Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Other: MobiDig

• Registration Number: NCT05422859
• Lead Sponsor: German Heart Institute

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-21
• Study Start: 2022-07-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MobiDig	MobiDig	50 patients will have access to a mobile phone application for 3 months.

Primary Outcome Measures

Name	Time	Method
Acceptance of the application	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.
Change in symptoms of heart failure	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.
Change in six-minute walk distance	Baseline and 3 months	Functional capacity will be assessed by the 6-minute walk test
Length of hospitalizations	3 months	Length of in-hospital stay of hospitalizations for heart failure will be assessed.
Patient reported outcomes	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.
Change in daily walking distances	Baseline and 3 months	Functional capacity will be assessed by the steps taken within 24 hours (pedometry).
Change in quality of life	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.
Change in heart failure biomarker	Baseline and 3 months	Heart failure severity will be assessed by the biomarker NT-proBNP.
Number of hospitalizations	3 months	Number of hospitalizations for heart failure will be assessed.

Trial Locations

Locations (3)

Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany

Herzzentrum Berlin; 🇩🇪 Bernau, Germany

Deutsches Herzzentrum der Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Deutschland, Germany