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

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MobiDig
Sponsored by
German Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Isabell A Just
  • Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum
  • Herzzentrum Berlin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MobiDig

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 8, 2022
Last Updated
June 16, 2022
Sponsor
German Heart Institute
Collaborators
Federal Ministry of Health, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05422859
Brief Title
Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg
Acronym
MobiDig
Official Title
Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Heart Institute
Collaborators
Federal Ministry of Health, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MobiDig
Arm Type
Other
Arm Description
50 patients will have access to a mobile phone application for 3 months.
Intervention Type
Other
Intervention Name(s)
MobiDig
Intervention Description
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 Outcome Measure Information:
Title
Acceptance of the application
Description
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.
Time Frame
3 months
Title
Change in quality of life
Description
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.
Time Frame
Baseline and 3 months
Title
Patient reported outcomes
Description
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.
Time Frame
Baseline and 3 months
Title
Change in symptoms of heart failure
Description
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.
Time Frame
Baseline and 3 months
Title
Change in six-minute walk distance
Description
Functional capacity will be assessed by the 6-minute walk test
Time Frame
Baseline and 3 months
Title
Change in daily walking distances
Description
Functional capacity will be assessed by the steps taken within 24 hours (pedometry).
Time Frame
Baseline and 3 months
Title
Change in heart failure biomarker
Description
Heart failure severity will be assessed by the biomarker NT-proBNP.
Time Frame
Baseline and 3 months
Title
Number of hospitalizations
Description
Number of hospitalizations for heart failure will be assessed.
Time Frame
3 months
Title
Length of hospitalizations
Description
Length of in-hospital stay of hospitalizations for heart failure will be assessed.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabell A Just, Dr.
Phone
00493045932025
Email
ijust@dhzb.de
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Schoenrath, Prof. Dr.
Phone
00493045932085
Email
schoenrath@dhzb.de
Facility Information:
Facility Name
Isabell A Just
City
Berlin
State/Province
Deutschland
ZIP/Postal Code
13353
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Herzzentrum Berlin
City
Bernau
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg

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