Clinical trial NCT03045276: Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial
Official title: Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spina Bifida
Kidney Transplant
Keywords: Spina Bifida
Kidney Transplant
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Boston Children's Hospital
name: Children's Healthcare of Atlanta
name: Children's Mercy Hospital Kansas City
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Seattle Children's Hospital
First posted: 2017-02-07
Enrollment: 465
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed description: The overarching goal of this five-year, phase II, randomized clinical trial is to improve poor long-term health outcomes in both adolescents and young adults (AYA) with either a kidney transplant (KT) or spina bifida (SB), respectively. More specifically, this study will focus on decreasing premature allograft loss in subjects with kidney transplant (KT) due to medication nonadherence and kidney damage in subjects with SB due to urinary non-continence. To achieve these goals, this study will implement a real-time feedback system, Way to Health (WTH), that will provide education and support, increase awareness and incentivize positive health behavior, in addition to standard of care. Further, this study will investigate the mechanisms of behavior change by examining the role of financial incentives, positive feedback and the relationship between the two. The study will compare two cohorts of KT and SB subjects, which will undergo varied levels of financial incentives and positive feedback. Data from KT and SB subjects will be analyzed jointly and separately. This innovative mobile health (mhealth) strategy will improve our current measures of adherence and increase our understanding of factors that influence adherence for two AYA populations, KT and SB subjects, respectively. The study will contribute novel insight to inform the design of future interventions targeting persistence of behavior change and can be used in other centers and for other chronic disease groups.

The study intervention will use the WTH web-based platform to support AYA with KT or SB as they navigate their daily treatment burdens. This will be achieved via bi-directional text messaging, including the sending of reminders and positive feedback by WTH and the messaging of pictures of medication or catheter in hand at time of treatment by the participant. This intervention will assess sustainability of this novel bi-directional messaging system and the impact of providing education and support, increasing awareness and incentivizing positive health behavior in real-time.

Eligibility criteria: Inclusion Criteria:

1. Males or females age 12-24 years.
2. Kidney Transplant subjects must be greater than 3 months post-transplant.
3. Spina Bifida subjects must be able to perform Clean Intermittent Catheterization (CIC) as part of their treatment.
4. Able to speak and read in English.
5. Willing and able to provide informed assent or consent.
6. Parental/guardian permission (informed consent) if appropriate.

Exclusion Criteria:

1. Unwilling to participate.
2. Unable to speak or read in English.
3. Unable to provide informed assent or consent.
4. Severe cognitive impairment, as reported by treating team in recruiting clinic.
5. On dialysis.
6. Acquired post-transplant lymphoproliferative disease less than one year prior to enrollment
7. Less than 3 months post-transplant.
8. Unable to perform CIC.
9. Prescribed Immunosuppressive medications once per day.
10. Provider recommendations of CIC once per day

Primary outcomes:
measure: Mean Percentage of Subjects With Adherence Behavior Greater Than or Equal to 85% From Baseline and Intervention Period (6-month)
timeFrame: baseline to 6 months
measure: Study Efficacy of Use of Way to Health Portal System
timeFrame: 12.5 months
Secondary outcomes:
measure: Change in Pressure Per Unit Volume of Bladder of Spina Bifida Subjects
timeFrame: 12.5 months
measure: Change in Coefficient of Variation (CV) of Immunosuppressive Drug Levels (Tacrolimus or Sirolimus) Between the Baseline (run-in) and Intervention Period.
timeFrame: baseline and at 6 months
Other outcomes:
measure: Executive Function
timeFrame: 12.5 months
measure: Perceived Treatment Barriers - Spina Bifida
timeFrame: 12.5 months
measure: Mean Change in Perceived Adherence Behaviors as Measured by the Adolescent Medication Barriers Scale From Baseline to Intervention Period (6 Months)
timeFrame: Baseline to 6 months
measure: Change in Self-Efficacy Score From Baseline to Intervention Period (6 Month)
timeFrame: baseline to 6 months
measure: Treatment Responsibility
timeFrame: 12.5 months
measure: Change in Disease Knowledge Score From Baseline to Intervention (6 Months)
timeFrame: baseline to 6 months
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Sandra Amaral, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: