NCT02799810

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 15, 2016

Status Verified

May 1, 2016

Enrollment Period

2.9 years

First QC Date

April 28, 2016

Last Update Submit

June 9, 2016

Conditions

Lung TransplantationPsychosomatic Medicine

Keywords

lung transplantationpsychosocial functioninglongitudinalTERSadherenceQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (12)

  • duration of hospitalization after lung transplantation

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

  • change in adherence during the first post-operative year

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

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

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

  • change in quality of life during first post-operative year

    1, 3, 6 and 12 month after lung transplantation

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

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

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

    PMID: 3558716BACKGROUND

  • 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.

    PMID: 10109801BACKGROUND

  • 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.

    PMID: 26549304BACKGROUND

  • 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.

    PMID: 19171083BACKGROUND

  • 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.

    PMID: 20562734BACKGROUND

  • 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.

    PMID: 19616305BACKGROUND

  • 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.

    PMID: 12377839BACKGROUND

  • 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.

    PMID: 24233282BACKGROUND

  • 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)

    BACKGROUND

  • 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.

    PMID: 8456157BACKGROUND

  • 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.

    PMID: 26481959BACKGROUND

Study Officials

  • Martina de Zwaan, Prof. Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

  • Jens Gottlieb, Prof. Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2016

First Posted

June 15, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 15, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share