Psychosocial Evaluation Prior to Lung Transplantation

Lung Transplantation Clinical Trial

— EVALUT  

Official title:

Standardized Evaluation of Psychosocial Functioning in Patients Awaiting Lung Transplantation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02799810
• Other study ID #: DZL BREATH-EVALUT
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 28, 2016
• Last updated: June 9, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2016
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Transplantation
• Psychosomatic Medicine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

References & Publications (11)

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. — View Citation

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

Gazdag G, Horváth GG, Makara M, Ungvari GS, Gerlei Z. Predictive value of psychosocial assessment for the mortality of patients waiting for liver transplantation. Psychol Health Med. 2015 Nov 7:1-5. [Epub ahead of print] — View Citation

Goetzmann L, Irani S, Moser KS, Schwegler K, Stamm M, Spindler A, Buddeberg C, Schmid C, Boehler A, Klaghofer R. Psychological processing of transplantation in lung recipients: a quantitative study of organ integration and the relationship to the donor. Br J Health Psychol. 2009 Nov;14(Pt 4):667-80. doi: 10.1348/135910708X399447. Epub 2009 Jan 24. — View Citation

Kugler C, Tegtbur U, Gottlieb J, Bara C, Malehsa D, Dierich M, Simon A, Haverich A. Health-related quality of life in long-term survivors after heart and lung transplantation: a prospective cohort study. Transplantation. 2010 Aug 27;90(4):451-7. doi: 10.1097/TP.0b013e3181e72863. — View Citation

Löwe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, Schneider A, Brähler E. A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population. J Affect Disord. 2010 Apr;122(1-2):86-95. doi: 10.1016/j.jad.2009.06.019. Epub 2009 Jul 17. — View Citation

Napolitano MA, Babyak MA, Palmer S, Tapson V, Davis RD, Blumenthal JA; Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE) Investigators. Effects of a telephone-based psychosocial intervention for patients awaiting lung transplantation. Chest. 2002 Oct;122(4):1176-84. — View Citation

Smith PJ, Blumenthal JA, Carney RM, Freedland KE, O'Hayer CV, Trulock EP, Martinu T, Schwartz TA, Hoffman BM, Koch GG, Davis RD, Palmer SM. Neurobehavioral functioning and survival following lung transplantation. Chest. 2014 Mar 1;145(3):604-11. doi: 10.1378/chest.12-2127. — View Citation

Speckhart D, Solomon SR, Zhang X, Morris LE, Bashey A, Holland HK. The Psychosocial Transplant Evaluation Rating Scale (TERS) prospectively predicts inferior Overall survival outcome for high-risk scoring patients undergoing allogeneic hematopoietic stem cell Transplantation. Blood 2014; 124(21)

Twillman RK, Manetto C, Wellisch DK, Wolcott DL. The Transplant Evaluation Rating Scale. A revision of the psychosocial levels system for evaluating organ transplant candidates. Psychosomatics. 1993 Mar-Apr;34(2):144-53. — View Citation

Yost GL, Bhat G, Ibrahim KN, Karountzos AG, Chandrasekaran M, Mahoney E. Psychosocial Evaluation in Patients Undergoing Left Ventricular Assist Device Implantation Using the Transplant Evaluation Rating Scale. Psychosomatics. 2016 Jan-Feb;57(1):41-6. doi: 10.1016/j.psym.2015.07.013. Epub 2015 Aug 1. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in survival status after lung transplantation	number of days survived during first post-operative year	assessments at 1, 3, 6 and 12 month after lung transplantation	No
Secondary	duration of hospitalization after lung transplantation	number of days of hospitalization during first post-operative year	assessments at 1, 3, 6 and 12 month after lung transplantation	No
Secondary	change in adherence during the first post-operative year	mean composite adherence score to immunosuppressants (IS) based on multiple clinical ratings and IS trough levels during first post-operative year	assessments at 1, 3, 6 and 12 month after lung transplantation	No
Secondary	change from baseline quality of life to one year post-transplantation	Change in self-rated multidimensional quality of life	once before admission to waiting list and 12 month after lung transplantation	No
Secondary	change in quality of life during first post-operative year	mean self-rated multidimensional quality of life based on multiple assessments during first post-operative year	1, 3, 6 and 12 month after lung transplantation	No
Secondary	change from baseline psychological distress (questionnaire) to one year post-transplantation	change in levels of self-rated anxiety and depressive symptoms	once before admission to waiting list and 12 month after lung transplantation	No
Secondary	change in psychological distress (questionnaire) during first post-operative year	mean levels of self-rated anxiety and depressive symptoms based on multiple assessments during first post-operative year	1, 3, 6 and 12 month after lung transplantation	No
Secondary	mental disorders	number and kind of current mental disorders at one year after lung transplantation	12 month after lung transplantation	No
Secondary	integration of transplant in own Body Image (questionnaire)	Quality of psychological processing of lung Transplantation and Feelings towards donor one year after lung transplantation	12 month after lung transplantation	No
Secondary	psychological interventions	number and kind of psychosocial interventions during first post-operative year	12 month after lung transplantation	No
Secondary	psychotropic medication	kind and intake of (new) psychotropic medication during first post-operative year	12 month after lung transplantation	No
Secondary	change from baseline comorbidity to one year post-Transplantation (clinical Rating)	change in kind, number and degree of comorbid conditions	once before admission to waiting list and 12 month after lung transplantation	No
Secondary	Change in comorbidity (clinical Rating)	mean number and degree of comorbid conditions during first post-operative year	1, 3, 6 and 12 month after lung transplantation	No