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Quality of Life in Pancreas Transplantation

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ClinicalTrials.gov Identifier: NCT03921593
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date April 17, 2019
First Posted Date April 19, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date November 4, 2018
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2019)
  • Quantification of Quality of Life [ Time Frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation ]
    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.
  • Quantification of Quality of Life [ Time Frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation ]
    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.
  • Quantification of Quality of Life [ Time Frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation ]
    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.
  • Quantification of Quality of Life [ Time Frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation ]
    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.
Original Primary Outcome Measures
 (submitted: April 18, 2019)
  • Quantification of Quality of Life pre-transplantation [ Time Frame: pre transplantation ]
    Completion of Quality of Life Questionnaires
  • Quantification of Quality of Life post-transplantation [ Time Frame: 6 weeks ]
    Completion of Quality of Life Questionnaires
  • Quantification of Quality of Life post-transplantation [ Time Frame: 6 months ]
    Completion of Quality of Life Questionnaires
  • Quantification of Quality of Life post-transplantation [ Time Frame: 1 year ]
    Completion of Quality of Life Questionnaires
Change History Complete list of historical versions of study NCT03921593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 10, 2019)
  • Correlation between clinical status and quality of life pre-transplantation [ Time Frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation ]
    Identification of which clinical phenotypes correspond to higher quality of life scores collection of clinical data at the same time points as quality of life questionnaires to establish correlation/causal effect between clinical and qol data
  • Estimate cost-effectiveness of pancreas transplantation [ Time Frame: pre- transplant, 1 year ]
    calculation of Quality Adjusted Life Years (QALYs) As per NICE recommendation, utility scores derived by EQ5D5L will be used to calculate Quality Adjusted Life Years before transplantation and at one year from transplant to calculate QALY gain after pancreas transplantation
Original Secondary Outcome Measures
 (submitted: April 18, 2019)
  • Correlation between clinical status and quality of life pre-transplantation [ Time Frame: pre-transplantation ]
    Identification of which clinical phenotypes correspond to higher quality of life scores
  • Correlation between clinical status and quality of life post-transplantation [ Time Frame: 6 weeks ]
    Identification of which clinical phenotypes correspond to higher quality of life scores
  • Correlation between clinical status and quality of life post-transplantation [ Time Frame: 6 months ]
    Identification of which clinical phenotypes correspond to higher quality of life scores
  • Correlation between clinical status and quality of life post-transplantation [ Time Frame: 1 year ]
    Identification of which clinical phenotypes correspond to higher quality of life scores
  • Estimate cost-effectiveness of pancreas transplantation [ Time Frame: pre-transplant ]
    calculation of Quality Adjusted Life Years (QALYs)
  • Estimate cost-effectiveness of pancreas transplantation [ Time Frame: 1 year ]
    calculation of Quality Adjusted Life Years (QALYs)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life in Pancreas Transplantation
Official Title Prospective Longitudinal Observational Study on Insulin Dependent Diabetic Patients Undergoing Any Form of Solid Organ Pancreas Transplantation Aimed to Clarify Quality of Life Changes After Pancreas Transplantation
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).

Detailed Description

Rationale of the study:

There are 3.5 million people in the United Kingdom diagnosed with diabetes. Their life expectancy is significantly reduced when compared to non-diabetic population. The long standing poor metabolic control causes a cluster of complications such as metabolic instability, cardiovascular disease, nephropathy, retinopathy and neuropathy which have a major impact on the clinical and social wellbeing of these individuals.

Solid organ pancreatic transplantation restores endocrine pancreatic function, but it is still burdened by significant perioperative morbidity and mortality.

There are other less invasive transplant options we can offer to this cohort of patients. The most common are Kidney Transplant Alone (KTA) from deceased or living donor in the diabetic and uremic patients and Islets Transplant (IT) for those with hypoglycemia unawareness and preserved renal function.

Although current literature suggests that the less invasive approaches may be less effective in the long term, potentially they could resolve the most compelling clinical needs at a lower surgical risk.

There is now a general consensus that the surgical risks of pancreatic solid organ transplantation must be weighed against clinical outcomes as well as QOL gain

Aims of the study:

This study aims to quantify QOL trajectory pre- and post- pancreas transplantation and identify correlations between QOL and clinical outcomes. The data collected will be utilized to understand which forms of solid organ pancreas transplantation are associated with greater/ lesser QOL gain and to compute a cost effectiveness analysis of this intervention.

Methods:

The core of the study will be a prospective quasi-experimental design focusing on QOL outcomes for patients on the pancreas transplant waiting-list at Oxford University Transplant Centre.

Patients active on the Oxford Transplant Centre Pancreas Transplant Waiting list will be invited to take part to this study.

Participants will be requested to complete one set of validated generic and disease specific (diabetes and kidney failure where applicable) QOL questionnaires pre-transplantation and at three time points post-transplantation: 6 weeks, 6 months and 1 year. The research team will collect clinical and hospital usage data at the same time points.

At the end of data collection, statistical analysis will aim to discern overall QOL changes in terms of Quality Adjusted Life Years (QALY), but also whether different cohorts of pancreas transplant recipients (SPK, PAK, and PTA) have different QOL outcomes and in which domains of QOL they differ.

A cohort of patients who receive a PT will be matched to a cohort of patients who remain on the PT waiting-list. Matching estimators, including Propensity Score and Coarsened Exact Matching, will be used to achieve covariate balance between the synthetic treated and control groups in order to estimate the causal effect of QoL changes post-transplantation.

Cumulative hospital costs of care by treatment group will be analysed using appropriate regression methods for non-normal, continuous outcomes. Continuous QOL outcomes will be analysed using generalised linear models.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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
Condition
  • Diabetes Mellitus
  • Quality of Life
Intervention Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation
Deceased donor pancreas transplantation
Study Groups/Cohorts
  • Simultaneous Pancreas Kidney Transplant Recipients
    Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Simultaneous Pancreas Kidney Transplant (SPK)
    Intervention: 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)
    Intervention: 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)
    Intervention: Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 18, 2019)
110
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 7, 2021
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not fluent in English
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Irene Mosca, MD +44 01865 223-872 irene.mosca@nds.ox.ac.uk
Contact: Aimee stewart +44 01865 223-872 aimee.stewart@nds.ox.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03921593
Other Study ID Numbers 18/SC/0385
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Oxford
Study Sponsor University of Oxford
Collaborators Not Provided
Investigators
Principal Investigator: Peter J Friend, MA, MB, FRCS, MD University of Oxford
PRS Account University of Oxford
Verification Date April 2019