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Behavioral Intervention

Digital Remote Patient Monitoring for COPD

Q: Does the eligibility criteria for this research encompass individuals aged 85 and above?

Eligibility for this trial requires participants to be between the ages of 30 and 100.

Q: Is participation in this medical research available to me?

Eligible candidates for this trial must be between 30 and 100 years old, have chronic obstructive pulmonary disease, and there is a maximum of 74 openings.

Q: How many participants are being accepted into this research study?

Affirmative. According to the information located on clinicaltrials.gov, this medical experiment is currently enlisting participants; it was uploaded on August 29th 2023 and adjusted most recently on October 5th of last year. 74 individuals are being sought out at a single centre for recruitment purposes.

Q: Is this trial currently open for enrollment?

Affirmative. Currently, clinicaltrials.gov is hosting information about this medical trial which was initiated on August 29th 2023 and revised October 5th 2023. <a href="https://www.withpower.com/clinical-trials/all">All</a> in all, 74 patients are being recruited from one site.

Q: What are the underlying aims of this medical trial?

This trial will span approximately 18 months and its primary outcome is to determine the patient's adherence. There are also two secondary outcomes: a 6-item generic tool measuring confidence in managing chronic illnesses, as well as questionnaires gauging self-management knowledge &#x26; behaviours of those with chronic diseases. Additionally, there is an 9-point scale that aims to discern how confident patients feel about exercising 3 times weekly despite various situations (e.g., bad weather).

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Adherence

Feasibility of recruitment and participant retention

Secondary outcome measures

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,103 Total Patients Enrolled

Michael K Stickland, PhDPrincipal InvestigatorUniversity of Alberta

9 Previous Clinical Trials

4,469 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this research encompass individuals aged 85 and above?

"Eligibility for this trial requires participants to be between the ages of 30 and 100."

Answered by AI

Is participation in this medical research available to me?

"Eligible candidates for this trial must be between 30 and 100 years old, have chronic obstructive pulmonary disease, and there is a maximum of 74 openings."

Answered by AI

How many participants are being accepted into this research study?

"Affirmative. According to the information located on clinicaltrials.gov, this medical experiment is currently enlisting participants; it was uploaded on August 29th 2023 and adjusted most recently on October 5th of last year. 74 individuals are being sought out at a single centre for recruitment purposes."

Answered by AI

Is this trial currently open for enrollment?

"Affirmative. Currently, clinicaltrials.gov is hosting information about this medical trial which was initiated on August 29th 2023 and revised October 5th 2023. All in all, 74 patients are being recruited from one site."

Answered by AI

What are the underlying aims of this medical trial?

"This trial will span approximately 18 months and its primary outcome is to determine the patient's adherence. There are also two secondary outcomes: a 6-item generic tool measuring confidence in managing chronic illnesses, as well as questionnaires gauging self-management knowledge & behaviours of those with chronic diseases. Additionally, there is an 9-point scale that aims to discern how confident patients feel about exercising 3 times weekly despite various situations (e.g., bad weather)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhanced Pulmonary Rehabilitation With Digital Remote Home Monitoring

Michael Stickland 2023. "Enhanced Pulmonary Rehabilitation With Digital Remote Home Monitoring". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077994.