COPD Access to Pulmonary Rehabilitation Intervention

COPD Clinical Trial

— CAPRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03794921
• Other study ID #: F2855-R
• Secondary ID: I01RX002855
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: Marilyn L Moy, MD
• Phone: (857) 203-6622
• Email: Marilyn.Moy[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Every Step Counts
Pedometer coupled to a website that provides step-count goals, feedback, education, motivation, and social support.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Utilities	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'.	12 weeks
Other	Number of participants who enroll in Conventional Pulm Rehab after participating in the research study	Numbers will be assessed by self-report and chart review.	12 weeks
Other	COPD Knowledge	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 %.	12 weeks
Other	Sleepiness	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	12 weeks
Other	Social Support	MOS Social Support Survey. 18 items with scores ranging from 0 to 100, with higher scores representing greater social support.	12 weeks
Other	Brief Pain Inventory	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.	12 weeks
Primary	Physical Activity measured as Daily Step Count	Daily Step Count directly measured with a monitoring device.	12 weeks
Secondary	Exercise Self-Regulatory Efficacy	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).	12 weeks
Secondary	Health-Related Quality of Life using a disease specific questionnaire	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.	12 weeks
Secondary	Shortness of Breath rating as perceived by the participant	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.	12 weeks
Secondary	Healthcare Utilization represented by number of Acute Exacerbations and Hospitalizations over timeframe	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.	12 weeks
Secondary	Amount of Depression experienced by the participant	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.	12 weeks and 6 months