COPD
Conditions
Keywords
Pulmonary Rehabilitation, Technology-Mediated, Web-Based Intervention, Physical Activity
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.
Interventions
OTHEREvery Step Counts
Pedometer coupled to a website that provides step-count goals, feedback, education, motivation, and social support.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Study staff communicating randomization assignments to subjects will be different from study staff conducting follow-up outcome assessments.
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Measured as Change in Average Daily Step Count | 12 weeks compared to baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Self-Regulatory Efficacy Measured as Change Score | 12 weeks compared to baseline | 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. |
| Disease Specific Health-Related Quality of Life Measured as Change Score | 12 weeks compared to baseline | 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. |
| Shortness of Breath Rating as Perceived by the Participant Measured as Change Score | 12 weeks compared to baseline | 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. |
| Depression Self-reported on Questionnaire Measured as Change Score | 12 weeks compared to baseline | 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. |
| CHAMPS Physical Activity Questionnaire Measured as Change Score | 12 weeks compared to baseline | 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. |
| Rapid Assessment of Physical Activity (RAPA) Questionnaire | 12 weeks compared to baseline | 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. |
| Healthcare Utilization Represented by Number of Hospitalizations Over Timeframe | 12 weeks | Hospitalization History. Assessment of total number of all cause hospitalizations over the timeframe of 12 weeks based on self-report. |
| Healthcare Utilization Represented by Number of Acute Exacerbations Over Timeframe | 12 weeks | Acute Exacerbation History. Assessment of total number of acute exacerbations (AEs) over the timeframe of 12 weeks based on self-report. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarilyn L. Moy, MD
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Participant flow
Recruitment details
Participants were enrolled from September, 2019-June, 2024 at VA Boston. 146 consented; 109 randomized (57 allocated to intervention, 52 allocated to usual care); 109 included in final analysis and analyzed as intention-to-treat
Pre-assignment details
37 not randomized (28 ineligible, 5 lost to follow-up, 4 withdrew)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 72.6 years STANDARD_DEVIATION 8.2 |
| Daily Step Count Average | 4,222 steps per day |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| FEV1 Percent Predicted | 73.2 percent predicted of FEV1 STANDARD_DEVIATION 24.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 96 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 1 / 52 |
| other Total, other adverse events | 38 / 57 | 21 / 52 |
| serious Total, serious adverse events | 7 / 57 | 3 / 52 |
Outcome results
None listed