Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg

Heart Failure Clinical Trial

— MobiDig  

Official title:

Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05422859
• Other study ID #: MobiDig
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: German Heart Institute
• Contact: Isabell A Just, Dr.
• Phone: 00493045932025
• Email: ijust[@]dhzb.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• MobiDig
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

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum	Berlin
Germany	Isabell A Just	Berlin	Deutschland
Germany	Herzzentrum Berlin	Bernau

Sponsors (2)

Lead Sponsor	Collaborator
German Heart Institute	Federal Ministry of Health, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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