Chronic Obstructive Pulmonary DiseaseNCT06077994
Enhanced Pulmonary Rehabilitation With Digital Remote Home Monitoring
A study testing digital Remote Patient Monitoring+BEPR+ (dRPM+) and Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+) in people with Chronic Obstructive Pulmonary Disease, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- digital Remote Patient Monitoring+BEPR+ (dRPM+) and Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Enhanced Pulmonary Rehabilitation Program With Digital Remote Patient Monitoring: A Feasibility Randomized Clinical Trial
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.
Read the 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: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- digital Remote Patient Monitoring+BEPR+ (dRPM+), Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+)
- Keywords
- COPD, Lung diseases, Pulmonary Rehabilitation, Digital health
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital Remote Patient Monitoring+BEPR+ (dRPM+)Behavioural
In addition to the BEPR+ program as described, patients will use the Cloud Dx Connect Health System to take daily physiological readings (Blood pressure, heart rate, oximetry, body temperature and body weight). These data will be transmitted to a secured server supported by the provincial health care system. Participants and therapists will interact with these data in their respective dashboards and in conjunction with participants' determined medical action plan, engage in or make changes to participants current self-management regimens.
Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+)Behavioural
Patients will attend the BEPR+ program 3 days per week for 6 weeks or 2 days per week for 8 weeks (total of 16 sessions). Patients will receive 90 minutes of personalized and supervised exercise training (aerobic and resistance) and 60 minutes of education designed to promote self-management. Patients will also received one-on-one sessions with a therapist to review their medical action plan for exacerbation management, program and lifestyle goals (including physical activity), determine referral needs for other health services (i.e. smoking cessation, weight management, and psychological support). Patients will use an activity monitor for feedback and motivation for physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+) | Active comparator | 6 or 8 weeks BEPR+ program Receives: Behavioral: Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+) |
| digital Remote Patient Monitoring + BEPR+ (dRPM+) | Experimental | 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 Receives: Behavioral: digital Remote Patient Monitoring+BEPR+ (dRPM+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment and participant retention
A measure of the recruitment and retention of study participants
Measured: 18 months
Adherence
adherence to vital sign monitoring during the 6 or 8 week pulmonary rehabilitation trial and the 12 week follow-up period.
Measured: 18 months
Acceptability
Using a fit for purpose questionnaire to evaluate participant acceptance of the remote patient monitoring system.
Measured: 18 months
Secondary outcomes (8)
Staffing time and resources
An assessment of the time requirement to monitor and respond to remote patient monitoring notifications
Measured: 18 months
Self-efficacy for managing chronic disease-6 items
A generic 6-item tool used to measure of patient's confidence in self-managing their chronic health condition(s). Patients are score each item from 0-10,and the average is reported as the score. Higher scores indicate higher self-efficacy.
Measured: Baseline, post-program, and 12-week follow-up
Partners in Health Self-Management tool
A generic self-reported questionnaire used to assess the self-management knowledge and behaviors or people with chronic diseases. Higher scores indicate better self management knowledge and behaviors.
Measured: Baseline, post-program, and 12-week follow-up
Self-efficacy for exercise and physical activity
A nine item self-reported scale describing different situations (weather, boredom, pain, exercising alone, not pleasurable, too busy, feel tired, stress, depressed) that might effect participation in exercise. The scale asks patients to report their confidence to exercise (from 0- not confident to 10-very confident) 3 times a week for 20 minutes each time despite the above situations.
Measured: Baseline, post-program, and 12-week follow-up
Physical activity levels
Using the Fitbit Versa 4 and measuring step count, active minutes, and sleep
Measured: Baseline, post-program, and 12-week follow-up
Functional exercise capacity assessed by the 6-minute walk test
A self-paced standardized walking test with the primary outcome of 6-minute walk distance as proxy for patients' exercise capacity
Measured: Baseline, post-program, and 12-week follow-up
Health status as assessed by the COPD Assessment Tool
A unidimensional 8-items questionnaire to evaluate the impact of symptoms on patients' health status. Higher scores indicate higher degree of symptoms and a poorer health status.
Measured: Baseline, post-program, and 12-week follow-up
General health related quality of life as assessed by the EuroQol 5 dimensions 5 level (EQ5D5L) questionnaire.
A unidimensional tool that assessed the impact of disease on 5 areas of general health
Measured: Baseline, post-program, and 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start28 Sep 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael K Stickland, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077994
- Sponsor's protocol ID
- Pro00066560-2
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Enhanced Pulmonary Rehabilitation Program With Digital Remote Patient Monitoring: A Feasibility Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06077994
- Acronym / sponsor ID
- Pro00066560-2
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Lung diseases, Pulmonary Rehabilitation, Digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+) | Active comparator | Behavioral: Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+)6 or 8 weeks BEPR+ program |
| digital Remote Patient Monitoring + BEPR+ (dRPM+) | Experimental | 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 |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital Remote Patient Monitoring+BEPR+ (dRPM+)In addition to the BEPR+ program as described, patients will use the Cloud Dx Connect Health System to take daily physiological readings (Blood pressure, heart rate, oximetry, body temperature and body weight). These data will be transmitted to a secured server supported by the provincial health care system. Participants and therapists will interact with these data in their respective dashboards and in conjunction with participants' determined medical action plan, engage in or make changes to participants current self-management regimens. | Behavioural | digital Remote Patient Monitoring + BEPR+ (dRPM+) |
| Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+)Patients will attend the BEPR+ program 3 days per week for 6 weeks or 2 days per week for 8 weeks (total of 16 sessions). Patients will receive 90 minutes of personalized and supervised exercise training (aerobic and resistance) and 60 minutes of education designed to promote self-management. Patients will also received one-on-one sessions with a therapist to review their medical action plan for exacerbation management, program and lifestyle goals (including physical activity), determine referral needs for other health services (i.e. smoking cessation, weight management, and psychological support). Patients will use an activity monitor for feedback and motivation for physical activity. | Behavioural | Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+) |
Primary outcome
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.
8 secondary outcomes
Staffing time and resources
Time frame: 18 months
Self-efficacy for managing chronic disease-6 items
Time frame: Baseline, post-program, and 12-week follow-up
Partners in Health Self-Management tool
Time frame: Baseline, post-program, and 12-week follow-up
Self-efficacy for exercise and physical activity
Time frame: Baseline, post-program, and 12-week follow-up
Physical activity levels
Time frame: Baseline, post-program, and 12-week follow-up
Functional exercise capacity assessed by the 6-minute walk test
Time frame: Baseline, post-program, and 12-week follow-up
Health status as assessed by the COPD Assessment Tool
Time frame: Baseline, post-program, and 12-week follow-up
General health related quality of life as assessed by the EuroQol 5 dimensions 5 level (EQ5D5L) questionnaire.
Time frame: Baseline, post-program, and 12-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael K Stickland, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital Remote Patient Monitoring+BEPR+ (dRPM+) and Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+) in people with Chronic Obstructive Pulmonary Disease, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment and participant retention (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.