Feasibility Study of Telerehabilitation for People with Chronic Obstructive Pulmonary Disease in Nuuk

October 24, 2024 updated by: Steno Diabetes Center Greenland

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

Not yet recruiting

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

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maja Hykkelbjerg Nielsen
  • Phone Number: +299250639
  • Email: mjni@peqqik.gl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ten individuals diagnosed with COPD and followed at Queen Ingrid's Hospital in Nuuk, Greenland will be identified through electronic medical records.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
People with COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
From enrollment to the end of the intervention at 10 weeks.
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.
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.
From enrollment to the end of the intervention at 10 weeks.
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?"
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

February 15, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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