Trial Outcomes & Findings for Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial (NCT NCT03045276)

Last Updated: 2023-11-09

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

465 participants

Primary outcome timeframe

baseline to 6 months

Results posted on

2023-11-09

Participant Flow

The recruitment period was from June 2017-April 2021. Potential participants were recruited from nephrology, urology, and Spina Bifida outpatient clinics either in person or over the phone.

After consenting to be a part of the study, participants were required to complete a set of baseline questionnaires before being assigned to a study arm. If a participant did not complete the questionnaires, they were not allowed to continue.

Participant milestones

Participant milestones
Measure	KT 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 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). In Arm 1, participants will not receive personalized feedback, nor will they receive the "extra" incentive of $10 for meeting their adherence goal.	KT 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 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). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.	SB 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 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 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.	SB 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 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 spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.
Intervention Phase STARTED	77	78	52	51
Intervention Phase COMPLETED	67	73	49	44
Intervention Phase NOT COMPLETED	10	5	3	7
Follow-Up Phase STARTED	67	73	49	44
Follow-Up Phase COMPLETED	66	68	45	39
Follow-Up Phase NOT COMPLETED	1	5	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	KT 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 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). In Arm 1, participants will not receive personalized feedback, nor will they receive the "extra" incentive of $10 for meeting their adherence goal.	KT 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 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). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.	SB 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 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 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.	SB 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 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 spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.
Intervention Phase Withdrawal by Subject	7	2	3	7
Intervention Phase Developed exclusionary criteria	3	3	0	0
Follow-Up Phase Withdrawal by Subject	0	4	4	4
Follow-Up Phase Lost to Follow-up	0	1	0	1
Follow-Up Phase Developed exclusionary criteria	1	0	0	0

Baseline Characteristics

Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KT Arm 1 - No Feedback, Minimum Incentive n=77 Participants 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 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). In Arm 1, participants will not receive personalized feedback, nor will they receive the "extra" incentive of $10 for meeting their adherence goal.	KT Arm 2 - Feedback, Maximum Incentive n=78 Participants 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 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). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.	SB Arm 1- No Feedback, Minimum Incentive n=52 Participants 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 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 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.	SB Arm 2- Feedback, Maximum Incentive n=51 Participants 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 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 spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.	Total n=258 Participants Total of all reporting groups
Age, Continuous	16.7 years STANDARD_DEVIATION 2.9 • n=5 Participants	16.8 years STANDARD_DEVIATION 2.7 • n=7 Participants	17.3 years STANDARD_DEVIATION 2.9 • n=5 Participants	16.7 years STANDARD_DEVIATION 3.4 • n=4 Participants	16.8 years STANDARD_DEVIATION 3.1 • n=21 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	40 Participants n=7 Participants	33 Participants n=5 Participants	26 Participants n=4 Participants	131 Participants n=21 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	38 Participants n=7 Participants	19 Participants n=5 Participants	25 Participants n=4 Participants	127 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	31 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	70 Participants n=7 Participants	45 Participants n=5 Participants	46 Participants n=4 Participants	227 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	14 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	44 Participants n=21 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	57 Participants n=7 Participants	28 Participants n=5 Participants	38 Participants n=4 Participants	169 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	4 Participants n=4 Participants	28 Participants n=21 Participants
Region of Enrollment United States	77 participants n=5 Participants	78 participants n=7 Participants	52 participants n=5 Participants	51 participants n=4 Participants	258 participants n=21 Participants

PRIMARY outcome

Timeframe: baseline to 6 months

Population: These analyses followed the intention to treat principle.

Outcome measures

Outcome measures
Measure	KT Arm 1 - No Feedback, Minimum Incentive n=77 Participants 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 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). In Arm 1, participants will not receive personalized feedback, nor will they receive the "extra" incentive of $10 for meeting their adherence goal.	KT Arm 2 - Feedback, Maximum Incentive n=78 Participants 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 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). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.	SB Arm 1- No Feedback, Minimum Incentive n=52 Participants 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 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 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.	SB Arm 2- Feedback, Maximum Incentive n=51 Participants 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 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 spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.
Mean Percentage of Subjects With Adherence Behavior Greater Than or Equal to 85% From Baseline and Intervention Period (6-month)	30.56 percentage of subjects Standard Deviation 0.08	42.04 percentage of subjects Standard Deviation 0.05	6.39 percentage of subjects Standard Deviation 0.03	12.14 percentage of subjects Standard Deviation 0.02

PRIMARY outcome

Timeframe: 12.5 months

Population: No data were collected on how often the participants used the portal. Only data on how often they utilized the text messaging portion of the program was collected and these were analyzed as part of adherence (primary outcome measure 1).

