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Trial record 39 of 49 for:    Recruiting, Not yet recruiting, Available Studies | kidney disease | NIDDK

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

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ClinicalTrials.gov Identifier: NCT03045276
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : September 5, 2019
Sponsor:
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
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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).

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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


Other Outcome Measures:
  1. Executive Function [ Time Frame: 12.5 months ]
    Behavior Rating Inventory of Executive Function questionnaire will be administered and answers will be analyzed.

  2. 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.

  3. Perceived Treatment Barriers -Kidney Transplant [ Time Frame: 12.5 months ]
    The Adolescent Medication Barrier Scale will be administered and answers will be analyzed.

  4. Self-Efficacy [ Time Frame: 12.5 months ]
    Self-Efficacy for Managing Chronic Disease 6-item scale will be administered and answers will be analyzed

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045276


Contacts
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Contact: Sandra Amaral, MD, MHS 267-844-3097 amarals@email.chop.edu
Contact: Janaiya Reason, MPH 12673341336 Reasonj@email.chop.edu

Locations
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United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Saadia Khizer, MBBS, MPH    404-785-9893    Saadia.khizer@choa.org   
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       jjennings@cmh.edu   
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    reasonj@email.chop.edu   
Principal Investigator: Sandra Amaral, MD, MHS         
Sponsors and Collaborators
Children's Hospital of Philadelphia
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
Investigators
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Principal Investigator: Sandra Amaral, MD, MHS Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03045276     History of Changes
Other Study ID Numbers: 16-013000
1R01DK110749 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not share individual participant data beyond those involved in the research study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Spina Bifida
Kidney Transplant
Additional relevant MeSH terms:
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Spinal Dysraphism
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Complement Factor H
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs