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Behavioral Intervention

Digital Remote Patient Monitoring for COPD

N/A
Recruiting
Led By Michael K Stickland, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Summary

This trial assesses whether remote patient monitoring improved outcomes for COPD patients. Secondary outcomes include clinical measures such as quality of life, physical activity and self-efficacy.

Who is the study for?
This trial is for individuals enrolled in pulmonary rehabilitation at the G.F. MacDonald Centre with confirmed COPD (FEV1/FVC ratio < 0.7). Participants must be able to read and communicate in English, willing to use digital devices, ambulatory, and not have unstable cardiovascular disease or cognitive impairments that affect questionnaire accuracy.
What is being tested?
The study is testing if adding digital remote patient monitoring (dRPM) to an enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+) improves outcomes like functional capacity, health status, quality of life, self-management skills and physical activity compared to BEPR+ alone.
What are the potential side effects?
Since this trial focuses on rehabilitation programs and monitoring rather than medication or invasive procedures, side effects are minimal but may include discomfort from using technology or fatigue related to increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am enrolled in a lung rehab program at G.F. MacDonald Centre for my COPD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I can accurately complete questionnaires despite any cognitive impairments.
Select...
I can walk on my own and do not have heart problems that change rapidly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability
Adherence
Feasibility of recruitment and participant retention
Secondary study objectives
Functional exercise capacity assessed by the 6-minute walk test
General health related quality of life as assessed by the EuroQol 5 dimensions 5 level (EQ5D5L) questionnaire.
Health status as assessed by the COPD Assessment Tool
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: digital Remote Patient Monitoring + BEPR+ (dRPM+)Experimental Treatment1 Intervention
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
Group II: Enhanced Breathe Easy Pulmonary Rehabilitation Program (BEPR+)Active Control1 Intervention
6 or 8 weeks BEPR+ program

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
913 Previous Clinical Trials
390,359 Total Patients Enrolled
Michael K Stickland, PhDPrincipal InvestigatorUniversity of Alberta
9 Previous Clinical Trials
4,350 Total Patients Enrolled
~0 spots leftby Oct 2024
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