Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg

NCT ID: NCT05422859

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MobiDig

50 patients will have access to a mobile phone application for 3 months.

Group Type OTHER

MobiDig

Intervention Type OTHER

The application will contain the following modules:

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

Interventions

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MobiDig

The application will contain the following modules:

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal Ministry of Health, Germany

OTHER_GOV

Sponsor Role collaborator

German Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Sabine Huebler

Head of Studienzentrale

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Deutsches Herzzentrum der Charité - Universitätsmedizin Berlin

Berlin, Deutschland, Germany

Site Status RECRUITING

Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum

Berlin, , Germany

Site Status RECRUITING

Herzzentrum Berlin

Bernau, , Germany

Site Status ACTIVE_NOT_RECRUITING

Countries

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Germany

Central Contacts

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Isabell A Just, Dr.

Role: CONTACT

00493045932025

Felix Schoenrath, Prof. Dr.

Role: CONTACT

00493045932085

Facility Contacts

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Isabell A Just, Dr.

Role: primary

+493045932025

Felix Schoenrath, Prof. Dr.

Role: backup

+493045932085

Frank Edelmann, Prof. Dr.

Role: primary

Other Identifiers

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MobiDig

Identifier Type: -

Identifier Source: org_study_id

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