COPD Chronic Obstructive Pulmonary DiseaseNCT06401512
Digital Follow-up Program for People with Chronic Obstructive Pulmonary Disease in Primary Healthcare
A study testing Guided self-determination (GSD) follow-up approach by primary care nurses. in people with COPD Chronic Obstructive Pulmonary Disease, run by Western Norway University of Applied Sciences at 1 site in Norway.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD), characterized by non-reversible airflow obstruction, contributes to high mortality and morbidity rates worldwide, including Norway. Individuals with COPD experience symptoms and complications that impede daily activities and diminish their quality of life. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- COPD Chronic Obstructive Pulmonary Disease
- What is being tested?
- Guided self-determination (GSD) follow-up approach by primary care nurses.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 2 May 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD living at home
- Post-bronchodilator forced expiratory volume 1 s (FEV1) to forced vital capacity (FVC) below lower limit of normality
Who cannot join
- Severe somatic disease
- Severe psychiatric diagnosis
- Not able to provide informed consent
- Do not write, speak or understand Norwegian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Western Norway University of Applied Sciences
Bergen, Norway, 5063
Beate-Christin H Kolltveit, 0047 41206108, beate-christin.hope.kolltveit@hvl.no
About this study
Official title: A Guided Self-determination Follow-up Program Delivered Within a Digital Platform for People with Chronic Obstructive Pulmonary Disease in Primary Care
Chronic Obstructive Pulmonary Disease (COPD), characterized by non-reversible airflow obstruction, contributes to high mortality and morbidity rates worldwide, including Norway. Individuals with COPD experience symptoms and complications that impede daily activities and diminish their quality of life. COPD places a growing burden on healthcare systems presently and in the future. Interventions to empower individuals to self-manage their health effectively are needed to help the challenges of living with COPD, and work towards a sustainable healthcare system. As part of the broader healthcare policy agenda, this project aligns with the increasing emphasis on digital homebased primary healthcare. The intervention in this study will combine digital homebased care and guided self-determination follow-ups (GSD) within a general practice setting.
This project consists of 1) explore the feasibility of a COPD specific GSD counselling program delivered within a digital platform in primary care, 2) explore patients' and nurses' experiences applying the program, 3) examine the treatment fidelity of the intervention amongst healthcare professionals.
Read more
This project is a pilot cluster-randomized controlled trial (RCT), including individuals diagnosed with COPD, conducted in primary healthcare settings, and assessment of feasibility and uncertainties before conducting a later full-scale cluster-RCT. The intervention draws upon the Medical Research Council's revised guidelines for developing complex intervention studies, focusing on the initial phases of intervention development and pilot testing. Primary care clinics are randomly assigned into either an intervention- or a control group. The intervention consists of the GSD counselling program with follow-up within a digital platform. The control group provide regular care. The project will include both qualitative (individual semi-structured interviews), and quantitative data (questionnaires and clinical data).
In conclusion, this project explores an innovative intervention offering personalized strategies for COPD management in primary care clinic, by containing a digitalized homebased care program and follow-ups. The study aims to improve the daily living for people with COPD, while contributing to the future sustainability of healthcare systems.
- Being tested
- Guided self-determination (GSD) follow-up approach by primary care nurses.
- Keywords
- COPD, Guided self-determination, Primary healthcare, Randomized controlled trial, Web-based follow-up
- 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.
Guided self-determination (GSD) follow-up approach by primary care nurses.Behavioural
The GSD counseling program consists of four scheduled consultations with a nurse and a digital platform with tools to help people better manage their health. The consultations will be facilitated by using reflection sheets to stimulate written reflection in the context of GSD.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Guided self-determination (GSD) follow-up approach by primary care nurses. |
| Control group | No intervention | Regular follow-up by primary care physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical journal
COPD-related information from medical journal
Measured: Baseline, and 3, 6, 9 and 12 months
Qualitative data
Individual interviews with participants
Measured: 6 - 18 months from baseline
Questionnaire
Health literacy using the Health Literacy Questionnaire (HLQ).
Measured: Baseline, and 3, 6, 9 and 12 months
Questionnaire
Impact of COPD using the COPD assessment test (CAT).
Measured: Baseline, and 3, 6, 9 and 12 months
Questionnaire
Activity-level using International Physical Activity Questionnaire (IPAQ) - Short Form.
Measured: Baseline, and 3, 6, 9 and 12 months
Questionnaire
Exacerbation-related information from patient
Measured: Baseline, and 3, 6, 9 and 12 months
Questionnaire
Patient education and self-management using The Health Education Impact Questionnaire (HeiQ)
Measured: Baseline, and 3, 6, 9 and 12 months
Questionnaire
Medication adherence using The My Experience of Taking Medicines Questionnaire (MyMEDS), adapted patients with COPD.
Measured: Baseline, and 3, 6, 9 and 12 months
Questionnaire
Well-being using Well-Being Index (WHO-5).
