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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Guided self-determination (GSD) follow-up approach by primary care nurses.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beate-Christin H Kolltveit, Ph.D.; Phone Number: +47 41206108; Email: beate-christin.hope.kolltveit@hvl.no

Study Locations

• Norway
  • Bergen, Norway, 5063
    • Recruiting
    • Western Norway University of Applied Sciences
    • Contact: Beate-Christin H Kolltveit; Phone Number: 0047 41206108; Email: beate-christin.hope.kolltveit@hvl.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	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.
No Intervention: Control group; Regular follow-up by primary care physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical journal	COPD-related information from medical journal	Baseline, and 3, 6, 9 and 12 months
Qualitative data	Individual interviews with participants	6 - 18 months from baseline
Questionnaire	Health literacy using the Health Literacy Questionnaire (HLQ).	Baseline, and 3, 6, 9 and 12 months
Questionnaire	Impact of COPD using the COPD assessment test (CAT).	Baseline, and 3, 6, 9 and 12 months
Questionnaire	Activity-level using International Physical Activity Questionnaire (IPAQ) - Short Form.	Baseline, and 3, 6, 9 and 12 months
Questionnaire	Exacerbation-related information from patient	Baseline, and 3, 6, 9 and 12 months
Questionnaire	Patient education and self-management using The Health Education Impact Questionnaire (HeiQ)	Baseline, and 3, 6, 9 and 12 months
Questionnaire	Medication adherence using The My Experience of Taking Medicines Questionnaire (MyMEDS), adapted patients with COPD.	Baseline, and 3, 6, 9 and 12 months
Questionnaire	Well-being using Well-Being Index (WHO-5).	Baseline, and 3, 6, 9 and 12 months
Questionnaire	Self-rated health using EuroQol-5D-5L.	Baseline, and 3, 6, 9 and 12 months
Questionnaire	Dyspnea using Dyspnea-12 questionnaire.	Baseline, and 3, 6, 9 and 12 months
Questionnaire	Patient satisfaction using Client Satisfaction Questionnaire (CSQ-8) and Patient global impression of change.	Baseline, and 3, 6, 9 and 12 months
Weight	Weight in kg	Baseline and 12 months
Height	Height in cm	Baseline and 12 months
Recruitment rate for primary care practices	Recruitment for primary care practices will be reported in terms of the number and proportion of primary care practices approached versus the practices that responded and, thereafter, the number who agreed to participate.	Baseline
Recruitment rate for participants	Participant recruitment will be reported in terms of the number of participants screened, found eligible, contacted, and those who provided written consent. Data for each recruitment step will be collected from all involved practices through self-reported numbers and the signed consent forms. Proportions will also be calculated for the number of participants screened versus those contacted, as well as for those contacted versus those who provided written consent.	Baseline
Retention rate	Retention will be reported as the number and proportion of participants who remain in the program at a certain timepoint. This will be calculated as the number of participants remaining in the program at each time point versus the number at baseline. To measure the retention rate, data from nurse reports, checklists, and medical records will be utilized.	Baseline, and 3, 6, 9 and 12 months
Attrition rate	The attrition rate, defined as the number of participants lost to follow-up, will be calculated as 1 minus the retention rate and as the number of participants lost to follow-up between consecutive time points. To measure the attrition rate, data from nurse reports, checklists, and medical records will be utilized. Additionally, data on who exited the program at what step and from whom we lack follow-up data will be collected.	Baseline, and 3, 6, 9 and 12 months
Adherence rate	Adherence rate will be collected in terms of number of sessions attended by each participant. To measure the adherence rate checklists and medical journals filled out by nurses conducting the intervention and self-reported data will be used.	Baseline, and 3, 6, and 9 months.

Collaborators and Investigators

• Sponsor: Western Norway University of Applied Sciences
• Investigators: Principal Investigator: Beate-Christin H Kolltveit, Ph.D., Western Norway University of Applied Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Randomized controlled trial; Primary healthcare; Guided self-determination; Web-based follow-up
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 656382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial.
• IPD Sharing Time Frame: Data will be available two years after publication.
• IPD Sharing Access Criteria: In accordance with the approvals granted for this study by the Regional Committee on Medical Research Ethics and the Norwegian Data Inspectorate, the data files will be stored securely and in accordance with the Norwegian Law of Privacy Protection. A subset of the data file with anonymized data will be made available to interested researchers upon reasonable request to Beate-Christin Hope Kolltveit: beate-christin.hope.kolltveit@hvl.no, providing that Norwegian privacy legislation and the General Data Protection Regulation are respected, and that permission is granted from the Norwegian Data Inspectorate and the data protection officer at Western Norway University of Applied Sciences.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No