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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04540562
• Other study ID #: 2018-1257
• Status: Completed
• Phase: N/A
• Start date: November 22, 2018
• Est. completion date: April 25, 2020

Study information

• Verified date: August 2020
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 25, 2020
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	Rijnstate	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Age extracted from Electronic Medical Record.	Baseline
Other	Education	Multiple choice question.	Baseline
Other	Partner	Living together with a partner (yes/no question).	Baseline
Other	Children	Having children (yes/no question).	Baseline
Other	Internet use (duration)	Multiple choice question, varying from less than six months to more than 3 years	Baseline
Other	Frequency internet use	Multiple choice question, varying from every day to never.	Baseline
Other	Tablet/smartphone skills	Question with 5 point scale varying from 1 (very bad) to 5 (very good).	Baseline
Other	Help needed to use app on smartphone/tablet	Yes/no question. If yes: open question to answer who was asked for help.	Baseline
Primary	Use (feasibility)	Use based on log data: number of times the app was used per week.	Week 1 through week 20
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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