Trial document



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  DRKS00024798

Trial Description

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Title

CARNA Pretest - Pre-study to assess a medical benefit and positive care effects of an app-based, guideline-compliant patient support in heart failure.

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Trial Acronym

CARNA Pretest

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URL of the Trial

https://procarement.com/studie/

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Brief Summary in Lay Language

For patients with heart failure, regular monitoring of health status to adjust treatment and avoid complications is a critical component of care. Telemedicine interventions that facilitate such monitoring have already led to positive care effects in other trials. The ProHerz app is a software application that supports guideline-based care. In combination with wearables, vital parameters are collected and evaluated, and the user is given information about his or her health status to enable better management. In order to make this care approach the norm, the app is to be listed as a digital health application (DiGA). By means of a clinical trial, positive health care effects are to be proven in accordance with the Digital Health Care Act (DVG). To test the feasibility, this preliminary study precedes the clinical evaluation trial in cooperation with the Nuremberg Hospital.

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Brief Summary in Scientific Language

The aim of the single-center, national, exploratory trial is to investigate how an evaluation trail on the use of the ProHeart App can be conducted for a positive care effect according to the Digital Care Act (DVG) for patients with heart failure. The ProHerz App is a software application that supports guideline-based care.
It will be examined whether the selected measurement instruments of the study (such as standardised gait tests, patient questionnaires) provide indications of the care effects. In addition, it will be examined whether the study design can be implemented for an evaluation trial with regard to recruitment, data collection, drop-out rate and sample size. In addition, the usability of the ProHerz app will be evaluated.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00024798
  •   2021/04/30
  •   [---]*
  •   no
  •   Approved
  •   21022, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I50 -  Heart failure
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Interventions/Observational Groups

  •   Access to the ProHerz App, for 3 months
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

▪ Change in the 6-minute walk test
▪ Change in EQ-5D-L Index
▪ Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Index
▪ Change in the 9-item European Heart Failure Self-care Behaviour Scale (G9-EHFScBS)
▪ Change in 9-item Shared Decision Making Questionnaire (SDM-Q-9) score.
▪ Change in Atlanta Heart Failure Knowledge Test (AHFKT) score.
▪ Change in the NYHA classification
▪ Self-reported utalisation of outpatient and inpatient health care services
▪ Intensity of the use of the ProHerz app over the observation period
▪Survey of the usability of the ProHerz app with the System Usability Score (SUS), the manufacturer's own questions and an interview of max. 30 minutes.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2021/04/30
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

▪ Diagnosed heart failure (ICD code I 50 ff)
▪ Age > 18 years
▪ Ability to speak and read in German
▪ Ability to use an application running on a smartphone or other mobile device
▪ Informed consent of the study participant

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Exclusion Criteria

▪ No possession of a smartphone or mobile device with internet access.
▪ Cognitive impairment with the inability to give consent to the protocol.
▪ Inability or unwillingness to use an app (e.g. dementia, blindness, deafness, wheelchair use, insufficient German language skills, limited informal self-determination)
▪ Hospitalisation within the last 7 days
▪ Condition after implantation of a mechanical cardiac assist system
▪ Acute coronary syndrome within the last 7 days
▪ high urgent HTX listing
▪ Planned revascularisation, TAVI; mitral clip, etc.
▪ CRT implantation within the last 3 months
▪ Revascularisation and/or CRT implantation within the last 3 months
▪ Chronic drug or alcohol abuse according to the doctor's assessment
▪ Terminal renal failure with haemodialysis treatment (ICD code N18.5)
▪ Diseases with a life expectancy < 12 months
▪ Pregnancy
▪ Participation in other therapy studies or other telemedicine programmes
▪ Indication of corona disease

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Addresses

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    • ProCarement GmbH
    • Ms.  Patricia  Trißler 
    • Äußere Nürnberger Str. 62
    • 91301  Forchheim
    • Germany
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    • ZEW-Leibniz-Zentrum für Europäische Wirtschaftsforschung GmbH
    • Mr.  Dr.  Simon  Reif 
    • L 7,1
    • 68161  Mannheim
    • Germany
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    • dmac- Medical Valley Digital Health Application Center GmbH
    • Ms.  Sophie  Terheyden 
    • Promenadestr. 6a
    • 96047  Bamberg
    • Germany
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    • ProCarement GmbH
    • Mr.  Dr. med.  Sebastian  Eckl 
    • Äußere Nürnberger Str. 62
    • 91301  Forchheim
    • Germany
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Sources of Monetary or Material Support

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    • ProCarement GmbH
    • Ms.  Patricia  Trißler 
    • Äußere Nürnberger Str. 62
    • 91301  Forchheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2021/08/28
  •   71
  •   71
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.