Psychosocial Evaluation Prior to Lung Transplantation (EVALUT)

Hannover Medical School (MHH)

Status: Unknown

Conditions: Psychosomatic Medicine; Lung Transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT02799810

DZL BREATH-EVALUT

Details and patient eligibility

About

In a prospective longitudinal cohort study we aim at investigating the extent to which pre-transplant psychosocial levels of functioning predict the medical and psychosocial outcomes of lung transplantation. There is evidence that e.g. persistently elevated depressive symptoms are associated with reduced survival after lung transplantation

Full description

There is ample evidence that there are high rates of anxiety and depression among patients with end-stage lung disease. In addition, psychological dysfunction and distress seem to be especially prevalent in patients awaiting lung transplantation. Even though patients benefit from the transplant procedure with respect to long-term health-related quality of life (HRQoL), they also face significant challenges in terms of psychosocial adjustment after the transplantation. There is evidence that e.g. persistently elevated depressive symptoms are associated with reduced survival after lung transplantation.

Currently, the screening process to help select among candidates for organ transplant typically involves considering a variety of psychosocial factors. However, it remains somewhat unclear which criteria are considered important in these evaluations, how differences in various aspects of psychosocial functioning are weighed in making the ultimate decision on the suitability of a patient for transplantation, and the extent to which pretransplant psychosocial characteristics predict the medical and psychosocial outcomes of the procedure. Standardized psychometric instruments with proven reliability and validity can prevent the danger of personal bias in the selection of candidates for transplantation. In addition, structured psychometric instruments can help to identify patients with multiple care needs and can support the development of psychosocial interventions designed to increase quality of life and to decrease the risk of a less favorable transplant outcome through modifying the factors that might place patients at risk.

In a longitudinal prospective cohort study, psychosocial functioning will be assessed at multiple time points both before and after lung transplantation. Assessment of psychosocial functioning will be conducted using a validated, structured interview which allows a comprehensive evaluation of the level of adjustment in 10 aspects of psychosocial functioning - the Transplant Evaluation Rating Scale (TERS) - and standardized self-report instruments. The TERS has shown to be an important and significant predictor of several facets of somatic and psychosocial outcomes e.g. in patients after liver transplantation, left ventricular assist device implantation, and hematopoietic stem cell transplantation.

For each patient, a face-to-face psychosomatic evaluation 1 year after Transplantation will take place during a routine clinical assessments at the Department of Respiratory Medicine.

The following outcome parameters will be assessed:

• Mental disorders (current)
• Psychological processing of lung transplantation (including organ integration and the patient's relationship with the donor, chronic stress/psychological distress and the emotional effects of transplantation/immunosuppression
• Return to work one year after lung transplantation
• Psychological interventions during the first postoperative year
• Intake of (new) psychotropic medication during the first postoperative year

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients listed for lung Transplantation (including combined Transplantation) or who are evaluated at the interdisciplinary lung transplant outpatient clinic
• regular post-transplant visits at the Department of Respiratory Medicine
• informed consent

Exclusion criteria

• Age below 18 years
• lacking German language skills
• severe cognitive disability
• re-do Transplantation
• colonization with pan- or multi-resistant organisms with Need for isolation