N/A
Completed N=258
Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial
Spina Bifida · Chronic Kidney Disease
Source: ClinicalTrials.gov NCT03045276 ↗
Enrolled (actual)
258
Serious AEs
25.6%
Results posted
Nov 2023
Primary outcomePrimary: Mean Percentage of Subjects With Adherence Behavior Greater Than or Equal to 85% From Baseline and Intervention Period (6-month) — 30.56; 42.04; 6.39; 12.14 percentage of subjects
Summary
The purpose of this study is to determine the effectiveness of behavioral feedback plus economic incentives to promote treatment adherence among a large diverse population of adolescents and young adults (AYA) with kidney transplant (KT) or spina bifida (SB).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percentage of Subjects With Adherence Behavior Greater Than or Equal to 85% From Baseline and Intervention Period (6-month) |
30.56; 42.04; 6.39; 12.14 | — |
| PRIMARY Study Efficacy of Use of Way to Health Portal System |
— | — |
| SECONDARY Change in Pressure Per Unit Volume of Bladder of Spina Bifida Subjects |
— | — |
| SECONDARY Change in Coefficient of Variation (CV) of Immunosuppressive Drug Levels (Tacrolimus or Sirolimus) Between the Baseline (run-in) and Intervention Period. |
4.69; 0.25 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females age 12-24 years.
- Kidney Transplant subjects must be greater than 3 months post-transplant.
- Spina Bifida subjects must be able to perform Clean Intermittent Catheterization (CIC) as part of their treatment.
- Able to speak and read in English.
- Willing and able to provide informed assent or consent.
- Parental/guardian permission (informed consent) if appropriate.
Exclusion Criteria
- Unwilling to participate.
- Unable to speak or read in English.
- Unable to provide informed assent or consent.
- Severe cognitive impairment, as reported by treating team in recruiting clinic.
- On dialysis.
- Acquired post-transplant lymphoproliferative disease less than one year prior to enrollment
- Less than 3 months post-transplant.
- Unable to perform CIC.
- Prescribed Immunosuppressive medications once per day.
- Provider recommendations of CIC once per day
Data sourced from ClinicalTrials.gov (NCT03045276). 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.