Clinical trial NCT06850961: A Digital Health Intervention to Promote Self-management in Patients With Chronic Obstructive Pulmonary Disease
Official title: A Digital Health Intervention for Promoting Self-management in Patients With Chronic Obstructive Pulmonary Disease - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Self-management
Mobile Application
Feasibility Studies
Keywords: COPD
Digital health intervention
Feasibility
Self-management
Mobile Application
Lead sponsor: Western Norway University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Helse Forde
First posted: 2025-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will use the mobile app "Pust Deg Bedre" to explore the feasibility and experiences of providing PDB for patients with COPD,
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Recruitment rate
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Intervention adherence
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Adverse events
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Dropout rate
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health related outcomes
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health related outcomes
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health related outcomes
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health related outcomes
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health related outcome
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health related outcome
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health related outcomes
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health related outcomes
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Physical functioning
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Exacerbations, hospital admissions and use of healthcare services
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health literacy
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health literacy
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Health education and self-management
timeFrame: From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Satisfaction with treatment
timeFrame: End of treatment at 8 weeks and the end of treatment at 6-month follow-up
measure: Satisfaction with treatment
timeFrame: End of treatment at 8 weeks and the end of treatment at 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Western Norway University of Applied Sciences
Study officials:
affiliation: Western Norway University of Applied Sciences
name: Bente Frisk, PHD
role: PRINCIPAL_INVESTIGATOR
References: