study ID Numbers: IIR 09-366
• First Posted: Apr 13, 2010
• Last Update Posted: Jun 7, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by VA Office of Research and Development: internet; walking
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

Participant Flow

Recruitment Details	Recruitment was conducted entirely through mail, phone, or internet. Recruitment start was December 2011.
Pre-assignment Detail	Randomization required Medical Clearance, the completed Baseline Survey, and valid baseline pedometer data. While 307 participants were Consented, only 239 were randomized. The top three reasons for not being randomized were: Pt withdrew prior (23) Failed to submit Medical Clearance and pedometer data (19) or failed to submit Baseline survey (9).

Arm/Group Title	Usual Care	Internet-mediated Walking Program
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Period Title: Overall Study
STARTED	84	155
COMPLETED	75	139
NOT COMPLETED	9	16

Baseline Characteristics

Arm/Group Title	Usual Care	Internet-mediated Walking Program	Total
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress	Total of all reporting groups
Overall Participants	84	155	239
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.4 (9.2)	66.9 (8.7)	66.7 (8.8)
Sex: Female, Male (Count of Participants)
Female	7 8.3%	8 5.2%	15 6.3%
Male	77 91.7%	147 94.8%	224 93.7%
Race/Ethnicity, Customized (participants) [Number]
Black	3 3.6%	7 4.5%	10 4.2%
White	79 94%	143 92.3%	222 92.9%
Other/combined	2 2.4%	5 3.2%	7 2.9%
Region of Enrollment (participants) [Number]
United States	84 100%	155 100%	239 100%
St George's Respiratory Questionnaire (SGRQ) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	46.8 (15.6)	45.5 (15.4)	46.0 (15.4)
Modified Medical Research Council (MMRC) Dyspnea score (participants) [Number]
MMRS Dyspnea Score 0-1	57 67.9%	109 70.3%	166 69.5%
MMRS Dyspnea Score 2-4	27 32.1%	46 29.7%	73 30.5%
Baseline daily step count; mean (steps) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [steps]	3521 (2058)	3484 (2309)	3497 (2220)

Outcome Measures

1. Primary Outcome

Title	Self-Reported Respiratory-Specific Quality of Life
Description	Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to four months. (Scores range from 0 to 100, with higher scores indicating more limitations.)
Time Frame	four months from randomization

Outcome Measure Data

Analysis Population Description

One Intervention participant was dropped from analysis due to being an extreme outlier. In addition, not all participants had complete SGRQ data at both time points for analysis.

Arm/Group Title	Usual Care	Internet-mediated Walking Program
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Measure Participants	77	144
Mean (Standard Deviation) [units on a scale]	-0.8 (10.9)	-3.2 (11.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Internet-mediated Walking Program
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.142
	Comments
	Method	Regression, Linear
	Comments	Adjusted for baseline value of outcome, MMRC dyspnea score, and urban versus rural residence.

2. Primary Outcome

Title	Self-Reported Respiratory-Specific Quality of Life
Description	Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to twelve months. (Scores range from 0 to 100, with higher scores indicating more limitations.)
Time Frame	twelve months from randomization

Outcome Measure Data

Analysis Population Description

One Intervention participant was dropped from analysis due to being an extreme outlier.

Arm/Group Title	Usual Care	Internet-mediated Walking Program
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Measure Participants	84	154
Mean (95% Confidence Interval) [units on a scale]	-1.4	-2.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Internet-mediated Walking Program
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.502
	Comments
	Method	Mixed Models Analysis
	Comments	Based on mixed models, adjusting for group, time, group*time interaction, MMRC score, and urban versus rural residence.

3. Secondary Outcome

Title	Self Reported Dyspnea
Description	Change in Self Reported Dyspnea from Baseline to 4 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, "0 - I only get breathless with strenuous exercise." and "4 - I am too breathless to leave the house or I am breathless when dressing.")
Time Frame	four months from randomization

Outcome Measure Data

Analysis Population Description

One Intervention participant was dropped from analysis due to being an extreme outlier. Three Control and ten Intervention were missing values at 4 months.

Arm/Group Title	Usual Care	Internet-mediated Walking Program
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Measure Participants	81	144
Mean (Standard Deviation) [units on a scale]	-.037 (.8)	.035 (.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Internet-mediated Walking Program
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.90
	Comments
	Method	Regression, Linear
	Comments	Adjusted for baseline value and rural residence.

4. Secondary Outcome

Title	Self Reported Dyspnea
Description	Change in Self Reported Dyspnea from Baseline to 12 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, "0 - I only get breathless with strenuous exercise." and "4 - I am too breathless to leave the house or I am breathless when dressing.")
Time Frame	twelve months from randomization

Outcome Measure Data

Analysis Population Description

One Intervention participant was dropped from analysis due to being an extreme outlier. Nine Control and seventeen Intervention participants were missing data at 12 months.

Arm/Group Title	Usual Care	Internet-mediated Walking Program
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Measure Participants	75	137
Mean (Standard Deviation) [units on a scale]	.013 (.88)	.029 (.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Internet-mediated Walking Program
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.93
	Comments
	Method	Regression, Linear
	Comments	Adjusted for baseline value and rural residence.

