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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
COPD app
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring mHealth, Self-management, Blended care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rijnstate

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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).
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).

Full Information

First Posted
August 25, 2020
Last Updated
August 31, 2020
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04540562
Brief Title
Evaluating a Mobile Self-management Application for Patients With COPD Chronic Obstructive Pulmonary Disease
Official Title
Evaluating the Feasibility of a Mobile Self-management Application for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 22, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
mHealth, Self-management, Blended care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
COPD app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Use (feasibility)
Description
Use based on log data: number of times the app was used per week.
Time Frame
Week 1 through week 20
Title
Satisfaction (feasibility)
Description
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).
Time Frame
Week 8
Title
Overall satisfaction (feasibility)
Description
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.
Time Frame
Week 20
Secondary Outcome Measure Information:
Title
Self-management - change over time
Description
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).
Time Frame
Baseline, week 8 and week 20
Title
Expectations
Description
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).
Time Frame
Baseline
Title
Experiences with technology
Description
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).
Time Frame
Week 8
Title
Experiences with technology
Description
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).
Time Frame
Week 20
Title
Anxiety - change over time
Description
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).
Time Frame
Week 1 until week 8
Title
Depression - change over time
Description
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).
Time Frame
Week 1 and Week 8
Title
Satisfaction nurses
Description
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).
Time Frame
After intervention completion, up to 15 months.
Title
Hospital readmissions
Description
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.
Time Frame
30 days
Title
Hospital readmissions
Description
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.
Time Frame
8 weeks
Title
Hospital readmissions
Description
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.
Time Frame
20 weeks
Title
Use
Description
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).
Time Frame
Week 8
Title
Use
Description
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).
Time Frame
Week 20
Other Pre-specified Outcome Measures:
Title
Age
Description
Age extracted from Electronic Medical Record.
Time Frame
Baseline
Title
Education
Description
Multiple choice question.
Time Frame
Baseline
Title
Partner
Description
Living together with a partner (yes/no question).
Time Frame
Baseline
Title
Children
Description
Having children (yes/no question).
Time Frame
Baseline
Title
Internet use (duration)
Description
Multiple choice question, varying from less than six months to more than 3 years
Time Frame
Baseline
Title
Frequency internet use
Description
Multiple choice question, varying from every day to never.
Time Frame
Baseline
Title
Tablet/smartphone skills
Description
Question with 5 point scale varying from 1 (very bad) to 5 (very good).
Time Frame
Baseline
Title
Help needed to use app on smartphone/tablet
Description
Yes/no question. If yes: open question to answer who was asked for help.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim van Harten, MD, PhD
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate
City
Arnhem
ZIP/Postal Code
6815AD
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33538699
Citation
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.
Results Reference
derived

Learn more about this trial

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

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