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Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial (U-REAACT)

Primary Purpose

Spina Bifida, Kidney Transplant

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Feedback and Economic Incentives: Arm 1
Behavioral Feedback and Economic Incentives: Arm 2
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spina Bifida focused on measuring Spina Bifida, Kidney Transplant

Eligibility Criteria

12 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Healthcare of Atlanta
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Boston Children's Hospital
  • Children's Mercy Hospital
  • The Children's Hospital of Philadelphia
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1 - No Feedback, Minimum Incentive

Arm 2 - Feedback, Maximum Incentive

Arm Description

Subjects will receive daily text message reminders and report real-time treatment adherence with photos. They will receive compensation to encourage real-time adherence reporting. Subjects will also be able to log into a personal dashboard with a visual display of their weekly adherence performance and educational resources related to their primary disease. Every month, participants will receive a text encouraging them to visit their personal dashboard. The dashboard is able to track usage of the modules by individual. Parents/legal guardians will have access to these same educational materials via their own portals. Additionally, to mitigate the minimal risk of this study, parents/legal guardians will be notified if their child is excessively non-adherent.

Subjects will receive daily text message reminders and report real-time treatment adherence with photos, and will have web access to the educational modules through their portal. Every month, participants will receive a text encouraging them to visit their portals. In contrast to Arm 1, they will receive their weekly performance results by text to their phone with tailored feedback. In Arm 2, subjects will receive a larger incentive if they perform their desired treatment behavior. Incentive notification will be texted to participants. Similarly to Arm 1, parents/legal guardians will have access to the same educational materials via their own WTH portals. Additionally, to mitigate the minimal risk of this study, parents/legal guardians will be notified if their child is excessively non-adherent.

Outcomes

Primary Outcome Measures

Adherence
Statistical analysis of the number and timing of messages sent to the Way to Health portal will determine adherence.
Study Efficacy of use of Way to Health Portal system
Statistical analysis of the number and timing of messages sent to the Way to Health portal as well as how often the participants used the portal will determine study efficacy.

Secondary Outcome Measures

Change in pressure per unit volume of bladder of Spina Bifida subjects
Urodynamic studies (UDS) in spina bifida subjects will test the change in bladder wall compliance, i.e. the change in pressure per unit volume of the bladder.
Change in Coefficient of Variation (CV) of immunosuppressive drug levels (tacrolimus or sirolimus) between the baseline (run-in) and intervention period.
Immunosuppressive drug levels in kidney transplant

Full Information

First Posted
January 31, 2017
Last Updated
May 16, 2022
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Boston Children's Hospital, Children's Healthcare of Atlanta, Children's Mercy Hospital Kansas City, Ann & Robert H Lurie Children's Hospital of Chicago, Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03045276
Brief Title
Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial
Acronym
U-REAACT
Official Title
Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
April 9, 2022 (Actual)
Study Completion Date
April 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Boston Children's Hospital, Children's Healthcare of Atlanta, Children's Mercy Hospital Kansas City, Ann & Robert H Lurie Children's Hospital of Chicago, Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida, Kidney Transplant
Keywords
Spina Bifida, Kidney Transplant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
465 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - No Feedback, Minimum Incentive
Arm Type
Active Comparator
Arm Description
Subjects will receive daily text message reminders and report real-time treatment adherence with photos. They will receive compensation to encourage real-time adherence reporting. Subjects will also be able to log into a personal dashboard with a visual display of their weekly adherence performance and educational resources related to their primary disease. Every month, participants will receive a text encouraging them to visit their personal dashboard. The dashboard is able to track usage of the modules by individual. Parents/legal guardians will have access to these same educational materials via their own portals. Additionally, to mitigate the minimal risk of this study, parents/legal guardians will be notified if their child is excessively non-adherent.
Arm Title
Arm 2 - Feedback, Maximum Incentive
Arm Type
Active Comparator
Arm Description
Subjects will receive daily text message reminders and report real-time treatment adherence with photos, and will have web access to the educational modules through their portal. Every month, participants will receive a text encouraging them to visit their portals. In contrast to Arm 1, they will receive their weekly performance results by text to their phone with tailored feedback. In Arm 2, subjects will receive a larger incentive if they perform their desired treatment behavior. Incentive notification will be texted to participants. Similarly to Arm 1, parents/legal guardians will have access to the same educational materials via their own WTH portals. Additionally, to mitigate the minimal risk of this study, parents/legal guardians will be notified if their child is excessively non-adherent.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Feedback and Economic Incentives: Arm 1
Intervention Description
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 transplants (KT) or spina bifida (SB). In Arm 1, participants will not receive personalized feedback, nor will they receive the "extra" incentive of $10 for meeting their adherence goal.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Feedback and Economic Incentives: Arm 2
Intervention Description
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 transplants (KT) or spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.
Primary Outcome Measure Information:
Title
Adherence
Description
Statistical analysis of the number and timing of messages sent to the Way to Health portal will determine adherence.
Time Frame
12.5 months
Title
Study Efficacy of use of Way to Health Portal system
Description
Statistical analysis of the number and timing of messages sent to the Way to Health portal as well as how often the participants used the portal will determine study efficacy.
Time Frame
12.5 months
Secondary Outcome Measure Information:
Title
Change in pressure per unit volume of bladder of Spina Bifida subjects
Description
Urodynamic studies (UDS) in spina bifida subjects will test the change in bladder wall compliance, i.e. the change in pressure per unit volume of the bladder.
Time Frame
12.5 months
Title
Change in Coefficient of Variation (CV) of immunosuppressive drug levels (tacrolimus or sirolimus) between the baseline (run-in) and intervention period.
Description
Immunosuppressive drug levels in kidney transplant
Time Frame
12.5 months
Other Pre-specified Outcome Measures:
Title
Executive Function
Description
Behavior Rating Inventory of Executive Function questionnaire will be administered and answers will be analyzed.
Time Frame
12.5 months
Title
Perceived Treatment Barriers - Spina Bifida
Description
The Spina Bifida and Cathing Barriers measure will be administered and answers will be analyzed.
Time Frame
12.5 months
Title
Perceived Treatment Barriers -Kidney Transplant
Description
The Adolescent Medication Barrier Scale will be administered and answers will be analyzed.
Time Frame
12.5 months
Title
Self-Efficacy
Description
Self-Efficacy for Managing Chronic Disease 6-item scale will be administered and answers will be analyzed
Time Frame
12.5 months
Title
Treatment Responsibility
Description
Allocation of Treatment Responsibility and the Sharing of Spina Bifida Management Responsibilities surveys will be administered and answers will be analyzed.
Time Frame
12.5 months
Title
Disease/Transplant Knowledge
Description
The Heart Transplant Knowledge questionnaire, adapted for Kidney Transplant patients, and the Knowledge of Spina Bifida survey will be administered and answers will be analyzed.
Time Frame
12.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Amaral, MD, MHS
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not share individual participant data beyond those involved in the research study.

Learn more about this trial

Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial

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