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

Not Applicable

• Conditions: I50; Heart failure

• Registration Number: DRKS00024798
• Lead Sponsor: ProCarement GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Study Completion: 2021-08-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 71

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

? 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
? Change in the 6-minute walk test<br>? Change in EQ-5D-L Index<br>? Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Index<br>? Change in the 9-item European Heart Failure Self-care Behaviour Scale (G9-EHFScBS)<br>? Change in 9-item Shared Decision Making Questionnaire (SDM-Q-9) score.<br>? Change in Atlanta Heart Failure Knowledge Test (AHFKT) score.<br>? Change in the NYHA classification<br>? Self-reported utalisation of outpatient and inpatient health care services<br>? Intensity of the use of the ProHerz app over the observation period<br>?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.