NCT06660589

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 24, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

GreenlandCOPDtelerehabilitationfeasibility

Outcome Measures

Primary Outcomes (4)

  • Feasibility criteria: Recruitment

    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

    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

    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

    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 Outcomes (4)

  • Chair Stand Test (CST)

    At enrollment and at the end of the intervention at 10 weeks.

  • COPD Assessment Test (CAT)

    At enrollment and at the end of the intervention at 10 weeks.

  • Smoking status

    At enrollment and at the end of the intervention at 10 weeks.

  • Physical activity

    At enrollment and at the end of the intervention at 10 weeks.

Study Arms (1)

People with COPD

People with COPD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Maja Hykkelbjerg Nielsen

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
10 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 28, 2024

Study Start

November 1, 2024

Primary Completion

January 31, 2025

Study Completion

February 15, 2025

Last Updated

October 28, 2024

Record last verified: 2024-10