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12.5 months

Population: This secondary outcome could not be analyzed because urodynamic studies were very inconsistently performed on our subjects at each site. In order to calculate change in pressure per unit volume of the bladder, at least two urodynamic studies much be performed per patient. There were no patients who had two urodynamic studies performed so change could not be calculated and this outcome could not be analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and at 6 months

Population: In order to calculate the coefficient of variation of immunosuppressive drug levels, three values are needed at each time point. Those that did not have three values at either time point could not be analyzed. Therefore the number of participants analyzed is less than the number randomized to each group.

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.

Outcome measures

Outcome measures
Measure	KT Arm 1 - No Feedback, Minimum Incentive n=40 Participants 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 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). In Arm 1, participants will not receive personalized feedback, nor will they receive the "extra" incentive of $10 for meeting their adherence goal.	KT Arm 2 - Feedback, Maximum Incentive n=42 Participants 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 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). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.	SB 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 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 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.	SB 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 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 spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.
Change in Coefficient of Variation (CV) of Immunosuppressive Drug Levels (Tacrolimus or Sirolimus) Between the Baseline (run-in) and Intervention Period.	4.69 change in coefficient of variation Standard Deviation 23.68	0.25 change in coefficient of variation Standard Deviation 23.19	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12.5 months

Behavior Rating Inventory of Executive Function questionnaire will be administered and answers will be analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12.5 months

The Spina Bifida and Cathing Barriers measure will be administered and answers will be analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: In order to calculate change between baseline and 6 months, KT participants needed to complete the AMBS measure at both timepoints. If the survey was missing at 6 months, they were not included in the analyses which is why the participants analyzed does not match the randomized number. This scale was only applicable to the KT cohort since we were measuring cathing adherence with the SB cohort and not medication adherence.

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.

Outcome measures

Outcome measures
Measure	KT Arm 1 - No Feedback, Minimum Incentive n=45 Participants 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 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). In Arm 1, participants will not receive personalized feedback, nor will they receive the "extra" incentive of $10 for meeting their adherence goal.	KT Arm 2 - Feedback, Maximum Incentive n=45 Participants 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 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). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.	SB 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 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 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.	SB 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 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 spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.
Mean Change in Perceived Adherence Behaviors as Measured by the Adolescent Medication Barriers Scale From Baseline to Intervention Period (6 Months)	0.40 score on a scale Standard Deviation 2.32	0.27 score on a scale Standard Deviation 2.21	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

Population: In order to calculate change, the Self-efficacy for Managing Chronic Disease questionnaire needed to be answered at both the baseline and 6 month time points. If missing at either timepoint, they were excluded from the analyses.

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.

Outcome measures

Outcome measures
Measure	KT Arm 1 - No Feedback, Minimum Incentive n=45 Participants 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 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). In Arm 1, participants will not receive personalized feedback, nor will they receive the "extra" incentive of $10 for meeting their adherence goal.	KT Arm 2 - Feedback, Maximum Incentive n=44 Participants 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 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). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.	SB Arm 1- No Feedback, Minimum Incentive n=34 Participants 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 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 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.	SB Arm 2- Feedback, Maximum Incentive n=16 Participants 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 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 spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.
Change in Self-Efficacy Score From Baseline to Intervention Period (6 Month)	-0.38 score on a scale Standard Deviation 1.92	0.23 score on a scale Standard Deviation 2.12	0.1 score on a scale Standard Deviation 1.59	-0.8 score on a scale Standard Deviation 1.77

OTHER_PRE_SPECIFIED outcome

Timeframe: 12.5 months

Allocation of Treatment Responsibility and the Sharing of Spina Bifida Management Responsibilities surveys will be administered and answers will be analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 6 months

Population: The change in knowledge score can only be calculated if the participant completes the questionnaire at both the baseline and 6 month timepoints. If it is missing at either timepoint, they were not included in the analyses.

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.

