Clinical trial NCT06401512: Digital Follow-up Program for People with Chronic Obstructive Pulmonary Disease in Primary Healthcare
Official title: A Guided Self-determination Follow-up Program Delivered Within a Digital Platform for People with Chronic Obstructive Pulmonary Disease in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD Chronic Obstructive Pulmonary Disease
Keywords: COPD
Guided self-determination
Primary healthcare
Randomized controlled trial
Web-based follow-up
Lead sponsor: Western Norway University of Applied Sciences
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Medical journal
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Qualitative data
timeFrame: 6 - 18 months from baseline
measure: Questionnaire
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Questionnaire
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Questionnaire
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Questionnaire
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Questionnaire
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Questionnaire
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Questionnaire
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Questionnaire
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Questionnaire
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Questionnaire
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Weight
timeFrame: Baseline and 12 months
measure: Height
timeFrame: Baseline and 12 months
measure: Recruitment rate for primary care practices
timeFrame: Baseline
measure: Recruitment rate for participants
timeFrame: Baseline
measure: Retention rate
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Attrition rate
timeFrame: Baseline, and 3, 6, 9 and 12 months
measure: Adherence rate
timeFrame: Baseline, and 3, 6, and 9 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Western Norway University of Applied Sciences
Study officials:
affiliation: Western Norway University of Applied Sciences
name: Beate-Christin H Kolltveit, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.