Evaluating a Mobile Self-management Application for Patients With COPD Chronic Obstructive Pulmonary Disease

NCT ID: NCT04540562

Last Updated: 2020-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-22

Study Completion Date

2020-04-25

Brief Summary

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The objective of the study is to evaluate the effects of a mobile self-management app in clinical practice for recently discharged COPD patients on application use, self-management, anxiety and depression, expectations and experiences, patients' and health care professionals' satisfaction and hospital readmissions.

Detailed Description

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Usability testing techniques were used to receive feedback on a prototype of the app, before starting the feasibility study. Patients were recruited from a large teaching hospital. The COPD app provided patients with an 8 week self-management program. The application had three views: timeline, information page, and contact page. The start date was each patients' date of discharge. The timeline was classified in 8 weeks, and each week included the lung exacerbation plan, daily and extra medication, information and education and questionnaires. The first week also included a video of a pulmonologist explaining the purpose of the app and additional information about the functionalities of the COPD app. The timeline consisted of the lung exacerbation action plan, medication overview, weekly questionnaires and monitoring, and consultations (video consultation after 4 weeks and face-to-face consultation after 8 weeks).

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

The COPD app consisted of an 8 week self-management program. The app had three views: timeline, information page, and contact page. The timeline was classified in 8 weeks, and each week included the lung exacerbation plan, daily and extra medication, information and education and questionnaires. The first week also included a video of a pulmonologist explaining the purpose of the app and additional information about the functionalities of the COPD app. A video consultation was planned after after 4 weeks and a face-to-face consultation after 8 weeks.

Group Type EXPERIMENTAL

COPD app

Intervention Type OTHER

The COPD app consisted of an 8 week self-management program. The app had three views: timeline, information page, and contact page. The timeline was classified in 8 weeks, and each week included the lung exacerbation plan, daily and extra medication, information and education and questionnaires. The first week also included a video of a pulmonologist explaining the purpose of the app and additional information about the functionalities of the COPD app. A video consultation was planned after after 4 weeks and a face-to-face consultation after 8 weeks.

Interventions

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COPD app

The COPD app consisted of an 8 week self-management program. The app had three views: timeline, information page, and contact page. The timeline was classified in 8 weeks, and each week included the lung exacerbation plan, daily and extra medication, information and education and questionnaires. The first week also included a video of a pulmonologist explaining the purpose of the app and additional information about the functionalities of the COPD app. A video consultation was planned after after 4 weeks and a face-to-face consultation after 8 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 Years
* Diagnosed with COPD
* Admissions to the hospital for exacerbation
* Having (access to) a tablet or smartphone
* Working internet connection
* Proficiency in using a tablet or smartphone
* Ability to read and understand the Dutch language
* Signed informed consent
* At least one hospitalization for COPD exacerbation in the year preceding the study (outcome was...)

Exclusion Criteria

* No exacerbation of COPD
* Comorbidities: cancer, severe cognitive or psychiatric comorbidities
* No access to a tablet or smartpone
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wim van Harten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

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Rijnstate

Arnhem, , Netherlands

Site Status

Countries

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Netherlands

References

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Kooij L, Vos PJE, Dijkstra A, van Harten WH. Effectiveness of a Mobile Health and Self-Management App for High-Risk Patients With Chronic Obstructive Pulmonary Disease in Daily Clinical Practice: Mixed Methods Evaluation Study. JMIR Mhealth Uhealth. 2021 Feb 4;9(2):e21977. doi: 10.2196/21977.

Reference Type DERIVED
PMID: 33538699 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018-1257

Identifier Type: -

Identifier Source: org_study_id

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