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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024798

Enrollment

100

Registered

2021-04-30

Start date

2021-04-30

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50

Interventions

Group 1: Access to the ProHerz App, for 3 months

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
? 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.	—

Measure

Time frame

? 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.

—

Countries

Germany

Contacts

Public ContactSebastian Eckl

ProCarement GmbH

studie@procarement.com09191/9504312

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026