Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial (U-REAACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03045276|
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spina Bifida Kidney Transplant||Behavioral: Behavioral Feedback and Economic Incentives: Arm 1 Behavioral: Behavioral Feedback and Economic Incentives: Arm 2||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial|
|Actual Study Start Date :||June 29, 2017|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2023|
Active Comparator: Arm 1 - No Feedback, Minimum Incentive
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.
Behavioral: Behavioral Feedback and Economic Incentives: Arm 1
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.
Active Comparator: Arm 2 - Feedback, Maximum Incentive
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.
Behavioral: Behavioral Feedback and Economic Incentives: Arm 2
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.
- Adherence [ Time Frame: 12.5 months ]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 [ Time Frame: 12.5 months ]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.
- Change in pressure per unit volume of bladder of Spina Bifida subjects [ Time Frame: 12.5 months ]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. [ Time Frame: 12.5 months ]Immunosuppressive drug levels in kidney transplant
- Executive Function [ Time Frame: 12.5 months ]Behavior Rating Inventory of Executive Function questionnaire will be administered and answers will be analyzed.
- Perceived Treatment Barriers - Spina Bifida [ Time Frame: 12.5 months ]The Spina Bifida and Cathing Barriers measure will be administered and answers will be analyzed.
- Perceived Treatment Barriers -Kidney Transplant [ Time Frame: 12.5 months ]The Adolescent Medication Barrier Scale will be administered and answers will be analyzed.
- Self-Efficacy [ Time Frame: 12.5 months ]Self-Efficacy for Managing Chronic Disease 6-item scale will be administered and answers will be analyzed
- Treatment Responsibility [ Time Frame: 12.5 months ]Allocation of Treatment Responsibility and the Sharing of Spina Bifida Management Responsibilities surveys will be administered and answers will be analyzed.
- Disease/Transplant Knowledge [ Time Frame: 12.5 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045276
|Contact: Sandra Amaral, MD, MHSfirstname.lastname@example.org|
|Contact: Janaiya Reason, MPH||12673341336||Reasonj@email.chop.edu|
|United States, Georgia|
|Children's Healthcare of Atlanta||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Saadia Khizer, MBBS, MPH 404-785-9893 Saadia.email@example.com|
|Principal Investigator: Roshan George|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Mohammad Alkhawaldeh Mohammad.Alkhawaldeh@childrens.harvard.edu|
|Principal Investigator: Carlos Estrada|
|United States, Missouri|
|Children's Mercy Hospital||Recruiting|
|Kansas City, Missouri, United States, 64108|
|Contact: Janelle Jennings firstname.lastname@example.org|
|Principal Investigator: Bradley Warady|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Janaiya Reason, BS, MPH 267-425-3934 email@example.com|
|Principal Investigator: Sandra Amaral, MD, MHS|
|Principal Investigator:||Sandra Amaral, MD, MHS||Children's Hospital of Philadelphia|