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

NCT06850961 | Recruiting

• 1 other identifier: REK2024/733856
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (19)

• Recruitment rate

  Recruitment rate (n, %)

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Intervention adherence

  Intervention adherence (n, %)

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Adverse events

  Adverse events (n, %)

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Dropout rate

  Dropout (n, %)

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health related outcomes

  \- Dyspnea-12 (D-12) scale score (score 0-36) - low score indicates better outcome

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health related outcomes

  Modified Medical Research Council dyspnea scale (mMRC) (score 0-4) - low score indicates better outcome

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health related outcomes

  Chalder Fatigue Scale (CFQ-11) (score 0-33) - low score indicates better outcome

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health related outcomes

  COPD Assessment Test (CAT) (score 0-40) - low score indicates better outcome

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health related outcome

  Generalized Anxiety Disorder Assessment (GAD-7) (score 0-21) - low score indicates better outcome

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health related outcome

  Patient Health Questionnaire-9 (PHQ-9) (score 0-27) - low score indicates better outcome

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health related outcomes

  Patient Health Questionnaire-9 (PHQ-9) (score 0-27) - low score indicates better outcome

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health related outcomes

  EuroQol Questionnaire (EQ-5D) (index and VAS score 0-100) Index: An overall score is generated, ranging from \<0 to 1. Low score indicates worse outcome VAS score: low score indicates worse outcome

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Physical functioning

  60 seconds Sit-To-Stand (60sSTS) (number of repetitions) - Higher number of repetitions indicates better outcome

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Exacerbations, hospital admissions and use of healthcare services

  The number of exacerbations, hospital admissions and use of healthcare services (n)

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health literacy

  Health 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.

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health literacy

  E-Health Literacy Questionnaire (e-HLQ) (35 items, 7 domains) - E-Health literachy was measured using two domains of the e-HLQ; 3) Ability to actively engage with digital services and 5) Motivated to engage with digital services. Scores range from 1-4. Lower score indicates lower levels of e-Health literacy.

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Health education and self-management

  Health 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.

  From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up

• Satisfaction with treatment

  Patients Global Impression of Change (PGIC) (score 0-7) - low score indicates better outcome

  End of treatment at 8 weeks and the end of treatment at 6-month follow-up

• Satisfaction with treatment

  Client Satisfaction Questionnaire (CSQ-8) (score 8-32) - low score indicates worse outcome

  End of treatment at 8 weeks and the end of treatment at 6-month follow-up

Study Arms (1)

Digital health intervention group

EXPERIMENTAL

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

Device: Digital health intervention by using a mobile application; Other: Feasibilty study and qualitative interview studies

Interventions

Digital health intervention by using a mobile application DEVICE

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

Digital health intervention group

Feasibilty study and qualitative interview studies 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.

Digital health intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Western Norway University of Applied Sciences: lead
• Helse Forde: collaborator

Study Sites (1)

Western Norway University of Applied Sciences

Bergen, Norway, 5063, Norway

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bente Frisk, PHD

  Western Norway University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bente Frisk, PHD

CONTACT

0047- 55587143; bente.frisk@hvl.no

Siri Dahl Aune, MSc

CONTACT

0047-46417431; siri.dahl.aune@hvl.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The investigators will use the mobile app "Pust Deg Bedre" to explore the feasibility and experiences of providing PDB for patients with COPD,

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: February 28, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Will be available after data completion of the study: 31.12.30
• 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 Bente Frisk: bente.frisk@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.

Locations

NO (1)