A Digital Health Intervention to Promote Self-management in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT06850961

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2030-12-31

Brief Summary

Dyspnea, cough, and chronic mucus hypersecretion are common symptoms in patients with Chronic Obstructive Pulmonary Disease (COPD), which increases risk of infections followed by exacerbations, often leading to hospitalization, disease progression and mortality. This patient group requires lifelong treatment in healthcare. A mobile application was developed to facilitate adherence to evidence-based guidelines for tailored breathing and airway clearance techniques to enhance self-management. The app is only in Norwegian and has a Norwegian name which is "Pust Deg Bedre" (PDB). The PDB app is fully developed and tested and can be downloaded for free. The app seems promising as a treatment tool, but has not yet been clinical evaluated. This project aims to 1) explore the feasibility of providing the app for patients with COPD, 2) explore the patients' with COPD experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 3) explore the physiotherapists' experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 4) explore the physiotherapists' experiences with implementing the PDB-app in treatment of patients with COPD, 5) explore the patients' experiences with the education in use of the PDB-app, and 6) At a 6-month follow up: explore the physiotherapists experiences with the usefulness and applicability of PBD-app, and to generally explore their experiences with participating in the project.

Detailed Description

This project is designed to explore aspects of acceptability and possible uncertainties associated with implementing the PDB-app as part of self-management in patients with COPD. Both quantitative and qualitative data will be collected and analysed.

50-60 patients with COPD and 15-30 physiotherapists in primary health care will be recruited.

A feasibility study will be conducted and evaluated after 8-week intervention and at 6-month follow-up, using a pre-post design.

Intervention: The physiotherapists will be responsible for providing the patients with training on the use of the PDB-app. Based on clinical assessment, the patients will receive a tailored treatment plan within the app. Patients are expected to engage with the tailored PDB-treatment for 8 weeks with follow-up after 6 months. If necessarily, adjustments to the treatment plan will be made throughout the intervention period. Follow-up of patients will occur digitally and physically.

A qualitative interview study will be conducted with semi-structured interviews after 8 weeks of intervention for a deeper understanding of the patients' and physiotherapists' experiences with the PDB-app. Separate focus groups will be conducted with the patients and the physiotherapists.

The investigators will also conduct video-recorded physiotherapy sessions at two time points during the intervention. The first one during the initial session, and then again between 3 to 6 weeks during the 8-week intervention. Subsequently, in-depth interviews, using Interpersonal Process Recall (IPR), will be conducted, with the researcher and physiotherapist, and with the researcher and patient. By using IPR interviews, video-assisted recall will help research participants access underlying experiences of their recent clinical interactions and put them into words. This means that the interaction between patient, physiotherapist and the PDB-app, experienced and recalled in the interview, relates to concrete events of the specific session.

Targeting physiotherapists, the investigators aim to do a long-term follow up 6 months after the intervention and explore their experiences with having participated in IPR interviews and as participants in the study in general. How and to what degree has the IPR interview sessions and the experiences from participating in this project impacted on their clinical practice, perception of role, identity and lifeworld? The investigators will conduct individual semi-structured qualitative interviews with all the physiotherapists from the IPR interviews.

Criteria for success:

• At least 80% of the patients complete the intervention and the questionnaires after 8-weeks
• At least 80% of the patients' complete questionnaires at 6-month follow-up
• At least 90% of physiotherapists complete the study period
• No adverse events by using the PDB-app
• Patient satisfaction score measured with CSQ-8 ≥20 (indicate good satisfaction)

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Self-management; Mobile Application; Feasibility Studies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Digital health intervention group

Patients with COPD will use the mobile-app in self-management of treating dyspnea and mucus secretion.

Group Type: EXPERIMENTAL

Digital health intervention by using a mobile application

Intervention Type: DEVICE

A digital health intervention for promoting self-management in patients with COPD by using a mobile application.

Feasibilty study and qualitative interview studies

Intervention Type: OTHER

This study is a one group feasibility study including quantitative and qualitative study designs. The investigators will use focus groups and indiviual interviews, as well as Interpersonal Process Recall (IPR) interviews.

Interventions

Digital health intervention by using a mobile application

A digital health intervention for promoting self-management in patients with COPD by using a mobile application.

Intervention Type: DEVICE

Feasibilty study and qualitative interview studies

This study is a one group feasibility study including quantitative and qualitative study designs. The investigators will use focus groups and indiviual interviews, as well as Interpersonal Process Recall (IPR) interviews.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Chronic Obstructive Pulmonary Disease
• Mucus-related issues ≥3 times per week
• Speak and write Norwegian
• Ability to independently operate a smartphone and/or iPad

Exclusion Criteria

• Severe mental illness
• Substance abuse that hinder participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Forde

OTHER

Sponsor Role: collaborator

Western Norway University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Bente Frisk

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bente Frisk, PHD

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

Bente Frisk, PHD

Role: CONTACT

bente.frisk@hvl.no

0047- 55587143

Siri Dahl Aune, MSc

Role: CONTACT

siri.dahl.aune@hvl.no

0047-46417431

Facility Contacts

Bente Frisk, PHD

Role: primary

bente.frisk@hvl.no

0047-55587143

Siri Dahl Aune, MSc

Role: backup

siri.dahl.aune@hvl.no

0047-46417431

Other Identifiers

REK2024/733856

Identifier Type: OTHER

Identifier Source: secondary_id

REK2024/733856

Identifier Type: -

Identifier Source: org_study_id