Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- German Heart Institute
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Acceptance of the application
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Sabine Huebler
Head of Studienzentrale
German Heart Institute
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
Outcomes
Primary Outcomes
Acceptance of the application
Time Frame: 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
Time Frame: 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
Time Frame: Baseline and 3 months
Functional capacity will be assessed by the 6-minute walk test
Length of hospitalizations
Time Frame: 3 months
Length of in-hospital stay of hospitalizations for heart failure will be assessed.
Patient reported outcomes
Time Frame: 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
Time Frame: Baseline and 3 months
Functional capacity will be assessed by the steps taken within 24 hours (pedometry).
Change in quality of life
Time Frame: 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
Time Frame: Baseline and 3 months
Heart failure severity will be assessed by the biomarker NT-proBNP.
Number of hospitalizations
Time Frame: 3 months
Number of hospitalizations for heart failure will be assessed.