Viewing Study NCT06401512



Ignite Creation Date: 2024-05-11 @ 8:30 AM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06401512
Status: RECRUITING
Last Update Posted: 2024-05-06
First Post: 2024-04-23

Brief Title: Digital Follow-up Program for People With Chronic Obstructive Pulmonary Disease in Primary Healthcare
Sponsor: Western Norway University of Applied Sciences
Organization: Western Norway University of Applied Sciences

Study Overview

Official Title: A Guided Self-determination Follow-up Program Delivered Within a Digital Platform for People With Chronic Obstructive Pulmonary Disease in Primary Care
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Councils 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None