Quality of Life in Pancreas Transplantation

NCT03921593 | Unknown

• 1 other identifier: 18/SC/0385
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Quality of Life for individuals with Insulin Dependent Diabetes Mellitus (IDDM) can be severely impaired by acute and chronic complications of the disease. Solid organ pancreatic transplantation restores endocrine pancreatic function. However, it is also burdened by high perioperative morbidity and mortality. Clinical benefits and risks of this intervention have been extensively clarified, but our knowledge about quality of life gain, often mentioned among the assets of transplantation, is still limited. This study aims to quantify the impact of all forms of Solid Organ Pancreas Transplantation on quality of life (QOL).

Conditions

Diabetes Mellitus; Quality of Life

Keywords

quality of life; pancreas transplant

Outcome Measures

Primary Outcomes (4)

• Quantification of Quality of Life

  Completion of EQ-5D-5L questionnaire. Scoring rules Each Dimension has 5 possible levels: 1 no problems, 2 slight problems, 3 moderate problems, 4 severe problems, 5 and extreme problems. Each level corresponds to a 1-digit code: 1-2-3-4-5. The final score is a 5-digit code describing the responder health state. These numbers have no arithmetic properties and should not be used as cardinal scores. Each 5-digit combination correspond to a possible health state. A total of 3125 possible health states is defined in this way. For example, state 11111 indicates no problems on any of the 5 dimensions, while state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression.

  pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation

• Quantification of Quality of Life

  Completion of Diabetes Quality of Life questionnaire (DQOL) DQOL includes 46 core items forming four scales targeted at particular health-related concerns of individuals with Insulin Dependent Diabetes Mellitus, a generic health item that does not contribute to the scales Scoring rules Dimensions and DQoL total scores (average score across the 4 dimensions) are scored 0-100, where 0 is the lowest possible quality of life and 100 the highest.

  pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation

• Quantification of Quality of Life

  Completion of Kidney Disease Quality of Life Short Form questionnaire (KDQOL-SF) KDQOL-SFTM includes multi-item scales targeted at particular health-related concerns of individuals with kidney disease and generic scales derived from the short form 36 (SF-36),Scoring Rules 1\) Each possible response for each item corresponds to a pre-coded numeric value. 2) The raw pre-coded numeric values are transformed to a 0-100 range, with higher transformed scores reflecting better quality of life ( the lowest and highest possible scores are 0 and 100, respectively ). 3\) Items on the same scale are averaged to ether to create the scale scores. Items that are left blank are not take into account: the final score for each scale represents the average for all the items in that scale that the respondent answered.

  pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation

• Quantification of Quality of Life

  Completion of Short Form 12 v.2 questionnaire (SF-12 v.2®) includes 8 domains and 12 items that form two Components: Physical Health Component (PCS) and Mental Health Component (MCS) A computer-based scoring algorithm is used to calculate scores: Physical Component Summary (PCS) and Mental (MCS) Component Summary scales are generated using norm-based methods. Scores are transformed to have a mean value of 50, standard deviation (SD) 10, where scores above or below 50 are above or below average physical or mental well-being, respectively.

  pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation

Secondary Outcomes (2)

• Correlation between clinical status and quality of life pre-transplantation

  pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation

• Estimate cost-effectiveness of pancreas transplantation

  pre- transplant, 1 year

Study Arms (3)

Simultaneous Pancreas Kidney Transplant Recipients

Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Simultaneous Pancreas Kidney Transplant (SPK)

Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation

Pancreas after kidney Transplant Recipients

Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Pancreas after kidney Transplant (PAK)

Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation

Pancreas Transplant Alone Recipients

Patient affected by Insulin Dependent Diabetes Mellitus with hypoglycemia unawareness undergoing Pancreas Transplant Alone (PTA)

Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation

Interventions

Solid Organ Pancreas Transplantation with or without Kidney Transplantation PROCEDURE

Deceased donor pancreas transplantation

Pancreas Transplant Alone Recipients; Pancreas after kidney Transplant Recipients; Simultaneous Pancreas Kidney Transplant Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Insulin Dependent diabetic adult patients with either renal failure or hypoglycemia unawareness or both, active on Oxford transplant centre pancreas transplant waiting list and fluent in English

You may qualify if:

• Willing and able to give informed consent for participation in the study
• Insulin Dependent Diabetic Patients
• Active on Pancreas Transplant Wait List

You may not qualify if:

• Not fluent in English

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford University Hospital NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

RECRUITING

Related Publications (8)

• 1. Quality and Outcomes Framework (2014/15), Diabetes Prevalence Model 2016 (Public Health England) and 2012 APHO Diabetes Prevalence Model.

  BACKGROUND

• 2. Livingstone, S.J. et al (2015) Estimated Life Expectancy in a Scottish Cohort with Type 1 Diabetes, 2008-2010. JAMA 313(1) 37-44 78 Seshasai SR on behalf of the Emerging Risk Factors Collaboration (2011) Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 3;364(9):829-41

  BACKGROUND

• Diabetes mellitus: a major risk factor for cardiovascular disease. A joint editorial statement by the American Diabetes Association; The National Heart, Lung, and Blood Institute; The Juvenile Diabetes Foundation International; The National Institute of Diabetes and Digestive and Kidney Diseases; and The American Heart Association. Circulation. 1999 Sep 7;100(10):1132-3. doi: 10.1161/01.cir.100.10.1132. No abstract available.

  PMID: 10477541 BACKGROUND

• Liew G, Michaelides M, Bunce C. A comparison of the causes of blindness certifications in England and Wales in working age adults (16-64 years), 1999-2000 with 2009-2010. BMJ Open. 2014 Feb 12;4(2):e004015. doi: 10.1136/bmjopen-2013-004015.

  PMID: 24525390 BACKGROUND

• Dean PG, Kukla A, Stegall MD, Kudva YC. Pancreas transplantation. BMJ. 2017 Apr 3;357:j1321. doi: 10.1136/bmj.j1321.

  PMID: 28373161 BACKGROUND

• Taber DJ, Meadows HB, Pilch NA, Chavin KD, Baliga PK, Egede LE. Pre-existing diabetes significantly increases the risk of graft failure and mortality following renal transplantation. Clin Transplant. 2013 Mar-Apr;27(2):274-82. doi: 10.1111/ctr.12080. Epub 2013 Feb 6.

  PMID: 23383719 BACKGROUND

• Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.

  PMID: 26068866 BACKGROUND

• White SA, Shaw JA, Sutherland DE. Pancreas transplantation. Lancet. 2009 May 23;373(9677):1808-17. doi: 10.1016/S0140-6736(09)60609-7.

  PMID: 19465236 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Peter J Friend, MA, MB, FRCS, MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Mosca, MD

CONTACT

+44 01865 223-872; irene.mosca@nds.ox.ac.uk

Aimee stewart

CONTACT

+44 01865 223-872; aimee.stewart@nds.ox.ac.uk

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 17, 2019
• First Posted: April 19, 2019
• Study Start: November 4, 2018
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-07

Locations

GB (1)