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Completed

NCT Number: NCT04540562

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate

Arnhem, 6815AD, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Use (feasibility)

    Time frame: Week 1 through week 20

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

  2. Satisfaction (feasibility)

    Time frame: Week 8

    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).

  3. Overall satisfaction (feasibility)

    Time frame: Week 20

    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 outcomes

  1. Self-management - change over time

    Time frame: Baseline, week 8 and week 20

    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).

  2. Expectations

    Time frame: Baseline

    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).

  3. Experiences with technology

    Time frame: Week 8

    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).

  4. Experiences with technology

    Time frame: Week 20

    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).

  5. Anxiety - change over time

    Time frame: Week 1 until week 8

    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).

  6. Depression - change over time

    Time frame: Week 1 and Week 8

    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).

  7. Satisfaction nurses

    Time frame: After intervention completion, up to 15 months.

    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).

  8. Hospital readmissions

    Time frame: 30 days

    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.

  9. Hospital readmissions

    Time frame: 8 weeks

    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.

  10. Hospital readmissions

    Time frame: 20 weeks

    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.

  11. Use

    Time frame: Week 8

    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).

  12. Use

    Time frame: Week 20

    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).

Other outcomes

  1. Age

    Time frame: Baseline

    Age extracted from Electronic Medical Record.

  2. Education

    Time frame: Baseline

    Multiple choice question.

  3. Partner

    Time frame: Baseline

    Living together with a partner (yes/no question).

  4. Children

    Time frame: Baseline

    Having children (yes/no question).

  5. Internet use (duration)

    Time frame: Baseline

    Multiple choice question, varying from less than six months to more than 3 years

  6. Frequency internet use

    Time frame: Baseline

    Multiple choice question, varying from every day to never.

  7. Tablet/smartphone skills

    Time frame: Baseline

    Question with 5 point scale varying from 1 (very bad) to 5 (very good).

  8. Help needed to use app on smartphone/tablet

    Time frame: Baseline

    Yes/no question. If yes: open question to answer who was asked for help.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 7, 2020
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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