Living-donor kidney transplantation Urological and Genital Diseases
Conditions
Interventions
This trial is a two-arm, parallel group, pragmatic, individually randomized, controlled, type 1 hybrid effectiveness trial of a patient and family outreach service to improve access to living-donor ki
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (age >= 18 years) 2.1. Have been referred for/are being assessed for kidney-only transplant listing Or 2.2. Are active on the UK kidney only transplant waiting list
Exclusion criteria
Exclusion criteria: 1. Active malignancy 2. Signs or symptoms of active cardiac disease (e.g. angina, arrhythmia, New York Heart Association functional class 3/4 heart disease, symptomatic valvular heart disease) 3. Chronic intractable systemic infection 4. Active substance addiction/misuse 5. Body mass index (BMI) >=40 kg/m2 6. A transplant MDT expectation that they are unlikely to be suitable for transplantation following pending investigations (e.g., cardiopulmonary) 7. A potential living kidney donor undergoing surgical assessment or approved for kidney donation 8. Been registered on the UK transplant wait list for multiple organ transplant, e.g. simultaneous pancreas kidney or simultaneous liver kidney transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who receive a living-donor kidney transplant (LDKT) within 18 months of randomisation (excluding LDKTs from non-directed altruistic donors outside the sharing scheme) at 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to receipt of a LDKT (excluding LDKT if from a non-directed altruistic donor outside the sharing scheme) measured at 18 months 2. Probability of receiving an LDKT as estimated by Kaplan-Meier methods at 18 months 3. Transplant candidates with at least one donor at each stage of assessment: 3.1. Initial evaluation by coordinators completed 3.2. Nephrological assessment completed 3.3. Surgical assessment completed 3.4. Registered to UK Living Donor Sharing Scheme (if applicable, and reason for entry into sharing scheme, e.g., ABO blood group incompatible [ABOi], Human Leukocyte Antigen [HLA] incompatible [HLAi], better match required) 3.5. Donated/date set for donation 4. Total number and % in each stage Descriptive statistics for the number of donors per recipient registered to the UK Living Donor Sharing Scheme, with reasons will be presented. Patient self-reported total number of donors at any of the above stages 3.1-3.4. Measured at 18 months 5. Patient activation measured using the Patient Activation Measure-13 (PAM-13). Mean PAM score (0-100) and number and % of each PAM level (1-4) at baseline and 4 months 6. Perceived social support measured using Interpersonal Support Evaluation List-12 (ISEL-12). Mean total ISEL-12 score (/36) at baseline and 4 months 7. LDKT knowledge measured using the Rotterdam Renal Replacement Knowledge-Test (R3K-T). Mean total R3K-T score (/11) at baseline and 4 months 8. Quality of life measured using EQ-5D-5L. Mean EQ-5D-5L index value and mean EQ-VAS score (/100) at baseline and 4, 9 and 18 months 9. Adherence measured at 4 months: Intervention group: 9.1. Participants who have first intervention meeting (number and %) 9.2. Participants who have letters sent to family/friends (and number of letters sent per participant) (number and %) 9.3. Participants receiving home visits by intervention team (and number of home visits per participant) (number and %) 9.4. Content compliance (quantitative checklist for home | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactViona Rundell
Outcome results
None listed