NCT06401512 Digital Follow-up Program for People with Chronic Obstructive Pulmonary Disease in Primary Healthcare
| NCT ID | NCT06401512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Western Norway University of Applied Sciences |
| Condition | COPD Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-05-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-05-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with COPD living at home * Post-bronchodilator forced expiratory volume 1 s (FEV1) to forced vital capacity (FVC) below lower limit of normality Exclusion Criteria: * Severe somatic disease * Severe psychiatric diagnosis * Not able to provide informed consent * Do not write, speak or understand Norwegian
Contact & Investigator
Beate-Christin H Kolltveit, Ph.D.
PRINCIPAL INVESTIGATOR
Western Norway University of Applied Sciences
Frequently Asked Questions
Who can join the NCT06401512 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 80 Years, studying COPD Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06401512 currently recruiting?
Yes, NCT06401512 is actively recruiting participants. Contact the research team at beate-christin.hope.kolltveit@hvl.no for enrollment information.
Where is the NCT06401512 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT06401512 clinical trial?
NCT06401512 is sponsored by Western Norway University of Applied Sciences. The principal investigator is Beate-Christin H Kolltveit, Ph.D. at Western Norway University of Applied Sciences. The trial plans to enroll 80 participants.
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