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NCT Number: NCT06660589

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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?

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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?"

  4. Physical activity

    Time frame: At enrollment and at the end of the intervention at 10 weeks.

    measured by number of daily steps

Study contacts

Contact information is provided by the study sponsor or research team.

Maja Hykkelbjerg Nielsen

CONTACT

[email protected]

+299250639

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Greenland

Other

Registry information

Official study title

Feasibility Study of Telerehabilitation for People with Chronic Obstructive Pulmonary Disease in Nuuk: Evaluation and Adaptations for Future Rollout Across Greenland

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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