Actively Recruiting

Phase Not Applicable
Age: 35Years - 80Years
All Genders
NCT06401512

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

Led by Western Norway University of Applied Sciences · Updated on 2025-01-23

80

Participants Needed

1

Research Sites

134 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 35Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with COPD and living at home
  • Post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) below the lower limit of normality
Not Eligible

You will not qualify if you...

  • Severe somatic disease
  • Severe psychiatric diagnosis
  • Unable to provide informed consent
  • Cannot write, speak, or understand Norwegian

AI-Screening

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Trial Site Locations

Total: 1 location

1

Western Norway University of Applied Sciences

Bergen, Norway, Norway, 5063

Actively Recruiting

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Research Team

B

Beate-Christin H Kolltveit, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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