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NCT Number: NCT05422859

Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg

The MobiDig trial is designed to evaluate an implementation of a mobile phone application with secondary preventive/rehabilitative modules for patients with heart failure in certified Heart Failure Unit centers in Berlin and Brandenburg.

The aim is to evaluate the effect on quality of life, symptoms and the course of the disease. In addition, the acceptance, adherence and user behavior as well as the implementation potential for a permanent introduction of the application in national heart failure networks will be analyzed.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches Herzzentrum der Charité - Universitätsmedizin Berlin, Berlin, Deutschland, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of heart failure
  • Treatment in a certified Heart Failure Unit center in Berlin or Brandenburg
  • Written informed consent of the participants
  • User of a mobile device with an iOS operating system

Exclusion criteria

  • Addiction or other illnesses that do not allow the participants to assess the nature and scope as well as possible consequences of participation or its scientific evaluation
  • insufficient knowledge of the German language, which is necessary to use the application

Treatment and study plan

MobiDig

Other

The application will contain the following modules:

  • information and knowledge about heart failure;
  • vital sign diary, which can be sent to the certified HFU
  • pedometer (individualized step-goal), cardiac home training videos
  • "frequently asked questions" and connection to a certified HFU provider by a heart failure hotline

Primary outcomes

  1. Acceptance of the application

    Time frame: 3 months

    The acceptence of the application will be measured by the User Experience Questionnaire. It consists of 9 items that can be rated on a 7-point Likert scale. -3 (fully agree with negative term) to +3 (fully agree with positive term). A higher total score means a better outcome.

  2. Change in quality of life

    Time frame: Baseline and 3 months

    Quality of life measured by Kansas City Cardiomyopathy Questionnaire using the validated 12-item version which has been described by Spertus et Jones (doi: 10.1161/CIRCOUTCOMES.115.001958.) A higher score means a better outcome.

  3. Patient reported outcomes

    Time frame: Baseline and 3 months

    Health-related quality of life will be measured by the "Patient Related Outcome and Measurement Information System" (PROMIS) test. Including 23 items that will be analyzed via Likert scale 1 (impossible/never) to 5 (no limitations/very good). A higher score means a better outcome.

  4. Change in symptoms of heart failure

    Time frame: Baseline and 3 months

    Symptoms of heart failure will be assessed by the New York Heart Association functional class. Consisting of four classes (I-IV), the higher, the worse the outcome.

  5. Change in six-minute walk distance

    Time frame: Baseline and 3 months

    Functional capacity will be assessed by the 6-minute walk test

  6. Change in daily walking distances

    Time frame: Baseline and 3 months

    Functional capacity will be assessed by the steps taken within 24 hours (pedometry).

  7. Change in heart failure biomarker

    Time frame: Baseline and 3 months

    Heart failure severity will be assessed by the biomarker NT-proBNP.

  8. Number of hospitalizations

    Time frame: 3 months

    Number of hospitalizations for heart failure will be assessed.

  9. Length of hospitalizations

    Time frame: 3 months

    Length of in-hospital stay of hospitalizations for heart failure will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Schoenrath, Prof. Dr.

CONTACT

[email protected]

00493045932085

Isabell A Just, Dr.

CONTACT

[email protected]

00493045932025

Sponsors and collaborators

Lead sponsor

German Heart Institute

Other

Collaborators

  • Federal Ministry of Health, Germany

Registry information

Acronym: MobiDig

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Jul 5, 2024

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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