Enhanced Pulmonary Rehabilitation With Digital Remote Home Monitoring

NCT06077994 | Completed

• 1 other identifier: Pro00066560-2
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Lung diseases; Pulmonary Rehabilitation; Digital health

Outcome Measures

Primary Outcomes (3)

• Feasibility of recruitment and participant retention

  A measure of the recruitment and retention of study participants

  18 months

• Adherence

  adherence to vital sign monitoring during the 6 or 8 week pulmonary rehabilitation trial and the 12 week follow-up period.

  18 months

• Acceptability

  Using a fit for purpose questionnaire to evaluate participant acceptance of the remote patient monitoring system.

  18 months

Secondary Outcomes (8)

• Staffing time and resources

  18 months

• Self-efficacy for managing chronic disease-6 items

  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

• Physical activity levels

  Baseline, post-program, and 12-week follow-up

Study Arms (2)

Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+)

ACTIVE COMPARATOR

6 or 8 weeks BEPR+ program

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

Behavioral: digital Remote Patient Monitoring+BEPR+ (dRPM+)

Interventions

digital Remote Patient Monitoring+BEPR+ (dRPM+) BEHAVIORAL

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.

digital Remote Patient Monitoring + BEPR+ (dRPM+)

Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+) BEHAVIORAL

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.

Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+)

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

G. F. MacDonald Centre for Lung Health

Edmonton, Alberta, T5K 0L5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael K Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 11, 2023
• Study Start: September 28, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)