Measured: Baseline, and 3, 6, 9 and 12 months
Questionnaire
Self-rated health using EuroQol-5D-5L.
Measured: Baseline, and 3, 6, 9 and 12 months
Questionnaire
Dyspnea using Dyspnea-12 questionnaire.
Measured: Baseline, and 3, 6, 9 and 12 months
Questionnaire
Patient satisfaction using Client Satisfaction Questionnaire (CSQ-8) and Patient global impression of change.
Measured: Baseline, and 3, 6, 9 and 12 months
Weight
Weight in kg
Measured: Baseline and 12 months
Height
Height in cm
Measured: Baseline and 12 months
Recruitment rate for primary care practices
Recruitment for primary care practices will be reported in terms of the number and proportion of primary care practices approached versus the practices that responded and, thereafter, the number who agreed to participate.
Measured: Baseline
Recruitment rate for participants
Participant recruitment will be reported in terms of the number of participants screened, found eligible, contacted, and those who provided written consent. Data for each recruitment step will be collected from all involved practices through self-reported numbers and the signed consent forms. Proportions will also be calculated for the number of participants screened versus those contacted, as well as for those contacted versus those who provided written consent.
Measured: Baseline
Retention rate
Retention will be reported as the number and proportion of participants who remain in the program at a certain timepoint. This will be calculated as the number of participants remaining in the program at each time point versus the number at baseline. To measure the retention rate, data from nurse reports, checklists, and medical records will be utilized.
Measured: Baseline, and 3, 6, 9 and 12 months
Attrition rate
The attrition rate, defined as the number of participants lost to follow-up, will be calculated as 1 minus the retention rate and as the number of participants lost to follow-up between consecutive time points. To measure the attrition rate, data from nurse reports, checklists, and medical records will be utilized. Additionally, data on who exited the program at what step and from whom we lack follow-up data will be collected.
Measured: Baseline, and 3, 6, 9 and 12 months
Adherence rate
Adherence rate will be collected in terms of number of sessions attended by each participant. To measure the adherence rate checklists and medical journals filled out by nurses conducting the intervention and self-reported data will be used.
Measured: Baseline, and 3, 6, and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start2 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPD Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beate-Christin Hope Kolltveit, Western Norway University of Applied Sciences
- Investigators
- Beate-Christin H Kolltveit, Ph.D., Principal investigator, Western Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401512
- Sponsor's protocol ID
- 656382
- Status last verified
- Jan 2025
- First submitted
- 23 Apr 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial.
Publications
Kolltveit BH, Graue M, Borge CR, Frisk B. Patients' experiences with participating in a team-based person-centred intervention for patients at risk of or diagnosed with COPD in general practice. Pilot Feasibility Stud. 2023 Sep 25;9(1):164. doi: 10.1186/s40814-023-01398-9.
PubMed 37749601Kvidaland HK, Iversen MM, Frisk B, Richards DA, Lomborg K, Borge CR, Kolltveit BH. Recruitment for a digitally based follow-up program for people with chronic obstructive pulmonary disease: a pilot cluster randomized controlled trial. Pilot Feasibility Stud. 2026 May 9;12(1):91. doi: 10.1186/s40814-026-01832-8.
PubMed 42106871
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Guided Self-determination Follow-up Program Delivered Within a Digital Platform for People with Chronic Obstructive Pulmonary Disease in Primary Care
- ClinicalTrials.gov ID
- NCT06401512
- Acronym / sponsor ID
- 656382
- Keywords
- COPD, Guided self-determination, Primary healthcare, Randomized controlled trial, Web-based follow-up
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Western Norway University of Applied SciencesUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 May 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 (COPD), characterized by non-reversible airflow obstruction, contributes to high mortality and morbidity rates worldwide, including Norway. Individuals with COPD experience symptoms and complications that impede daily activities and diminish their quality of life. COPD places a growing burden on healthcare systems presently and in the future. Interventions to empower individuals to self-manage their health effectively are needed to help the challenges of living with COPD, and work towards a sustainable healthcare system. As part of the broader healthcare policy agenda, this project aligns with the increasing emphasis on digital homebased primary healthcare. The intervention in this study will combine digital homebased care and guided self-determination follow-ups (GSD) within a general practice setting.
This project consists of 1) explore the feasibility of a COPD specific GSD counselling program delivered within a digital platform in primary care, 2) explore patients' and nurses' experiences applying the program, 3) examine the treatment fidelity of the intervention amongst healthcare professionals.
This project is a pilot cluster-randomized controlled trial (RCT), including individuals diagnosed with COPD, conducted in primary healthcare settings, and assessment of feasibility and uncertainties before conducting a later full-scale cluster-RCT. The intervention draws upon the Medical Research Council's revised guidelines for developing complex intervention studies, focusing on the initial phases of intervention development and pilot testing. Primary care clinics are randomly assigned into either an intervention- or a control group. The intervention consists of the GSD counselling program with follow-up within a digital platform. The control group provide regular care. The project will include both qualitative (individual semi-structured interviews), and quantitative data (questionnaires and clinical data).
