Western Norway University of Applied Sciences
Bergen, Norway, 5063
Location status: Recruiting
Recruiting
NCT Number: NCT06401512
Digital Follow-up Program for People with Chronic Obstructive Pulmonary Disease in Primary Healthcare
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
35 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Guided self-determination (GSD) follow-up approach by primary care nurses.
BehavioralThe 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.
Primary outcomes
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Medical journal
Time frame: Baseline, and 3, 6, 9 and 12 months
COPD-related information from medical journal
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Qualitative data
Time frame: 6 - 18 months from baseline
Individual interviews with participants
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Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Health literacy using the Health Literacy Questionnaire (HLQ).
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Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Impact of COPD using the COPD assessment test (CAT).
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Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Activity-level using International Physical Activity Questionnaire (IPAQ) - Short Form.
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Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Exacerbation-related information from patient
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Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Patient education and self-management using The Health Education Impact Questionnaire (HeiQ)
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Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Medication adherence using The My Experience of Taking Medicines Questionnaire (MyMEDS), adapted patients with COPD.
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Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Well-being using Well-Being Index (WHO-5).
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Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Self-rated health using EuroQol-5D-5L.
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Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Dyspnea using Dyspnea-12 questionnaire.
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Questionnaire
Time frame: Baseline, and 3, 6, 9 and 12 months
Patient satisfaction using Client Satisfaction Questionnaire (CSQ-8) and Patient global impression of change.
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Weight
Time frame: Baseline and 12 months
Weight in kg
-
Height
Time frame: Baseline and 12 months
Height in cm
-
Recruitment rate for primary care practices
Time frame: Baseline
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.
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Recruitment rate for participants
Time frame: Baseline
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.
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Retention rate
Time frame: Baseline, and 3, 6, 9 and 12 months
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.
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Attrition rate
Time frame: Baseline, and 3, 6, 9 and 12 months
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.
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Adherence rate
Time frame: Baseline, and 3, 6, and 9 months.
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Western Norway University of Applied Sciences
Other
Registry information
Official study title
A Guided Self-determination Follow-up Program Delivered Within a Digital Platform for People with Chronic Obstructive Pulmonary Disease in Primary Care
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 6, 2024
- Registry last updated
- Jan 23, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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