Chronic Obstructive Pulmonary Disease (COPD)NCT06660589
Feasibility Study of Telerehabilitation for People with Chronic Obstructive Pulmonary Disease in Nuuk
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Steno Diabetes Center Greenland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 15 Feb 2025
- How long will I take part?
- 10 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ten individuals diagnosed with COPD and followed at Queen Ingrid's Hospital in Nuuk, Greenland will be identified through electronic medical records.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Keywords
- Greenland, COPD, telerehabilitation, feasibility
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with COPD | People with COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility criteria: Recruitment
How quickly can we recruit participants? What factors hinder patients from participating? Which methods work best to attract patients?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the intervention at 10 weeks.
Secondary outcomes (4)
Chair Stand Test (CST)
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.
Measured: At enrollment and at the end of the intervention at 10 weeks.
COPD Assessment Test (CAT)
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.
Measured: At enrollment and at the end of the intervention at 10 weeks.
Smoking status
"Do you currently smoke cigarettes?" (Yes/No) "How many cigarettes do you smoke per day?"
Measured: At enrollment and at the end of the intervention at 10 weeks.
Physical activity
measured by number of daily steps
Measured: At enrollment and at the end of the intervention at 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 10 participants (estimated)
- Target duration
- 10 Weeks
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Greenland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660589
- Sponsor's protocol ID
- 2024-20410
- Other IDs
- NNF20SA0064190
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Telerehabilitation for People with Chronic Obstructive Pulmonary Disease in Nuuk: Evaluation and Adaptations for Future Rollout Across Greenland
- ClinicalTrials.gov ID
- NCT06660589
- Acronym / sponsor ID
- 2024-20410
- Keywords
- Greenland, COPD, telerehabilitation, feasibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Steno Diabetes Center GreenlandUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with COPD | – | –People with COPD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ten individuals diagnosed with COPD and followed at Queen Ingrid's Hospital in Nuuk, Greenland will be identified through electronic medical records.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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?
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.
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.
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.
4 secondary outcomes
Chair Stand Test (CST)
Time frame: 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.
Smoking status
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Steno Diabetes Center Greenland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maja Hykkelbjerg Nielsen (+299250639, mjni@peqqik.gl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility criteria: Recruitment (time frame: From enrollment to the end of the intervention at 10 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.