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

NCT ID: NCT06401512

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2026-12-31

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.

Conditions

COPD Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

Guided self-determination (GSD) follow-up approach by primary care nurses.

Intervention Type: BEHAVIORAL

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.

Control group

Regular follow-up by primary care physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Norway University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Beate-Christin Hope Kolltveit

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beate-Christin H Kolltveit, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Western Norway University of Applied Sciences

Locations

Western Norway University of Applied Sciences

Bergen, Norway, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Beate-Christin H Kolltveit, Ph.D.

Role: CONTACT

beate-christin.hope.kolltveit@hvl.no

+47 41206108

Facility Contacts

Beate-Christin H Kolltveit

Role: primary

beate-christin.hope.kolltveit@hvl.no

0047 41206108

References

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.

Reference Type: BACKGROUND

PMID: 37749601 (View on PubMed)

Other Identifiers

656382

Identifier Type: -

Identifier Source: org_study_id