Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04234230 |
| Other study ID # |
01VSF18012 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
September 30, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
University of Freiburg |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The number of patients with end-stage heart disease requiring the implantation of ventricular
assist devices (VAD) is steadily increasing. Due to advanced compensatory technological
developments, VAD support has been established as a recognized therapy concept for the
long-term care of those affected. Indications include a multi-year bridging therapy (up to 10
years) and increasingly a destination therapy. The Euromacs Register published the second
report in 2018 and reported 2,947 registered VAD implantations in 2016 (+257 percent).
Euromacs further points to a rising trend and demand for the use of VAD systems. In Germany,
an increase of VAD implantation by 36.6 percent has been reported since 2011. The position
paper of the German Society of Cardiology (2016) points to the fact that the range of
indications for VAD implantation for patients with chronic heart disease will continue to
change. The ISHLT Guideline (International Society for Heart and Lung Transplantation),
published in 2018, calls for psychosocial care and standardized self-management skills for
patients before, during, and in the long-term after VAD implantation. This is currently being
implemented inconsistently in terms of structure and quality in German cardiac centers. After
VAD implantation, patients and their relatives must be able to follow a complex therapeutic
regimen. They need comprehensive knowledge as well as self-management skills for the safe
management of everyday life in a domestic setting. These self-management capabilities include
the so-called device handling (for example dealing with the technical equipment including
battery replacement and controller monitoring), to perform the wound care of the driveline,
to carry out anticoagulation measurements and adapted revenues of oral anticoagulant, to take
further medication, to monitor vital signs (for example blood pressure, temperature) and, in
the case of symptoms, to take adequate measures to prevent further complications (for example
prompt information from the heart center on the onset of symptoms). In addition, lifestyle
changes are an essential part of the success of long-term therapy. This requires a sufficient
degree of self-management ability and mental stability. In addition, it is important to
emotionally accept the dependence of a device on the heart, the changed body image, to cope
with fears of (real potential) malfunctions and complications and to build up a subjective
quality of life with a constant, visible and tangible companion at heart. The mental health
of all those affected is considered to be in need of observation, although there is currently
no reliable prevalence data on mental disorders. In a first survey in 2006, 64% had at least
one psychologically / psychiatric treatment requiring diagnosis. All this shows, the
challenges VAD patients have to face are complex. Thus, this study aims to provide
multi-centered actual analysis of self-management capabilities as well as analyzing
moderating predictors in VAD patients through standardized PRO prevalence assessment. The
prevalence survey should be conducted in all outpatients (at least 3 months up to a maximum
of 3 years at the VAD) in four established German cardiac centers (Freiburg, Berlin, Bad
Oeynhausen, Leipzig). The study focuses on those involved in outpatient care, as they had to
integrate the VAD into their daily lives after implantation and are able to report deficits,
resources and needs on the basis of their experience of self-management. As an assessment
instrument a standardized PRO measure was chosen to identify self-management skills and
needs. Secondary PRO measures include health-related quality of life, symptoms of anxiety,
depression and post-traumatic stress, as well as social support. 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. The study is planned to continue in a second and
third phase to develop and test a standardized self-management care for VAD patients in
Germany.
