Clinical trial NCT06660589: Feasibility Study of Telerehabilitation for People with Chronic Obstructive Pulmonary Disease in Nuuk
Official title: Feasibility Study of Telerehabilitation for People with Chronic Obstructive Pulmonary Disease in Nuuk: Evaluation and Adaptations for Future Rollout Across Greenland
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Greenland
COPD
telerehabilitation
feasibility
Lead sponsor: Steno Diabetes Center Greenland
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility criteria: Recruitment
timeFrame: From enrollment to the end of the intervention at 10 weeks.
measure: Feasibility criteria: Adherence
timeFrame: From enrollment to the end of the intervention at 10 weeks.
measure: Feasibility criteria: Acceptability
timeFrame: From enrollment to the end of the intervention at 10 weeks.
measure: Feasibility criteria: Technical challenges
timeFrame: From enrollment to the end of the intervention at 10 weeks.
Secondary outcomes:
measure: Chair Stand Test (CST)
timeFrame: At enrollment and at the end of the intervention at 10 weeks.
measure: COPD Assessment Test (CAT)
timeFrame: At enrollment and at the end of the intervention at 10 weeks.
measure: Smoking status
timeFrame: At enrollment and at the end of the intervention at 10 weeks.
measure: Physical activity
timeFrame: At enrollment and at the end of the intervention at 10 weeks.
Other outcomes:
Locations:
Study officials:
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