Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg (MobiDig)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: MobiDig

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabell A Just, Dr.; Phone Number: 00493045932025; Email: ijust@dhzb.de
• Study Contact Backup: Name: Felix Schoenrath, Prof. Dr.; Phone Number: 00493045932085; Email: schoenrath@dhzb.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum
  • Bernau, Germany
    • Herzzentrum Berlin
  • Deutschland
    • Berlin, Deutschland, Germany, 13353
      • Isabell A Just

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MobiDig; 50 patients will have access to a mobile phone application for 3 months.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Change in six-minute walk distance	Functional capacity will be assessed by the 6-minute walk test	Baseline and 3 months
Change in daily walking distances	Functional capacity will be assessed by the steps taken within 24 hours (pedometry).	Baseline and 3 months
Change in heart failure biomarker	Heart failure severity will be assessed by the biomarker NT-proBNP.	Baseline and 3 months
Number of hospitalizations	Number of hospitalizations for heart failure will be assessed.	3 months
Length of hospitalizations	Length of in-hospital stay of hospitalizations for heart failure will be assessed.	3 months

Collaborators and Investigators

• Sponsor: German Heart Institute
• Collaborators: Federal Ministry of Health, Germany

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MobiDig

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No