COPD Access to Pulmonary Rehabilitation Intervention (CAPRI)

Leveraging Technology to Address Access and Adherence to Conventional Hospital-Based Pulmonary Rehabilitation in Veterans With COPD

Persons with COPD have significant functional disability but cannot access rehabilitative treatment at hospital-based conventional pulmonary rehabilitation (PR) programs. This project will determine whether an Internet-mediated, pedometer-based walking program can increase physical activity in persons with COPD who qualify for but cannot access PR, compared to usual care. This proposal has high potential to deliver an immediate solution to a pressing clinical need. The proposed research addresses Rehabilitation R&D Service's current priority area of improving disabled Veterans' health-related quality of life by reducing disease burden and maximizing functional recovery.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Every Step Counts

Detailed Description

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 qualify for but cannot access conventional, hospital-based PR. COPD is a 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.

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 or eligible for conventional PR but who cannot access it.

Secondary Aim 2: Estimate the effect of the ESC intervention on (a) exercise self-efficacy, (b) HRQL, (c) dyspnea, (d) depression, and (e) risk of acute exacerbations and COPD-related hospitalizations, compared to usual care.

All study visits are performed either in-person or remotely starting September, 2021.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130-4817
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria are:

1. Male and female subjects, greater than or equal to 40 years of age
2. Clinical diagnosis of COPD defined as: 1 of the following as testing-based evidence of COPD (any documented FEV1/FVC < 0.70, chest CT evidence of emphysema) AND at least 2 of the following as clinical evidence of COPD (≥ 10 pack-year cigarette smoking history, taking an antimuscarinic inhaler such as ipratropium or tiotropium, diagnosis of COPD written in a provider's note or on problem list)
3. Have declined participation in a conventional pulmonary rehabilitation program
4. Medical clearance from healthcare provider to participate in an exercise program
5. Have Internet connection and Bluetooth capability, and access to video platform Cisco Webex#
6. Answer yes to "Does your shortness of breath interfere with your functioning?"
7. Answer no to "Are you interested in joining PR now? If they answer yes, they will be ineligible and the PI will place a consult to PR for further evaluation
8. Competent to provide informed consent
9. Willingness to make return visits and be available by telephone for duration of study

Exclusion Criteria are:

1. COPD exacerbation in the previous 1 month
2. Prescribed supplemental oxygen for activity+
3. Inability to ambulate with or without assistance
4. Use of assistive device for walking such as cane or walker*
5. Inability to complete questionnaires
6. Inability to collect at least 7 of 10 days of baseline step counts
7. Participation in a pulmonary rehabilitation program at time of screening or within the previous 3 months
8. Participation in another exercise-related research study at time of screening
9. Plans to participate in an exercise-related research study in the next 3 months

10. Average baseline step counts of greater than or equal to 10,000 steps per week

    • For those who wish to participate virtually.

      • If participant has an in-person visit, oxygen will be assessed during the 6MWT to determine if subject's oxygen is stable during activity. If a participant has an in-person visit and oxygen is documented during the 6MWT and stays above 85%, he/she will be eligible to participate.

        • If a participant uses an assistive walking device but we have previously shown that the Fitbit pedometer is accurate in him/her (before the study was transitioned to virtual) he/she will be allowed to participate in the study. If a participant has an in-person visit and Fitbit accuracy is documented during use of the assistive device he/she will be eligible to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Patients referred to conventional PR or eligible for PR but declined or cannot access. 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 or eligible for PR but declined or cannot access. 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 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Measured as Change in Average Daily Step Count	Daily Step Count was directly measured with a wearable monitoring device. Change in daily step count at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Self-Regulatory Efficacy Measured as Change Score	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). Change in EX-SRES score at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline
Disease Specific Health-Related Quality of Life Measured as Change Score	Assessed by the St. George's Respiratory Questionnaire. The investigators will use the Total Score which ranges from 0 to 100, with lower scores representing better health related quality of life. Change in total score at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline
Shortness of Breath Rating as Perceived by the Participant Measured as Change Score	The modified Medical Research Council (mMRC) dyspnea scale ranges from 0 to 4, with higher numbers representing more shortness of breath. Change at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline
Depression Self-reported on Questionnaire Measured as Change Score	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. Change in score at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline
CHAMPS Physical Activity Questionnaire Measured as Change Score	Self-reported PA will be assessed with The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity questionnaire, a 41-item measure of the frequency and duration of PA over a typical week over the past four weeks that is used to calculate estimated caloric expenditure per week. Change in score at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline
Rapid Assessment of Physical Activity (RAPA) Questionnaire	Self-reported physical activity intensity was measured with the 7-item Rapid Assessment of PA (RAPA) questionnaire. Levels placed into three categories based on the highest physical activity level affirmatively endorsed: sedentary (score=1), underactive (score=2-5), and active (score >6) at 12 weeks compared to baseline.	12 weeks compared to baseline
Healthcare Utilization Represented by Number of Hospitalizations Over Timeframe	Hospitalization History. Assessment of total number of all cause hospitalizations over the timeframe of 12 weeks based on self-report.	12 weeks
Healthcare Utilization Represented by Number of Acute Exacerbations Over Timeframe	Acute Exacerbation History. Assessment of total number of acute exacerbations (AEs) over the timeframe of 12 weeks based on self-report.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Utilities Measured as Change Score	EuroQoL 5-Dimension Health Questionnaire (EQ-5D) Health Utilities. The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of the United States. Scale ranges from -0.573 to 1 for the United States, with -0.573 indicating the worst health state and 1 indicating the best health state. Change in score at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline
Number of Participants Who Plan to Enroll in Conventional Pulmonary Rehabilitation After Participating in the Research Study	Numbers were assessed by self-report.	12 weeks
COPD Knowledge Measured as Change Score	Bristol COPD Knowledge Questionnaire was used. 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 %. Change in score at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline
Sleepiness Measured as Change Score	Epworth Sleepiness Scale was used. 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. Change in score at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline
Social Support Measured as Change Score	MOS Social Support Survey was used. 18 items with scores ranging from 0 to 100, with higher scores representing greater social support. Change in score at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline
General Health-Related Quality of Life Measured as Change Score	The Veterans RAND-36 is a 36-item self-report measure of general HRQL in U.S. Veterans based on the original RAND SF-36. Items assess participants' perception of their physical and mental health. Physical health (PCS) and mental health (MCS) component scores will be calculated as t scores normed to the general U.S. Veteran population with a mean score of 50 and a standard deviation of 10, with higher scores indicating better health outcomes. Change score at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline
Change in 6-Minute Walk Test Distance	In-clinic test that measures exercise capacity. Change in 6MWT distance at 12 weeks compared to baseline from the adjusted mixed model.	12 weeks compared to baseline

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Marilyn L. Moy, MD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): September 10, 2024
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Pulmonary Rehabilitation; Web-Based Intervention; Technology-Mediated
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Behavior; Pulmonary Disease, Chronic Obstructive; Motor Activity
• Other Study ID Numbers: F2855-R; I01RX002855 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication.

• A local privacy officer will certify that a dataset contains no Protected Health Information (PHI), Personally Identifiable Information (PII), or VA Sensitive Information prior to release outside VA.
• Final data sets will be maintained locally on a secure server or comparable data storage appliance inside the VA network until enterprise-level resources become available for long-term storage and access.

The PI will create de-identified, study-specific datasets. Investigators requesting a copy of a dataset will sign a Letter of Agreement or a Data Use Agreement. A local privacy officer will certify that a dataset contains no PHI, PII, or VA Sensitive Information prior to release outside VA.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No