Clinical trial NCT04540562: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: mHealth
Self-management
Blended care
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Use (feasibility)
timeFrame: Week 1 through week 20
measure: Satisfaction (feasibility)
timeFrame: Week 8
measure: Overall satisfaction (feasibility)
timeFrame: Week 20
Secondary outcomes:
measure: Self-management - change over time
timeFrame: Baseline, week 8 and week 20
measure: Expectations
timeFrame: Baseline
measure: Experiences with technology
timeFrame: Week 8
measure: Experiences with technology
timeFrame: Week 20
measure: Anxiety - change over time
timeFrame: Week 1 until week 8
measure: Depression - change over time
timeFrame: Week 1 and Week 8
measure: Satisfaction nurses
timeFrame: After intervention completion, up to 15 months.
measure: Hospital readmissions
timeFrame: 30 days
measure: Hospital readmissions
timeFrame: 8 weeks
measure: Hospital readmissions
timeFrame: 20 weeks
measure: Use
timeFrame: Week 8
measure: Use
timeFrame: Week 20
Other outcomes:
measure: Age
timeFrame: Baseline
measure: Education
timeFrame: Baseline
measure: Partner
timeFrame: Baseline
measure: Children
timeFrame: Baseline
measure: Internet use (duration)
timeFrame: Baseline
measure: Frequency internet use
timeFrame: Baseline
measure: Tablet/smartphone skills
timeFrame: Baseline
measure: Help needed to use app on smartphone/tablet
timeFrame: Baseline
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate
Study officials:
affiliation: Rijnstate Hospital
name: Wim van Harten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.