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

NCT04540562 | Completed

• 1 other identifier: 2018-1257
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

mHealth; Self-management; Blended care

Outcome Measures

Primary Outcomes (3)

• Use (feasibility)

  Use based on log data: number of times the app was used per week.

  Week 1 through week 20

• Satisfaction (feasibility)

  Questionnaires were used to assess satisfaction, information and user-friendliness of the app. The items were rated on a 7 point scale, varying from 1 (totally disagree) to 7 (totally agree). Overall satisfaction was rated on a scale from 1 (very unsatisfied) to 10 (very satisfied). Multiple response questions were used to assess if patients missed information in the app. Suggestions for improvement were asked using an open question. Yes/no questions were used to assess satisfaction with video consultation(s) (additional requested video consultations, problems and time saving).

  Week 8

• Overall satisfaction (feasibility)

  Overall satisfaction was rated on a scale varying from 1 (not satisfied) to 10 (very satisfied). Suggestion for improvement were assessed with an open question.

  Week 20

Secondary Outcomes (12)

• Self-management - change over time

  Baseline, week 8 and week 20

• Expectations

  Baseline

• Experiences with technology

  Week 8

• Experiences with technology

  Week 20

• Anxiety - change over time

  Week 1 until week 8

Other Outcomes (8)

• Age

  Baseline

• Education

  Baseline

• Partner

  Baseline

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Other: COPD app

Interventions

COPD app 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.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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...)

You may not qualify if:

• No exacerbation of COPD
• Comorbidities: cancer, severe cognitive or psychiatric comorbidities
• No access to a tablet or smartpone

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate

Arnhem, 6815AD, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33538699 DERIVED

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

• Wim van Harten, MD, PhD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 7, 2020
• Study Start: November 22, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 25, 2020
• Last Updated: September 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)