NCT06401512

Digital Follow-up Program for People With Chronic Obstructive Pulmonary Disease in Primary Healthcare

A Guided Self-determination Follow-up Program Delivered Within a Digital Platform for People With Chronic Obstructive Pulmonary Disease in Primary Care
Western Norway University of Applied Sciences·ClinicalTrials.gov·behavioralRecruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
Guided self-determination (GSD) follow-up approach by primary care nurses.
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Western Norway University of Applied Sciences
Location
Bergen, Norway
Timeline & enrollment
Phase
N/A
Start date
May 02, 2024
End date
Dec 01, 2026
Enrollment
80 participants
Primary outcome

Medical journal,Qualitative data,Questionnaire,Questionnaire,Questionnaire,Questionnaire,Questionnaire,Questionnaire,Questionnaire,Questionnaire,Questionnaire,Questionnaire,Weight,Height

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.

ICD-10 classifications
Other chronic obstructive pulmonary diseaseOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease, unspecifiedChronic obstructive pulmonary disease with acute exacerbation, unspecifiedChronic obstructive pulmonary disease with acute lower respiratory infection
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06401512
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06401512 through Pure Global AI's free database. This phase not specified trial is sponsored by Western Norway University of Applied Sciences and is currently Recruiting. The study focuses on COPD Chronic Obstructive Pulmonary Disease. Target enrollment is 80 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.