Improved Self-management for Patients on Ventricular Assist Device (VAD) Support - Phase 3

NACompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

September 7, 2020

Primary Completion Date

January 15, 2023

Study Completion Date

January 15, 2023

Conditions
Ventricular Assist DevicePsychosocial FactorsSelf-management
Interventions
BEHAVIORAL

Self-management curriculum

The Intervention starts during inpatient phase after relocation of potential study participants from the intensive care unit to normal ward and after informed consent to participate. Those subjects assigned to the CGr by randomization code receive standard care at the respective center. Subjects assigned to the IGr received, in addition to standard care, a multi-modular self-management training carried out at the respective center. The content of the self-management training should be deepened and consolidated through a supplementary app. Training is performed during inpatient post-implant phase, as well as one refresher session about six weeks after discharge during regular outpatient follow-up. The intervention lasts 3 months, plus a 9-month follow-up per subject. The content of the self-management training is based on current evidence and was written in a curriculum to achieve the highest possible standardization, taking into account the center specifics.

Trial Locations (4)

13353

German Heart Center Berlin, Berlin

32545

Heart and Diabetes Center NRW, Bad Oeynhausen, Bad Oeynhausen

79110

University Heart Center Freiburg • Bad Krozingen, Freiburg im Breisgau

04289

Leipzig Heart Center, Leipzig

All Listed Sponsors
collaborator

University Heart Center Freiburg - Bad Krozingen

OTHER

collaborator

Heart and Diabetes Center North Rhine-Westphalia

OTHER

collaborator

German Heart Center

OTHER

collaborator

Heart Center Leipzig - University Hospital

OTHER

lead

University of Freiburg

OTHER

NCT04526964 - Improved Self-management for Patients on Ventricular Assist Device (VAD) Support - Phase 3 | Biotech Hunter | Biotech Hunter