CARNA - Evaluation study to assess medical benefits and positive care effects of app-based, guideline-compliant patient support in heart failure

Not Applicable

Recruiting

• Conditions: I50; Heart failure

• Registration Number: DRKS00027949
• Lead Sponsor: ProCarement GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

? Diagnosed heart failure (ICD code I50.-)
? NYHA- Stadium I, NYHA- Stadium II, NYHA-Stadium III
? EF < 40% or NT-proBNP > 500
? 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

? Not owning a smartphone or mobile device with internet access.
? Cognitive impairment with the inability to give consent to the protocol.
? Inability or unwillingness to complete app use (e.g. blindness, inadequate German language skills, limited informal self-determination)
? NYHA IV stage (I50.05 Right heart failure with symptoms at rest NYHA stage IV; I50.14 With symptoms at rest NYHA stage IV)
? Hospitalisation within the last 8 weeks before inclusion
? Condition after implantation of a mechanical cardiac assist system
? Acute coronary syndrome (troponin = 5 x ULN (Upper Limit of Normal)) within the last 8 weeks before inclusion
? High urgent HTX listing
? Planned revascularisation, TAVI, mitral clip, etc.
? Revascularisation and/or CRT implantation within the last 3 months
? Chronic drug or alcohol abuse as assessed by the physician.
? Terminal renal failure with haemodialysis treatment (ICD code N18.5)
? Diseases with a life expectancy of < 12 months
? Pregnancy
? Wheelchair use
? Participation in other intervention studies or other telemedicine programmes
? Participation in the CARNA pretest study.
? No valid Corona proof (depending on the regulations of the study centre) at the inclusion examination

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-5L Index <br>? Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Index <br>? Change in the 9-item European Heart Failure Self-care Behaviour Scale (G9-EHFScBS) <br>? Change in NYHA classification

Secondary Outcome Measures

Name	Time	Method
? Difference in 9-item Shared Decision-Making Questionnaire (SDM-Q-9) score.<br>? Difference in the Atlanta Heart Failure Knowledge Test (AHFKT). <br>? Difference in self-reported use of outpatient and inpatient health care.