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Lung TransplantationEVALUTNCT02799810

Psychosocial Evaluation Prior to Lung Transplantation

An observational study of Lung Transplantation and Psychosomatic Medicine, run by Hannover Medical School.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Transplantation, Psychosomatic Medicine
How many people
200 participants
Where
No sites listed yet
Study dates
Jan 2016to Dec 2018
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Standardized Evaluation of Psychosocial Functioning in Patients Awaiting Lung Transplantation

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

Read the 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
Keywords
lung transplantation, psychosocial functioning, longitudinal, TERS, adherence, Quality of life

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in survival status after lung transplantation

    number of days survived during first post-operative year

    Measured: assessments at 1, 3, 6 and 12 month after lung transplantation

Secondary outcomes (12)

  1. duration of hospitalization after lung transplantation

    number of days of hospitalization during first post-operative year

    Measured: assessments at 1, 3, 6 and 12 month after lung transplantation

  2. 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

    Measured: assessments at 1, 3, 6 and 12 month after lung transplantation

  3. change from baseline quality of life to one year post-transplantation

    Change in self-rated multidimensional quality of life

    Measured: once before admission to waiting list and 12 month after lung transplantation

  4. 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

    Measured: 1, 3, 6 and 12 month after lung transplantation

  5. change from baseline psychological distress (questionnaire) to one year post-transplantation

    change in levels of self-rated anxiety and depressive symptoms

    Measured: once before admission to waiting list and 12 month after lung transplantation

  6. 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

    Measured: 1, 3, 6 and 12 month after lung transplantation

  7. mental disorders

    number and kind of current mental disorders at one year after lung transplantation

    Measured: 12 month after lung transplantation

  8. integration of transplant in own Body Image (questionnaire)

    Quality of psychological processing of lung Transplantation and Feelings towards donor one year after lung transplantation

    Measured: 12 month after lung transplantation

  9. psychological interventions

    number and kind of psychosocial interventions during first post-operative year

    Measured: 12 month after lung transplantation

  10. psychotropic medication

    kind and intake of (new) psychotropic medication during first post-operative year

    Measured: 12 month after lung transplantation

  11. change from baseline comorbidity to one year post-Transplantation (clinical Rating)

    change in kind, number and degree of comorbid conditions

    Measured: once before admission to waiting list and 12 month after lung transplantation

  12. Change in comorbidity (clinical Rating)

    mean number and degree of comorbid conditions during first post-operative year

    Measured: 1, 3, 6 and 12 month after lung transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT02799810
Sponsor's protocol ID
DZL BREATH-EVALUT
Acronym
EVALUT
Status last verified
May 2016
First submitted
28 Apr 2016
Last updated
15 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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. doi: 10.1016/0021-9681(87)90171-8.

    PubMed 3558716

  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PubMed 10109801

  • Gazdag G, Horvath GG, Makara M, Ungvari GS, Gerlei Z. Predictive value of psychosocial assessment for the mortality of patients waiting for liver transplantation. Psychol Health Med. 2016 Jun;21(4):525-529. doi: 10.1080/13548506.2015.1109670. Epub 2015 Nov 7.

    PubMed 26549304

  • 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.

    PubMed 19171083

  • 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.

    PubMed 20562734

  • Lowe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, Schneider A, Brahler 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.

    PubMed 19616305

  • 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. doi: 10.1378/chest.122.4.1176.

    PubMed 12377839

  • Smith PJ, Blumenthal JA, Carney RM, Freedland KE, O'Hayer CVF, 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):604-611. doi: 10.1378/chest.12-2127.

    PubMed 24233282

  • 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.

    PubMed 8456157

  • 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.

    PubMed 26481959

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Transplantation and Psychosomatic Medicine, run by Hannover Medical School.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in survival status after lung transplantation (time frame: assessments at 1, 3, 6 and 12 month after lung transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02799810, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.

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