Heart FailureMobiDigNCT05422859
Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg
A study testing MobiDig in people with Heart Failure, run by German Heart Institute at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- MobiDig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Jul 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Germany3 sites, 2 recruiting
- Recruiting
Deutsches Herzzentrum der Charité - Universitätsmedizin Berlin
Berlin, Deutschland, 13353
Isabell A Just, Dr., +493045932025, ijust@dhzb.de
Felix Schoenrath, Prof. Dr., +493045932085, schoenrath@dhzb.de
- Recruiting
Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum
Berlin, 13353
Frank Edelmann, Prof. Dr.
- Active, not recruiting
Herzzentrum Berlin
Bernau
About this study
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.
- Conditions
- Heart Failure
- Being tested
- MobiDig
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobiDigOther
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
| Study group | Role | What they receive |
|---|---|---|
| MobiDig | Other | 50 patients will have access to a mobile phone application for 3 months. Receives: Other: MobiDig |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months
Change in six-minute walk distance
Functional capacity will be assessed by the 6-minute walk test
Measured: Baseline and 3 months
Change in daily walking distances
Functional capacity will be assessed by the steps taken within 24 hours (pedometry).
Measured: Baseline and 3 months
Change in heart failure biomarker
Heart failure severity will be assessed by the biomarker NT-proBNP.
Measured: Baseline and 3 months
Number of hospitalizations
Number of hospitalizations for heart failure will be assessed.
Measured: 3 months
Length of hospitalizations
Length of in-hospital stay of hospitalizations for heart failure will be assessed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jul 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Health, Germany
- Responsible party
- Principal investigator, Sabine Huebler, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422859
- Sponsor's protocol ID
- MobiDig
- Acronym
- MobiDig
- Status last verified
- Jul 2024
- First submitted
- 8 Jun 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg
- ClinicalTrials.gov ID
- NCT05422859
- Acronym / sponsor ID
- MobiDig / MobiDig
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Federal Ministry of Health, Germany
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MobiDig | Other | Other: MobiDig50 patients will have access to a mobile phone application for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MobiDigThe 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 | Other | MobiDig |
Primary outcome
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 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.
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 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
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 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.
Length of hospitalizations
Time frame: 3 months
Length of in-hospital stay of hospitalizations for heart failure will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MobiDig in people with Heart Failure, run by German Heart Institute at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabell A Just, Dr. (00493045932025, ijust@dhzb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of the application (time frame: 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.