Clinical trial NCT06077994: Enhanced Pulmonary Rehabilitation With Digital Remote Home Monitoring
Official title: The Enhanced Pulmonary Rehabilitation Program With Digital Remote Patient Monitoring: A Feasibility Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lung diseases
Pulmonary Rehabilitation
Digital health
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 78
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. To assess adherence to and completion of the intervention (i.e., do participants complete the PR classes and take daily physiological readings as prescribed?).
2. To assess recruitment and retention rates.
3. To assess the acceptability of the intervention to individuals undergoing PR.
4. 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: A randomized parallel-controlled trial will be implemented at the G.F. MacDonald Centre for Lung Health where entire PR classes I(i.e., delivered Tuesday/Thursday or Monday/Wednesday/Friday) will be block randomized according to a random numbers table to receive the intervention (dRPM+) or the control (BEPR+). Both groups will complete survey and questionnaire data at baseline, post-program, and 12-week follow-up using a REDcap database.

Study design A randomized parallel-controlled trial will be implemented at the G.F. MacDonald Centre for Lung Health. Entire PR classes I(i.e., delivered Tuesday/Thursday for 8 weeks or Monday/Wednesday/Friday for 6 weeks.) will be block randomized according to a random numbers table to receive dRPM+ or BEPR+. In addition to the BEPR+ program, both groups will complete survey and questionnaire data at baseline, specific points throughout the program, post-program, and 12-week follow-up using a REDcap database.

Data Analysis: Data will be presented descriptively and encompass all key relevant summary statistics (such as mean, median, standard deviation, and range). These data will cover various aspects, including participant characteristics, the primary feasibility outcome (dRPM data collection rate), study recruitment and retention, program attendance, patient satisfaction, staff time, questionnaire completion rate and time required. Regression analyses will explore changes in the secondary outcomes while controlling for the effects of potential covariates, including age, sex, disease severity, comorbidities and physical activity.

Data Handling and Record Keeping: Data will be stored in a central Redcap database. Patients will all have a unique study code number, the unique identifier in the Redcap database. A comparison of participants who consented, those who declined to join the trial, and those who completed or dropped out of the program will be conducted using student t-tests. The occurrence of adverse events, relevant staffing time, and resource details will be reported as counts along with qualitative descriptions.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of recruitment and participant retention
timeFrame: 18 months
measure: Adherence
timeFrame: 18 months
measure: Acceptability
timeFrame: 18 months
Secondary outcomes:
measure: Staffing time and resources
timeFrame: 18 months
measure: Self-efficacy for managing chronic disease-6 items
timeFrame: Baseline, post-program, and 12-week follow-up
measure: Partners in Health Self-Management tool
timeFrame: Baseline, post-program, and 12-week follow-up
measure: Self-efficacy for exercise and physical activity
timeFrame: Baseline, post-program, and 12-week follow-up
measure: Physical activity levels
timeFrame: Baseline, post-program, and 12-week follow-up
measure: Functional exercise capacity assessed by the 6-minute walk test
timeFrame: Baseline, post-program, and 12-week follow-up
measure: Health status as assessed by the COPD Assessment Tool
timeFrame: Baseline, post-program, and 12-week follow-up
measure: General health related quality of life as assessed by the EuroQol 5 dimensions 5 level (EQ5D5L) questionnaire.
timeFrame: Baseline, post-program, and 12-week follow-up
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: G. F. MacDonald Centre for Lung Health
state: Alberta
Study officials:
affiliation: University of Alberta
name: Michael K Stickland, PhD
role: PRINCIPAL_INVESTIGATOR
References: