The Enhanced Pulmonary Rehabilitation Program With Digital Remote Patient Monitoring: A Feasibility Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Feasibility of recruitment and participant retention
Study Overview
Brief Summary
The primary objective of the current randomized controlled trial is to assess feasibility of integrating digital remote patient monitoring (dRPM) with the an enhanced Breathe Easy Pulmonary Rehabilitation Program for Individuals with COPD and Comorbidities (BEPR+), including aspects such as recruitment, retention, patient adherence, technology acceptability, adverse events, and staffing resources. The secondary objectives include comparing clinical outcomes (such as functional capacity, health status, quality of life, self-management, psychosocial health, physical activity and self-efficacy) between those who receive dRPM and BEPR+ (dRPM+) vs. those who receive BEPR+ alone.
Detailed Description
Background Chronic obstructive pulmonary disease (COPD) represents a major challenge to health and well-being, necessitating the development of effective management strategies. Pulmonary rehabilitation (PR) has emerged as a crucial approach. However, due to the complexity of COPD and the presence of comorbidities, there is a need for an advanced PR program that can address the diverse needs of patients, including better self-management. In response to this challenge, clinicians and researchers at the G.F. MacDonald Centre for Lung Health have created BEPR+. This program addresses the needs of comorbid COPD patients via a more comprehensive comorbidities assessment, collaborative goal setting process to adopt healthier lifestyle behaviors (with a strong emphasize in physical activity), and a protocolized referral process to facilitate a more comprehensive care approach.
A proposed solution to address better patient self-management following PR involves integrating digital remote patient monitoring (dRPM) into BEPR+ (dRPM+), effectively bridging the gap between self-care and healthcare. The dRPM system will collect and transmit patient-generated data to healthcare providers, enabling timely detection of exacerbations and ultimately reducing hospitalizations. Participants will be educated on monitoring trends in their daily vital signs, allowing early identification of abnormalities that may correlate with changes in symptoms and general health status.
Primary Objective: To assess the feasibility and acceptability of the dRPM+ intervention in individuals undergoing PR. More specifically, the primary objectives are as follows:
- To assess adherence to and completion of the intervention (i.e., do participants complete the PR classes and take daily physiological readings as prescribed?).
- To assess recruitment and retention rates.
- To assess the acceptability of the intervention to individuals undergoing PR.
- To assess the impact on staff workflow and program resources.
Secondary Objectives: To estimate the impact of the program on self-management, self-efficacy, and standard PR outcomes (i.e., functional capacity, health status, general quality of life, psychosocial health, and physical activity) by generating preliminary estimates of the mean difference between groups over time for each outcome measure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients must be enrolled into pulmonary rehabilitation at the G.F. MacDonald Centre for Lung Health with a diagnosis of chronic lung disease (COPD confirmed by post-bronchodilator forced expiratory volume in 1 second by forced vital capacity (FEV1/FVC) ratio of less than 0.7).
- •Patients must be able to read and communicate in English and willing and able to use digital devices.
Exclusion Criteria
- •Patients with cognitive impairments who are unable to accurately complete questionnaires will also be excluded.
- •As part of standard rehabilitation referral procedures, all patients must be ambulatory and not have unstable cardiovascular disease.
Arms & Interventions
Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+)
6 or 8 weeks BEPR+ program
Intervention: Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+) (Behavioral)
digital Remote Patient Monitoring + BEPR+ (dRPM+)
6 or 8 weeks BEPR+; daily vitals readings (blood pressure, heart rate, oximetry, body temperature, and body weight) and an additional 12 weeks of dRPM reading once the BEPR+ program concludes
Intervention: digital Remote Patient Monitoring+BEPR+ (dRPM+) (Behavioral)
Outcomes
Primary Outcomes
Feasibility of recruitment and participant retention
Time Frame: 18 months
A measure of the recruitment and retention of study participants
Adherence
Time Frame: 18 months
adherence to vital sign monitoring during the 6 or 8 week pulmonary rehabilitation trial and the 12 week follow-up period.
Acceptability
Time Frame: 18 months
Using a fit for purpose questionnaire to evaluate participant acceptance of the remote patient monitoring system.
Secondary Outcomes
- Physical activity levels(Baseline, post-program, and 12-week follow-up)
- Partners in Health Self-Management tool(Baseline, post-program, and 12-week follow-up)
- Self-efficacy for exercise and physical activity(Baseline, post-program, and 12-week follow-up)
- Self-efficacy for managing chronic disease-6 items(Baseline, post-program, and 12-week follow-up)
- Functional exercise capacity assessed by the 6-minute walk test(Baseline, post-program, and 12-week follow-up)
- Staffing time and resources(18 months)
- General health related quality of life as assessed by the EuroQol 5 dimensions 5 level (EQ5D5L) questionnaire.(Baseline, post-program, and 12-week follow-up)
- Health status as assessed by the COPD Assessment Tool(Baseline, post-program, and 12-week follow-up)