5. Secondary Outcome

Title	Days of Hospitalization
Description	Number of days of all-cause hospitalization during study participation.
Time Frame	during study participation, up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Internet-mediated Walking Program
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Measure Participants	84	155
Number [days]	86	286

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Internet-mediated Walking Program
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.08
	Comments
	Method	Zero inflated Poisson regression
	Comments	Adjusted for age, gender, oxygen use, and arm.

6. Secondary Outcome

Title	Change in Average Daily Step Counts
Description	Change in daily step counts compared to baseline and those captured in the final two weeks of the intervention and the two weeks post intervention.
Time Frame	baseline and final two weeks of the intervention and the two weeks post intervention.

Outcome Measure Data

Analysis Population Description

One Intervention participant was dropped from analysis due to being an extreme outlier.

Arm/Group Title	Usual Care	Internet-mediated Walking Program
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Measure Participants	84	154
Mean (95% Confidence Interval) [steps]	163	270

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Internet-mediated Walking Program
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.731
	Comments
	Method	Mixed Models Analysis
	Comments	Based on mixed models, adjusting for group, time, group*time interaction, MMRC score, and urban versus rural residence.

7. Secondary Outcome

Title	Goal Commitment for Intervention Participants
Description	Change in goal commitment for intervention participations on a Likert scale from 1-5, with 1 as "Strongly Disagree" and 5 is "Strongly Agree" to the question, "I am strongly committed to pursuing my step count goal." A negative change value indicates lower goal commitment.
Time Frame	change from four months and twelve months from enrollment

Outcome Measure Data

Analysis Population Description

This measure was only assessed on the Intervention group, and only 146 participants answered the question at either time points.

Arm/Group Title	Usual Care	Internet-mediated Walking Program
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Measure Participants	0	146
Mean (95% Confidence Interval) [units on a scale]	-.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Internet-mediated Walking Program
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.52
	Comments
	Method	Mixed Models Analysis
	Comments	Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.

8. Secondary Outcome

Title	Study Reach Among Rural Participants
Description	Calculated by dividing the total number of eligible rural responders by the total number of rural responders to create an eligibility rate, then multiplying the eligibility rate with the total number of letters sent to rural individuals to create a possible rural eligible pool. The total number of eligible rural responders was divided by the possible rural eligible pool.
Time Frame	At baseline

Outcome Measure Data

Analysis Population Description

number of rural participants.

Arm/Group Title	Usual Care	Intervention
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Measure Participants	37	71
Number [percentage of possible eligible rural]	2.5	2.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Internet-mediated Walking Program
	Comments	The determination of arm occurred after recruitment, and Study Reach is a recruitment value.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Participant Retention
Description	The last valid day of pedometer data or the last login day to the study website for both arms, whichever day was last, from 1-366.
Time Frame	during study participation, up to twelve months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Intervention
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Measure Participants	84	154
Mean (95% Confidence Interval) [day]	308.8	329.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Internet-mediated Walking Program
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.11
	Comments
	Method	Regression, Linear
	Comments	Adjusting for time, MMRC score, and urban versus rural residence.

10. Secondary Outcome

Title	Change in Participant Satisfaction
Description	Change in participation satisfaction with the Intervention group from four to twelve months on a Likert scale of 1-5, where 1 is "Definitely True" 5 is "Definitely False" to the question, "I would recommend the Taking Healthy Steps walking program to another person with COPD". A negative change value indicates higher satisfaction score.
Time Frame	four to twelve months of study participation

Outcome Measure Data

Analysis Population Description

This was only assessed on Intervention group participants who answered the question at either four or twelve months.

Arm/Group Title	Usual Care	Intervention
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
Measure Participants	0	146
Mean (95% Confidence Interval) [units on a scale]	-.14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Internet-mediated Walking Program
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.01
	Comments
	Method	Mixed Models Analysis
	Comments	Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.

Adverse Events

Time Frame	During study participation, up to twelve months.
Adverse Event Reporting Description	Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record
Arm/Group Title	Usual Care		Internet-mediated Walking Program
Arm/Group Description	Control group, instructed to wear the pedometer but not provided with walking goals or instruction.		participants in the intervention arm are asked to participate in a walking program automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
All Cause Mortality
	Usual Care		Internet-mediated Walking Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Usual Care		Internet-mediated Walking Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/84 (22.6%)		44/155 (28.4%)
General disorders
General disorders	19/84 (22.6%)	28	44/155 (28.4%)	64
Other (Not Including Serious) Adverse Events
	Usual Care		Internet-mediated Walking Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	39/84 (46.4%)		90/155 (58.1%)
Cardiac disorders
Cardiac disorders	1/84 (1.2%)	1	3/155 (1.9%)	3
General disorders
Other	3/84 (3.6%)	3	5/155 (3.2%)	6
Musculoskeletal and connective tissue disorders
Musculoskeletal	8/84 (9.5%)	9	43/155 (27.7%)	70
Respiratory, thoracic and mediastinal disorders
Pulmonary	27/84 (32.1%)	35	39/155 (25.2%)	156

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.