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

Study Overview
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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).

Official Title
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Evaluating the Feasibility of a Mobile Self-management Application for Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: COPD app


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-management - change over time | Self-management using Partner in Health Scale. The items are rated on a 9-point Likert scale varying from 0 (low self-management) to 8 (high self-management). | Baseline, week 8 and week 20 | 
| Expectations | Expectations with technology: using questions covering constructs of Unified Theory of Acceptance and Use of Technology. The items were rated on a 7 point scale varying from 1 (totally disagree) to 7 (totally agree). | Baseline | 
| Experiences with technology | Experiences with technology: using questions covering constructs of Unified Theory of Acceptance and Use of Technology. The items were rated on a 7 point scale varying from 1 (totally disagree) to 7 (totally agree). | Week 8 | 
| Experiences with technology | Experiences with technology: using questions covering constructs of Unified Theory of Acceptance and Use of Technology. The items were rated on a 7 point scale varying from 1 (totally disagree) to 7 (totally agree). | Week 20 | 
| Anxiety - change over time | Hospital Anxiety and Depression Scale. Seven items were rated on a 4 points Likert scale, varying from 0 (lowest anxiety level) to 3 (highest anxiety level). | Week 1 until week 8 | 
| Depression - change over time | Hospital Anxiety and Depression Scale. Seven items were rated on a 4 points Likert scale, varying from 0 (lowest depression level) to 3 (highest depression level). | Week 1 and Week 8 | 
| Satisfaction nurses | Questions to assess nurses' experiences with the application, satisfaction, time investment and integration in their work process. The items were rated on a 5 point scale, varying from 1 (totally disagree) to 5 (totally agree). Overall satisfaction was rated on a scale from 1 (not satisfied) to 10 (very satisfied). | After intervention completion, up to 15 months. | 
| Hospital readmissions | Hospital admissions for at least 24 hours. The number of hospital admissions was obtained from the Electronic Medical Record. This was compared with the readmission rate from the previous year, November 2017 until November 2018. | 30 days | 
| Hospital readmissions | Hospital admissions for at least 24 hours. The number of hospital admissions was obtained from the Electronic Medical Record. This was compared with the readmission rate from the previous year, November 2017 until November 2018. | 8 weeks | 
| Hospital readmissions | Hospital admissions for at least 24 hours. The number of hospital admissions was obtained from the Electronic Medical Record. This was compared with the readmission rate from the previous year, November 2017 until November 2018. | 20 weeks | 
| Use | Questions about use of the application: number of times and time in minutes (multiple choice question), use of the different functionalities and which functionality is most important (multiple response question), if patients experienced problems (yes/no), received help using the application (yes/no) and if people in their environment helped them using the app (yes/no). | Week 8 | 
| Use | Questions about use of the application: number of times and time in minutes (multiple choice question), use of the different information items and which item is most important (multiple response question), if patients experienced problems (yes/no), received help using the application (yes/no) and if people in their environment helped them using the app (yes/no). | Week 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Self-management, Blended care