- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06660589
Feasibility Study of Telerehabilitation for People with Chronic Obstructive Pulmonary Disease in Nuuk
Feasibility Study of Telerehabilitation for People with Chronic Obstructive Pulmonary Disease in Nuuk: Evaluation and Adaptations for Future Rollout Across Greenland
Chronic obstructive pulmonary disease, or COPD, is a major global health issue. It can make people ill, impact their quality of life, and increase their use of healthcare services. In some parts of Greenland, it can be particularly challenging to manage COPD due to the distance to healthcare assistants, nurses, or doctors. Telerehabilitation, which allows people to receive treatment online, could be a good solution.
This project aims to explore how we can best support COPD patients in Nuuk through an online rehabilitation program. The program functions as a pilot study, where we examine how it can be adapted and scaled across Greenland and to patients with other conditions. We will assess how well the program meets patients' needs and determine what adjustments are necessary to improve it.
The study will include 10 individuals with COPD living in Nuuk. They will receive training materials and have an initial meeting with a physiotherapist to set goals. For 10 weeks, they will participate in online training sessions twice a week. Through their feedback, we hope to identify ways to make the program more effective and tailored.
Before the training program begins, participants will have various health metrics measured, complete a questionnaire, and perform a physical test. This will be repeated after the training program is completed to assess any changes in the participants.
We hope that the results will provide insights into improving the treatment of COPD patients and guide necessary adjustments for future rollout across Greenland and to other disease groups. All participants will provide consent for their involvement, and their data will be treated anonymously.
Study Overview
Status
Conditions
Detailed Description
In this study, data will be collected at multiple time points relative to when participants are enrolled:
- Baseline data collection occurs before the intervention begins. Participants will undergo an initial consultation via PUISA, where various assessments (such as the Sit-to-Stand test, CAT score, MRC score, and other health measurements) will be performed. Additionally, participants will fill out a questionnaire and have their physical condition tested.
- Post-intervention data collection occurs after the 10-week training program has concluded. During this final evaluation, the same parameters assessed at baseline (physical condition, CAT questionnaire, etc.) will be measured again. Participants will also provide feedback through qualitative interviews, focusing on their experiences with the program.
Thus, data will be collected both before (pre-intervention) and after (post-intervention) the 10-week telerehabilitation program to evaluate changes and gather feedback.
Sampling method:
The study will employ purposive sampling to select participants who meet specific criteria, such as having a certain level of illness or the ability to participate in a telerehabilitation program. Sampling will be conducted based on age, sex, and degree of illness to ensure a well-defined and relevant participant group.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maja Hykkelbjerg Nielsen
- Phone Number: +299250639
- Email: mjni@peqqik.gl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Residing in Nuuk
- Has access to a computer/phone and the internet
- Understands Danish and can participate in a Danish dialogue
- Motivated to participate in online training
- Post-bronchodilator FEV1/FVC ratio below 0.7, and FEV1 below 80% of predicted value
- MRC score of 2 or higher
Exclusion Criteria:
- Unstable angina pectoris
- Hemodynamically significant aortic stenosis
- Physical or psychological condition that prevents benefit from a video consultation, e.g., deafness, muteness, or blindness
- Exacerbation within 6 weeks, lung infection, or other factors that affect the results of a lung function test
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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People with COPD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility criteria: Recruitment
Time Frame: From enrollment to the end of the intervention at 10 weeks.
|
How quickly can we recruit participants?
What factors hinder patients from participating?
Which methods work best to attract patients?
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From enrollment to the end of the intervention at 10 weeks.
|
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Feasibility criteria: Adherence
Time Frame: From enrollment to the end of the intervention at 10 weeks.
|
Active participation will be assessed through attendance rates in the twice-weekly online sessions and adherence to the weekly self-guided session.
Motivation and involvement will be gauged by tracking whether participants maintain consistent engagement or drop off over time.
Completion of the full 10-week telerehabilitation program will serve as a key indicator of sustained involvement.
No-shows and attendance will also be closely monitored.
|
From enrollment to the end of the intervention at 10 weeks.
|
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Feasibility criteria: Acceptability
Time Frame: From enrollment to the end of the intervention at 10 weeks.
|
Participants will be asked about their experiences with the video consultation app and other digital tools.
They will also provide feedback on the relevance of the telerehabilitation program content in relation to their expectations and needs.
Key questions will assess whether participants understood the material and how the technology and content could be improved for better engagement and effectiveness.
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From enrollment to the end of the intervention at 10 weeks.
|
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Feasibility criteria: Technical challenges
Time Frame: From enrollment to the end of the intervention at 10 weeks.
|
Participants will be asked about the quality of their internet connection during sessions, focusing on whether they had reliable access to high-speed internet.
They will also assess the functionality of the video consultation app and other digital tools, providing insights into usability and ease of navigation.
The study will evaluate any challenges participants faced related to the devices they used for the program.
Additionally, participants will provide feedback on the audio and video quality during sessions, noting any issues that may have impacted communication and engagement.
|
From enrollment to the end of the intervention at 10 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chair Stand Test (CST)
Time Frame: At enrollment and at the end of the intervention at 10 weeks.
|
The CST is designed to assess an individual's ability to perform sit-to-stand movements, which are essential for daily activities such as getting up from a chair, rising from a bed, and maintaining independence.
|
At enrollment and at the end of the intervention at 10 weeks.
|
|
COPD Assessment Test (CAT)
Time Frame: At enrollment and at the end of the intervention at 10 weeks.
|
The CAT is used to evaluate the severity of COPD symptoms and their effect on the patient's health status and quality of life.
It helps healthcare professionals monitor disease progression and the effectiveness of treatment interventions.
|
At enrollment and at the end of the intervention at 10 weeks.
|
|
Smoking status
Time Frame: At enrollment and at the end of the intervention at 10 weeks.
|
"Do you currently smoke cigarettes?" (Yes/No) "How many cigarettes do you smoke per day?"
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At enrollment and at the end of the intervention at 10 weeks.
|
|
Physical activity
Time Frame: At enrollment and at the end of the intervention at 10 weeks.
|
measured by number of daily steps
|
At enrollment and at the end of the intervention at 10 weeks.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-20410
- NNF20SA0064190 (Other Grant/Funding Number: Novo Nordisk Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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