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

Summary

The number of patients with end-stage heart disease requiring the implantation of ventricular assist devices (VAD) is steadily increasing. Living with a VAD exposes the patients to multiple challenges and the need to learn complex self-management skills. Inadequate self-management can lead to serious complications (e.g. bleeding or wound infections) and impair the psychosocial outcome. This study aims to provide multi-centered actual analysis of self-management capabilities as well as analyzing moderating predictors in VAD patients through standardized prevalence assessment. Using a cross-sectional design, this prevalence study will be conducted at four established German heartcenters (Freiburg, Berlin, Bad Oeynhausen, Leipzig). VAD-patients are questioned about their self-management skills using standardized Patient-reported outcome (PRO) measures. Secondary PRO measures include health-related quality of life, symptoms of anxiety and depression, post-traumatic stress symptoms, social support, and changed body-image. Relevant complications (bleeding, wound infections, thromboembolic neurological events) are taken from the patient records. Based on a conservative sample size estimation inclusion of 450 patients is envisioned. The expected results may contribute to an improved assessment of the current situation in terms of self-management skills and needs for curricular training concepts and psychosocial concomitant therapy. Long-term, the study results contribute to improve the health care for long-term VAD patients.

Conditions

• Ventricular Assist Device
• Self-management
• Psychological Factors

Interventions

OTHER

Prevalence Survey

Questionnaire survey on self-management

Sponsors & Collaborators

• University Heart Center Freiburg - Bad Krozingen

  collaborator OTHER

• Heart and Diabetes Center North-Rhine Westfalia

  collaborator OTHER

• German Heart Center

  collaborator OTHER

• Heart Center Leipzig - University Hospital

  collaborator OTHER

• University of Freiburg

  lead OTHER

Principal Investigators

• Christiane Kugler, Prof. Dr. · University of Freiburg

• Christiane Kugler, Prof. Dr. · University of Freiburg

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2020-08-31

Completion

2020-09-30

Countries

• Germany

Study Locations