COPD Access to Pulmonary Rehabilitation Intervention (CAPRI)
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|ClinicalTrials.gov Identifier: NCT03794921|
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : September 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD||Other: Every Step Counts||Not Applicable|
Conventional pulmonary rehabilitation (PR) programs are highly effective and the standard of care in patients with chronic obstructive pulmonary disease (COPD). PR faces two significant problems: (1) most patients with COPD who would benefit from PR cannot access it, and 2) there is no effective long-term strategy to maintain physical activity (PA) and benefits after completing PR. The investigators propose a randomized controlled trial (RCT) to test the efficacy of a technology-mediated intervention to increase PA in persons with COPD who cannot access conventional, hospital-based PR. The investigators also propose a non-randomized study to explore the ability of the PA intervention to maintain PA and exercise adherence, extending the benefits of PR, in persons with COPD who complete a conventional PR program. COPD is the third leading cause of death in the United States; an estimated 16 million Americans have COPD. Despite maximal medical therapy, patients with COPD characteristically experience breathlessness, which leads to a downward spiral of sedentary behavior, physical inactivity, deconditioning, and functional disability. Low physical activity is associated with poor outcomes in COPD--increased risk of acute exacerbations, hospitalizations, and death, independent of lung function. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend regular PA for all patients with COPD. Conventional, supervised PR programs clearly reduce breathlessness, and improve health-related quality of life (HRQL) and exercise capacity. However, PR programs face significant challenges of access and adherence. The investigators developed Every Step Counts (ESC), a technology-mediated intervention based on the Behavioral Theory of Self-Regulation, to target sedentary behavior, promote PA, and alleviate deconditioning. ESC couples a website with a pedometer to directly monitor step counts. The website provides individualized step-count goals, iterative feedback, education on disease self-management, motivation, and an online community of social support. In two randomized studies in Veterans with COPD, the investigators demonstrated ESC's safety, feasibility, and efficacy to increase PA. Accessible via the internet and available at any time from home, ESC could be an ideal low-cost platform to address the limitations of conventional PR. The investigators hypothesize that ESC may be an efficacious strategy to promote PA in the many patients who cannot attend a PR program, and may be an option to maintain engagement in PA after patients complete a conventional PR program.
Primary Aim 1: Determine the efficacy of a web-based intervention, ESC, to increase PA (measured directly with an accelerometer and a questionnaire that assesses intensity), compared to usual care, in persons with COPD who are referred to conventional PR but who cannot access it.
Secondary Aim 2: Estimate the effect of the ESC intervention on (a) exercise adherence, (b) exercise self-efficacy, (c) HRQL, (d) dyspnea, (e) anxiety and depression, (f) exercise capacity, and (g) risk of acute exacerbations and COPD-related hospitalizations, compared to usual care.
Exploratory Aim 3: Assess the ability of ESC to maintain PA and exercise adherence, and extend the benefits of PR, in participants with COPD who have completed conventional PR.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||As the primary aim, the investigators propose a RCT to study the efficacy of a web-based, pedometer-mediated physical activity intervention to increase physical activity in persons with COPD who decline conventional pulmonary rehabilitation, compared to usual care. The investigators anticipate that 120 subjects will be randomized 1:1 to either the intervention or usual care.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Study staff communicating randomization assignments to subjects will be different from study staff conducting follow-up outcome assessments.|
|Official Title:||Leveraging Technology to Address Access and Adherence to Conventional Hospital-Based Pulmonary Rehabilitation in Veterans With COPD|
|Actual Study Start Date :||September 2, 2019|
|Estimated Primary Completion Date :||April 3, 2023|
|Estimated Study Completion Date :||April 1, 2024|
No Intervention: Usual Care
Patients referred to conventional PR but declined. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
Experimental: Every Step Counts Intervention
Patients referred to conventional PR but declined. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website as often as they wish, but at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be prominently displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
Other: Every Step Counts
Pedometer coupled to a website that provides step-count goals, feedback, education, motivation, and social support.
- Physical Activity measured as Daily Step Count [ Time Frame: 12 weeks ]Daily Step Count directly measured with a monitoring device.
- Exercise Adherence [ Time Frame: 12 weeks ]Patient self-report using daily logs.
