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

COPD Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Guided Self-determination Follow-up Program Delivered Within a Digital Platform for People With Chronic Obstructive Pulmonary Disease in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06401512
• Other study ID #: 656382
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Western Norway University of Applied Sciences
• Contact: Beate-Christin H Kolltveit, Ph.D.
• Phone: +47 41206108
• Email: beate-christin.hope.kolltveit[@]hvl.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Norway	Western Norway University of Applied Sciences	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical journal	COPD-related information from medical journal	Baseline, and 3, 6, 9 and 12 months
Primary	Qualitative data	Individual interviews with participants	6 - 18 months from baseline
Primary	Questionnaire	Health literacy using the Health Literacy Questionnaire (HLQ).	Baseline, and 3, 6, 9 and 12 months
Primary	Questionnaire	Impact of COPD using the COPD assessment test (CAT).	Baseline, and 3, 6, 9 and 12 months
Primary	Questionnaire	Activity-level using International Physical Activity Questionnaire (IPAQ) - Short Form.	Baseline, and 3, 6, 9 and 12 months
Primary	Questionnaire	Exacerbation-related information from patient	Baseline, and 3, 6, 9 and 12 months
Primary	Questionnaire	Patient education and self-management using The Health Education Impact Questionnaire (HeiQ)	Baseline, and 3, 6, 9 and 12 months
Primary	Questionnaire	Medication adherence using The My Experience of Taking Medicines Questionnaire (MyMEDS), adapted patients with COPD.	Baseline, and 3, 6, 9 and 12 months
Primary	Questionnaire	Well-being using Well-Being Index (WHO-5).	Baseline, and 3, 6, 9 and 12 months
Primary	Questionnaire	Self-rated health using EuroQol-5D-5L.	Baseline, and 3, 6, 9 and 12 months
Primary	Questionnaire	Dyspnea using Dyspnea-12 questionnaire.	Baseline, and 3, 6, 9 and 12 months
Primary	Questionnaire	Patient satisfaction using Client Satisfaction Questionnaire (CSQ-8) and Patient global impression of change.	Baseline, and 3, 6, 9 and 12 months
Primary	Weight	Weight in kg	Baseline and 12 months
Primary	Height	Height in cm	Baseline and 12 months