Outcome measures

Outcome measures
Measure	KT Arm 1 - No Feedback, Minimum Incentive n=45 Participants 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 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). In Arm 1, participants will not receive personalized feedback, nor will they receive the "extra" incentive of $10 for meeting their adherence goal.	KT Arm 2 - Feedback, Maximum Incentive n=45 Participants 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 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). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.	SB Arm 1- No Feedback, Minimum Incentive n=39 Participants 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 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 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.	SB Arm 2- Feedback, Maximum Incentive n=29 Participants 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 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 spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal.
Change in Disease Knowledge Score From Baseline to Intervention (6 Months)	-0.29 score on a scale Standard Deviation 2.71	0 score on a scale Standard Deviation 2.79	0.92 score on a scale Standard Deviation 4.84	1.1 score on a scale Standard Deviation 5.14

Adverse Events

Arm 1 - No Feedback, Minimum Incentive

Serious events: 32 serious events

Other events: 32 other events

Deaths: 0 deaths

Arm 2 - Feedback, Maximum Incentive

Serious events: 34 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm 1 - No Feedback, Minimum Incentive n=129 participants at risk 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 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.	Arm 2 - Feedback, Maximum Incentive n=129 participants at risk 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 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.
General disorders Acute Illness	10.1% 13/129 • Number of events 16 • Adverse events were collected during the duration of a subject's participation in the study, which was one year. There is no greater than minimal risk to subjects in this study. Any AE associated with the study protocol would be immediately reported to the DSMB, the PIs and the IRB. If the AE was not considered related to the study protocol, it did not need to be reported. We confirm there were no participant deaths that occurred during the course of the study. All SAEs and AEs reported here were collected as hospitalizations that occurred during the study and none were considered related to the study.	9.3% 12/129 • Number of events 14 • Adverse events were collected during the duration of a subject's participation in the study, which was one year. There is no greater than minimal risk to subjects in this study. Any AE associated with the study protocol would be immediately reported to the DSMB, the PIs and the IRB. If the AE was not considered related to the study protocol, it did not need to be reported. We confirm there were no participant deaths that occurred during the course of the study. All SAEs and AEs reported here were collected as hospitalizations that occurred during the study and none were considered related to the study.
Renal and urinary disorders Concern for rejection	9.3% 12/129 • Number of events 21 • Adverse events were collected during the duration of a subject's participation in the study, which was one year. There is no greater than minimal risk to subjects in this study. Any AE associated with the study protocol would be immediately reported to the DSMB, the PIs and the IRB. If the AE was not considered related to the study protocol, it did not need to be reported. We confirm there were no participant deaths that occurred during the course of the study. All SAEs and AEs reported here were collected as hospitalizations that occurred during the study and none were considered related to the study.	10.9% 14/129 • Number of events 26 • Adverse events were collected during the duration of a subject's participation in the study, which was one year. There is no greater than minimal risk to subjects in this study. Any AE associated with the study protocol would be immediately reported to the DSMB, the PIs and the IRB. If the AE was not considered related to the study protocol, it did not need to be reported. We confirm there were no participant deaths that occurred during the course of the study. All SAEs and AEs reported here were collected as hospitalizations that occurred during the study and none were considered related to the study.
Renal and urinary disorders Urinary Tract Infection Related	5.4% 7/129 • Number of events 12 • Adverse events were collected during the duration of a subject's participation in the study, which was one year. There is no greater than minimal risk to subjects in this study. Any AE associated with the study protocol would be immediately reported to the DSMB, the PIs and the IRB. If the AE was not considered related to the study protocol, it did not need to be reported. We confirm there were no participant deaths that occurred during the course of the study. All SAEs and AEs reported here were collected as hospitalizations that occurred during the study and none were considered related to the study.	9.3% 12/129 • Number of events 14 • Adverse events were collected during the duration of a subject's participation in the study, which was one year. There is no greater than minimal risk to subjects in this study. Any AE associated with the study protocol would be immediately reported to the DSMB, the PIs and the IRB. If the AE was not considered related to the study protocol, it did not need to be reported. We confirm there were no participant deaths that occurred during the course of the study. All SAEs and AEs reported here were collected as hospitalizations that occurred during the study and none were considered related to the study.

Additional Information

Dr. Sandra Amaral

Children's Hospital of Philadelphia

Phone: 2678443097

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place