Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGerman Heart Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MobiDig
Other interventionThe application will contain the following modules: 1. information and knowledge about heart failure; 2. vital sign diary, which can be sent to the certified HFU 3. pedometer (individualized step-goal), cardiac home training videos 4. "frequently asked questions" and connection to a certified HFU provider by a heart failure hotline
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: MobiDigOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months2
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.
Time frame
Baseline and 3 months3
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.
Time frame
Baseline and 3 months4
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.
Time frame
Baseline and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
German Heart Institute
Lead sponsor
Federal Ministry of Health, Germany
Collaborator
Source ClinicalTrials.gov