Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial

Kidney Transplant Clinical Trial

— U-REAACT  

Official title:

Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045276
• Other study ID #: 16-013000
• Secondary ID: 1R01DK110749
• Status: Completed
• Phase: N/A
• Start date: June 29, 2017
• Est. completion date: April 9, 2022

Study information

• Verified date: October 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: April 9, 2022
• Est. primary completion date: April 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant
• Spina Bifida
• Spinal Dysraphism

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Ann & Robert H Lurie Children's Hospital of Chicago, Boston Children's Hospital, Children's Healthcare of Atlanta, Children's Mercy Hospital Kansas City, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Executive Function	Behavior Rating Inventory of Executive Function questionnaire will be administered and answers will be analyzed.	12.5 months
Other	Perceived Treatment Barriers - Spina Bifida	The Spina Bifida and Cathing Barriers measure will be administered and answers will be analyzed.	12.5 months
Other	Mean Change in Perceived Adherence Behaviors as Measured by the Adolescent Medication Barriers Scale From Baseline to Intervention Period (6 Months)	The Adolescent Medication Barrier Scale will be administered to the kidney transplant patients and answers will be analyzed. The Adolescent Medication Barriers Scale (AMBS) endorsement score is the sum of 17 items (rated 1,2,3=0, rated 4 & 5=1). The higher the endorsement score (range of 0-17) indicates that the adolescent perceived themselves as having more barriers to medication adherence.	Baseline to 6 months
Other	Change in Self-Efficacy Score From Baseline to Intervention Period (6 Month)	Self-Efficacy for Managing Chronic Disease 6-Item Scale ranging from 1 (not at all confident) to 10 (totally confident). Total score is the mean of the 6-tems. The higher the score, the more self-efficacy. The outcome measure is the change in score 6 months-baseline.	baseline to 6 months
Other	Treatment Responsibility	Allocation of Treatment Responsibility and the Sharing of Spina Bifida Management Responsibilities surveys will be administered and answers will be analyzed.	12.5 months
Other	Change in Disease Knowledge Score From Baseline to Intervention (6 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. There are 20 questions, each correct question = 1, each incorrect question =0. The total score ranges from 0-20. The higher the score, the more knowledge the participant has. The outcome measure will measure the change in score from 6 months to baseline.	baseline to 6 months
Primary	Mean Percentage of Subjects With Adherence Behavior Greater Than or Equal to 85% From Baseline and Intervention Period (6-month)	Participants who do not submit the correct number of pictures within the prescribed window of their expected time due for treatment will be counted as non-adherent for that episode of med taking/cathing. The mean percentage of participants who achieved 85% adherence was calculated for each week from baseline (week 1) to the end of the 6 month time point (week 26).	baseline to 6 months
Primary	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.	12.5 months
Secondary	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.	12.5 months
Secondary	Change in Coefficient of Variation (CV) of Immunosuppressive Drug Levels (Tacrolimus or Sirolimus) Between the Baseline (run-in) and Intervention Period.	The difference between the coefficient of variation (CV) of immunosuppressive drug levels in kidney transplant patients at baseline and intervention period (6 months). CV was calculated using the average of three values of immunosuppressive drug levels at each time point. The change was calculated as the difference in mean value between baseline and 6 months.	baseline and at 6 months