In conclusion, this project explores an innovative intervention offering personalized strategies for COPD management in primary care clinic, by containing a digitalized homebased care program and follow-ups. The study aims to improve the daily living for people with COPD, while contributing to the future sustainability of healthcare systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Guided self-determination (GSD) follow-up approach by primary care nurses. |
| Control group | No intervention | –Regular follow-up by primary care physician. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with COPD living at home
- Post-bronchodilator forced expiratory volume 1 s (FEV1) to forced vital capacity (FVC) below lower limit of normality
Key exclusion criteria (4 listed)
- Severe somatic disease
- Severe psychiatric diagnosis
- Not able to provide informed consent
- Do not write, speak or understand Norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided self-determination (GSD) follow-up approach by primary care nurses.The GSD counseling program consists of four scheduled consultations with a nurse and a digital platform with tools to help people better manage their health. The consultations will be facilitated by using reflection sheets to stimulate written reflection in the context of GSD. | Behavioural | Intervention group |
Primary outcome
Medical journal
Time frame: Baseline, and 3, 6, 9 and 12 months
COPD-related information from medical journal
Qualitative data
Time frame: 6 - 18 months from baseline
Individual interviews with participants
Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Health literacy using the Health Literacy Questionnaire (HLQ).
Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Impact of COPD using the COPD assessment test (CAT).
Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Activity-level using International Physical Activity Questionnaire (IPAQ) - Short Form.
Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Exacerbation-related information from patient
Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Patient education and self-management using The Health Education Impact Questionnaire (HeiQ)
Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Medication adherence using The My Experience of Taking Medicines Questionnaire (MyMEDS), adapted patients with COPD.
Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Well-being using Well-Being Index (WHO-5).
Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Self-rated health using EuroQol-5D-5L.
Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Dyspnea using Dyspnea-12 questionnaire.
Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Patient satisfaction using Client Satisfaction Questionnaire (CSQ-8) and Patient global impression of change.
Weight
Time frame: Baseline and 12 months
Weight in kg
Height
Time frame: Baseline and 12 months
Height in cm
Recruitment rate for primary care practices
Time frame: Baseline
Recruitment for primary care practices will be reported in terms of the number and proportion of primary care practices approached versus the practices that responded and, thereafter, the number who agreed to participate.
Recruitment rate for participants
Time frame: Baseline
Participant recruitment will be reported in terms of the number of participants screened, found eligible, contacted, and those who provided written consent. Data for each recruitment step will be collected from all involved practices through self-reported numbers and the signed consent forms. Proportions will also be calculated for the number of participants screened versus those contacted, as well as for those contacted versus those who provided written consent.
Retention rate
Time frame: Baseline, and 3, 6, 9 and 12 months
Retention will be reported as the number and proportion of participants who remain in the program at a certain timepoint. This will be calculated as the number of participants remaining in the program at each time point versus the number at baseline. To measure the retention rate, data from nurse reports, checklists, and medical records will be utilized.
Attrition rate
Time frame: Baseline, and 3, 6, 9 and 12 months
The attrition rate, defined as the number of participants lost to follow-up, will be calculated as 1 minus the retention rate and as the number of participants lost to follow-up between consecutive time points. To measure the attrition rate, data from nurse reports, checklists, and medical records will be utilized. Additionally, data on who exited the program at what step and from whom we lack follow-up data will be collected.
Adherence rate
Time frame: Baseline, and 3, 6, and 9 months.
Adherence rate will be collected in terms of number of sessions attended by each participant. To measure the adherence rate checklists and medical journals filled out by nurses conducting the intervention and self-reported data will be used.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Background: PubMed 37749601Kolltveit BH, Graue M, Borge CR, Frisk B. Patients' experiences with participating in a team-based person-centred intervention for patients at risk of or diagnosed with COPD in general practice. Pilot Feasibility Stud. 2023 Sep 25;9(1):164. doi: 10.1186/s40814-023-01398-9.
- Derived from this study: PubMed 42106871Kvidaland HK, Iversen MM, Frisk B, Richards DA, Lomborg K, Borge CR, Kolltveit BH. Recruitment for a digitally based follow-up program for people with chronic obstructive pulmonary disease: a pilot cluster randomized controlled trial. Pilot Feasibility Stud. 2026 May 9;12(1):91. doi: 10.1186/s40814-026-01832-8.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial.
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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.
Beate-Christin H Kolltveit, Ph.D. principal investigator
Western Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided self-determination (GSD) follow-up approach by primary care nurses. in people with COPD Chronic Obstructive Pulmonary Disease, run by Western Norway University of Applied Sciences at 1 site in Norway.
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 2 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: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beate-Christin H Kolltveit, Ph.D. (+47 41206108, beate-christin.hope.kolltveit@hvl.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical journal (time frame: Baseline, and 3, 6, 9 and 12 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401512, which also lists 2 linked publications.
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 23 Jan 2025.