Clinical trial NCT02799810: Psychosocial Evaluation Prior to Lung Transplantation
Official title: Standardized Evaluation of Psychosocial Functioning in Patients Awaiting Lung Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Transplantation
Psychosomatic Medicine
Keywords: lung transplantation
psychosocial functioning
longitudinal
TERS
adherence
Quality of life
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting for evaluation at the interdisciplinary lung transplant outpatient clinic of Hannover Medical School or already listed for lung Transplantation and being in Treatment at Hannover Medical School

Brief summary: 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: change in survival status after lung transplantation
timeFrame: assessments at 1, 3, 6 and 12 month after lung transplantation
Secondary outcomes:
measure: duration of hospitalization after lung transplantation
timeFrame: assessments at 1, 3, 6 and 12 month after lung transplantation
measure: change in adherence during the first post-operative year
timeFrame: assessments at 1, 3, 6 and 12 month after lung transplantation
measure: change from baseline quality of life to one year post-transplantation
timeFrame: once before admission to waiting list and 12 month after lung transplantation
measure: change in quality of life during first post-operative year
timeFrame: 1, 3, 6 and 12 month after lung transplantation
measure: change from baseline psychological distress (questionnaire) to one year post-transplantation
timeFrame: once before admission to waiting list and 12 month after lung transplantation
measure: change in psychological distress (questionnaire) during first post-operative year
timeFrame: 1, 3, 6 and 12 month after lung transplantation
measure: mental disorders
timeFrame: 12 month after lung transplantation
measure: integration of transplant in own Body Image (questionnaire)
timeFrame: 12 month after lung transplantation
measure: psychological interventions
timeFrame: 12 month after lung transplantation
measure: psychotropic medication
timeFrame: 12 month after lung transplantation
measure: change from baseline comorbidity to one year post-Transplantation (clinical Rating)
timeFrame: once before admission to waiting list and 12 month after lung transplantation
measure: Change in comorbidity (clinical Rating)
timeFrame: 1, 3, 6 and 12 month after lung transplantation
Other outcomes:
Locations:
Study officials:
affiliation: Hannover Medical School
name: Martina de Zwaan, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Jens Gottlieb, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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