- Exercise Self-Regulatory Efficacy [ Time Frame: 12 weeks ]Assessed by the Exercise Self-Regulatory Efficacy Scale questionnaire. 16-item questionnaire. Participants indicate their confidence level from 0% (not at all confident) to 100% (highly confident).
- Health-Related Quality of Life using a disease specific questionnaire [ Time Frame: 12 weeks ]Assessed by the St. George's Respiratory Questionnaire. The investigators will use the Total Score and the 3 Domains of Activity, Symptoms, and Impacts. Scores range from 0 to 100, with lower scores representing better health related quality of life.
- Shortness of Breath rating as perceived by the participant [ Time Frame: 12 weeks ]Shortness of Breath is one outcome measured in 2 ways. It will be assessed by the University of California, San Diego (UCSD) Shortness of Breath (SOB) Questionnaire and the modified Medical Research Council scale. The UCSD SOB Questionnaire contains 24 items with scores ranging from 0 to 120. The modified Medical Research Council (mMRC) dyspnea scale ranges from 0 to 4, with higher numbers representing more shortness of breath.
- Level of Anxiety experienced by the participant [ Time Frame: 12 weeks ]Assessed by the Generalized Anxiety Disorder 7-item scale (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety.
- Exercise Capacity [ Time Frame: 12 weeks ]6-minute walk test distance measured in meters.
- Healthcare Utilization represented by number of Acute Exacerbations and Hospitalizations over timeframe [ Time Frame: 12 weeks and 6 months ]Acute Exacerbation and Hospitalization History. Assessment of total number of acute exacerbations (AEs) and hospitalizations over the timeframe of 12 weeks and 6 months is based on both self-report and medical chart review.
- Amount of Depression experienced by the participant [ Time Frame: 12 weeks ]Depression measured by the Beck's Depression Inventory-II questionnaire. 21-items. Scores range with 0 to 63 with higher scores representing greater severity of depression.
- Brief Pain Inventory [ Time Frame: 12 weeks ]Pain Severity Score (8 items) is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10. Pain Interference Score is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.
- Health Utilities [ Time Frame: 12 weeks ]EuroQoL 5-Dimension Health Questionnaire (EQ-5D) Health Utilities. 2 pages assesses 5 dimensions with visual analog scale. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. The EQ VAS (EQ visual analogue scale) records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'.
- Number of participants who enroll in Conventional Pulm Rehab after participating in the research study [ Time Frame: 12 weeks and 6 months ]Numbers will be assessed by self-report and chart review.
- COPD Knowledge [ Time Frame: 12 weeks ]Bristol COPD Knowledge Questionnaire. 13-items that usually takes between 10 and 20 minutes to complete. Percent of questions scored correctly is assessed and range from 0 to 100 %..
- Sleepiness [ Time Frame: 12 weeks ]
Epworth Sleepiness Scale. 8 questions, each on a scale of 0-3. Minimum score is 0 and maximum score is 24.
0-5 Lower Normal Daytime Sleepiness 6-10 Higher Normal Daytime Sleepiness 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness 16-24 Severe Excessive Daytime Sleepiness
- Social Support [ Time Frame: 12 weeks ]MOS Social Support Survey. 18 items with scores ranging from 0 to 100, with higher scores representing greater social support.
- Lung Function [ Time Frame: 12 weeks ]Spirometry assessment of forced expiratory volume in 1 second (FEV1)
- Concentration of C-reactive protein [ Time Frame: 12 weeks ]Blood protein marker of systemic inflammation. Blood draw for C-reactive protein (CRP) with units of mg/L
- Concentration of Interleukin-6 [ Time Frame: 12 weeks ]Blood protein marker of systemic inflammation. Blood draw for Interleukin-6 (IL-6) with units of ng/mL
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794921
|Contact: Marilyn L Moy, MD||(857) 203-6622||Marilyn.Moy@va.gov|
|Contact: Eric Garshick, MD||(857) 203-5536||Eric.Garshick@va.gov|
|United States, Massachusetts|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA||Recruiting|
|Boston, Massachusetts, United States, 02130|
|Contact: Marilyn L Moy, MD 857-203-6622 Marilyn.Moy@va.gov|
|Contact: Eric Garshick, MD (857) 203-5536 Eric.Garshick@va.gov|
|Principal Investigator: Marilyn L. Moy, MD|
|Principal Investigator:||Marilyn L. Moy, MD||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|