N/A
Completed N=169
Intervention to Improve Adherence in Teen Kidney Transplant
Chronic Kidney Disease · Medication Adherence
Source: ClinicalTrials.gov NCT01356277 ↗
Enrolled (actual)
169
Serious AEs
32.9%
Results posted
Jul 2018
Primary outcomePrimary: Taking Adherence — 78; 68 % of days with 100% taking adherence — p=0.006
Summary
The broad aim of the proposed study is to improve medication adherence in adolescent kidney transplant recipients. The investigators hypothesize that a multi-component intervention will improve medication adherence in the adolescent kidney transplant population. The specific aims are to determine, in a randomized clinical trial, the efficacy of a structured, multi-component intervention in improving adherence to anti-rejection medications and graft outcomes, and to identify characteristics of healthcare systems that are independently associated with adherence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Taking Adherence |
78; 68 | 0.006 sig |
| PRIMARY Timing Adherence |
73; 61 | 0.003 sig |
| SECONDARY Standard Deviation (SD) of Tacrolimus Trough Levels |
1.6; 1.4 | 0.49 |
| SECONDARY Self-reported Taking Adherence |
98.3; 97.1 | 0.15 |
| SECONDARY Self-reported Timing Adherence |
95.0; 92.9 | 0.15 |
| SECONDARY Acute Rejection Rate |
1.06; 1.69 | 0.26 |
| SECONDARY Annualized Change in Estimated Glomerular Filtration Rate (eGFR) |
-2.3; -3.3 | .45 |
Eligibility Criteria
Inclusion Criteria
- Subjects age 11 - 24 years
- At least 3 months post kidney transplant
Exclusion Criteria
- Significant neurocognitive disabilities limiting the subject's ability to understand and participate on their own
- Unable to communicate in English or French (Montreal site)
- Unable to communicate in English (all other sites)
Data sourced from ClinicalTrials.gov (NCT01356277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.