NCT05422859

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

2.5 years

First QC Date

June 8, 2022

Last Update Submit

July 3, 2024

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (1)

MobiDig

OTHER

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

Other: MobiDig

Interventions

MobiDigOTHER

The 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

MobiDig

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Deutsches Herzzentrum der Charité - Universitätsmedizin Berlin

Berlin, Deutschland, 13353, Germany

RECRUITING

Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum

Berlin, 13353, Germany

RECRUITING

Herzzentrum Berlin

Bernau, Germany

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Isabell A Just, Dr.

CONTACT

00493045932025ijust@dhzb.de

Felix Schoenrath, Prof. Dr.

CONTACT

00493045932085schoenrath@dhzb.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Studienzentrale

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 21, 2022

Study Start

July 1, 2022

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)