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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of an Automated Walking Program Targeting Veterans With COPD

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Behavioral: automated internet-mediated walking program
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Care<br>Control group, instructed to wear the pedometer but not provided with walking goals or instruction. | Other: Usual Care<br>* Control group, instructed to wear the pedometer but not provided with walking goals or instruction.<br>|
| Other: Internet-mediated Walking Program<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Respiratory-Specific Quality of Life | 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.) | four months from randomization | 
| Self-Reported Respiratory-Specific Quality of Life | 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.) | twelve months from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Reported Dyspnea | 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.) | four months from randomization | 
| Self Reported Dyspnea | 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.) | twelve months from randomization | 
| Days of Hospitalization | Number of days of all-cause hospitalization during study participation. | during study participation, up to 12 months | 
| Change in Average Daily Step Counts | 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. | baseline and final two weeks of the intervention and the two weeks post intervention. | 
| Goal Commitment for Intervention Participants | 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. | change from four months and twelve months from enrollment | 
| Study Reach Among Rural Participants | 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. | At baseline | 
| Participant Retention | 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. | during study participation, up to twelve months | 
| Change in Participant Satisfaction | 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. | four to twelve months of study participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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internet, walking