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

A Digital Health Intervention for Promoting Self-management in Patients With Chronic Obstructive Pulmonary Disease - a Feasibility Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06850961
Enrollment
90
Registered
2025-02-28
Start date
2025-01-06
Completion date
2030-12-31
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

COPD, Digital health intervention, Feasibility, Self-management, Mobile Application

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)

Interventions

DEVICEDigital health intervention by using a mobile application

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

OTHERFeasibilty 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.

Sponsors

Helse Forde
CollaboratorOTHER
Western Norway University of Applied Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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,

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rateFrom enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-upRecruitment rate (n, %)
Intervention adherenceFrom enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-upIntervention adherence (n, %)
Adverse eventsFrom enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-upAdverse events (n, %)
Dropout rateFrom enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-upDropout (n, %)
Health related outcomesFrom enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up\- Dyspnea-12 (D-12) scale score (score 0-36) - low score indicates better outcome
Health related outcomeFrom enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-upGeneralized Anxiety Disorder Assessment (GAD-7) (score 0-21) - low score indicates better outcome
Physical functioningFrom enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up60 seconds Sit-To-Stand (60sSTS) (number of repetitions) - Higher number of repetitions indicates better outcome
Exacerbations, hospital admissions and use of healthcare servicesFrom enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-upThe number of exacerbations, hospital admissions and use of healthcare services (n)
Health literacyFrom enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-upHealth Literacy Questionnaire (HLQ) (44 items, 9 domains) - Health literacy was measured using three domains of the HLQ; 3) Actively managing my health, 6) Ability to engage actively with health-care providers and 9) Understand health information well enough to know what to do. Domains 1-5 are scored 1-4, and domains 6-9 are scored 1-5. Lower score indicates lower levels of health literacy.
Health education and self-managementFrom enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-upHealth Education Impact Questionnaire (heiQ) (48 items, 8 domains) - is used to measure helath edcuation and self-management. We are using three domains of the heiQ; 2) Health related behaviour, 3) Skill and technique acquisition and 5) Self-monitoring and insight. Scores ranges from 1-4. Lower score indicates lower levels of health education impact and self-management.
Satisfaction with treatmentEnd of treatment at 8 weeks and the end of treatment at 6-month follow-upPatients Global Impression of Change (PGIC) (score 0-7) - low score indicates better outcome

Countries

Norway

Contacts

Primary ContactBente Frisk, PHD
bente.frisk@hvl.no0047- 55587143
Backup ContactSiri Dahl Aune, MSc
siri.dahl.aune@hvl.no0047-46417431

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026