Clinical trial NCT03794921: COPD Access to Pulmonary Rehabilitation Intervention
Official title: Leveraging Technology to Address Access and Adherence to Conventional Hospital-Based Pulmonary Rehabilitation in Veterans With COPD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD
Keywords: Pulmonary Rehabilitation
Technology-Mediated
Web-Based Intervention
Physical Activity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-01-07
Enrollment: 103
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 would benefit from but cannot access 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.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects, greater than or equal to 40 years of age
* Clinical diagnosis of COPD defined as either a ratio of FEV1 to forced vital capacity (FVC) \< 0.70 or chest CT evidence of emphysema or prior documentation of FEV1/FVC ratio of \< 0.7 and clinical evidence of COPD

  * defined as 10 pack-year cigarette smoking history
  * dyspnea
  * or on bronchodilators
* Have declined participation in or cannot access a conventional pulmonary rehabilitation program
* Medical clearance from healthcare provider to participate in an exercise program
* Have access to a computer with Internet connection, a USB port or Bluetooth capability, and Windows XP/Vista/7/8/10 or higher, or Mac OSX 10.5 or higher operating system, or willing to come to VA Medical Center to use study computers
* Competent to provide informed consent
* Willingness to make return visits and be available by telephone for duration of study

Exclusion Criteria:

* COPD exacerbation in the previous 1 month
* Inability to ambulate with or without assistance (if remote)
* On supplemental oxygen (if remote)
* Use of walking assistive device (if remote)
* Inability to complete questionnaires
* Inability to collect at least 7 of 10 days of baseline step counts
* Participation in a pulmonary rehabilitation program at time of screening or within the previous 3 months
* Participation in another exercise-related research study at time of screening
* Plans to participate in an exercise-related research study in the next 3 months
* Average baseline step counts of greater than or equal to 10,000 steps per week

Primary outcomes:
measure: Physical Activity measured as Daily Step Count
timeFrame: 12 weeks
Secondary outcomes:
measure: Exercise Self-Regulatory Efficacy
timeFrame: 12 weeks
measure: Health-Related Quality of Life using a disease specific questionnaire
timeFrame: 12 weeks
measure: Shortness of Breath rating as perceived by the participant
timeFrame: 12 weeks
measure: Healthcare Utilization represented by number of Acute Exacerbations and Hospitalizations over timeframe
timeFrame: 12 weeks
measure: Amount of Depression experienced by the participant
timeFrame: 12 weeks and 6 months
Other outcomes:
measure: Health Utilities
timeFrame: 12 weeks
measure: Number of participants who enroll in Conventional Pulm Rehab after participating in the research study
timeFrame: 12 weeks
measure: COPD Knowledge
timeFrame: 12 weeks
measure: Sleepiness
timeFrame: 12 weeks
measure: Social Support
timeFrame: 12 weeks
measure: Brief Pain Inventory
timeFrame: 12 weeks
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Marilyn L. Moy, MD
role: PRINCIPAL_INVESTIGATOR
References: