Spina BifidaU-REAACTNCT03045276

Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial

A study testing Behavioral Feedback and Economic Incentives: Arm 1 and Behavioral Feedback and Economic Incentives: Arm 2 in people with Spina Bifida and Kidney Transplant, run by Children's Hospital of Philadelphia at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 12 to 24 years
Conditions the study is for: Spina Bifida, Kidney Transplant
What is being tested?: Behavioral Feedback and Economic Incentives: Arm 1 and Behavioral Feedback and Economic Incentives: Arm 2
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 465 participants
Where: 6 sitesUnited States
Study dates: 29 Jun 2017to 9 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 24 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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

Show all 10Show fewer

Less than 3 months post-transplant.
Unable to perform CIC.
Prescribed Immunosuppressive medications once per day.
Provider recommendations of CIC once per day

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Boston Children's Hospital
Boston, Massachusetts, 02115
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Children's Mercy Hospital
Kansas City, Missouri, 64108
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Children's Hospital
Seattle, Washington, 98105

Other trials in United States

About this study

Read the 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.

Conditions: Spina Bifida, Kidney Transplant
Being tested: Behavioral Feedback and Economic Incentives: Arm 1, Behavioral Feedback and Economic Incentives: Arm 2
Keywords: Spina Bifida, Kidney Transplant
Medical subject headings: Spinal Dysraphism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral Feedback and Economic Incentives: Arm 1Behavioural
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 2Behavioural
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.

Study groups in NCT03045276
Study group	Role	What they receive
Arm 1 - No Feedback, Minimum Incentive	Active comparator	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. Receives: Behavioral: Behavioral Feedback and Economic Incentives: Arm 1
Arm 2 - Feedback, Maximum Incentive	Active comparator	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. Receives: Behavioral: Behavioral Feedback and Economic Incentives: Arm 2

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: baseline to 6 months
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.
Measured: 12.5 months

Secondary outcomes (2)

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.
Measured: 12.5 months
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.
Measured: baseline and at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 20179 Apr 2022

First posted7 Feb 2017 (estimated)
Study start29 Jun 2017
Primary completion9 Apr 2022
Study completion9 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spina BifidaStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 465 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03045276
Sponsor's protocol ID: 16-013000
Other IDs: 1R01DK110749
Acronym: U-REAACT
Status last verified: Oct 2023
First submitted: 31 Jan 2017
Last updated: 9 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We will not share individual participant data beyond those involved in the research study.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial
ClinicalTrials.gov ID: NCT03045276
Acronym / sponsor ID: U-REAACT / 16-013000
Conditions: Spina Bifida, Kidney Transplant
Keywords: Spina Bifida, Kidney Transplant
Study type: Interventional
Recruitment status: Completed
Enrolment: 465 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
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
Study start: 29 Jun 2017 (actual)
Primary completion: 9 Apr 2022 (actual)
Study completion: 9 Apr 2022 (actual)
First posted: 7 Feb 2017 (estimated)
Results: Posted 9 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Arm 1 - No Feedback, Minimum Incentive	Active comparator	Behavioral: Behavioral Feedback and Economic Incentives: Arm 1Subjects 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 2 - Feedback, Maximum Incentive	Active comparator	Behavioral: Behavioral Feedback and Economic Incentives: Arm 2Subjects 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.

Who may qualify

Ages: 12 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Behavioral Feedback and Economic Incentives: Arm 1The 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.	Behavioural	Arm 1 - No Feedback, Minimum Incentive
Behavioral Feedback and Economic Incentives: Arm 2The 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.	Behavioural	Arm 2 - Feedback, Maximum Incentive

Primary outcome

Mean Percentage of Subjects With Adherence Behavior Greater Than or Equal to 85% From Baseline and Intervention Period (6-month)
Time frame: baseline to 6 months
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).
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.

2 secondary outcomes

Change in Pressure Per Unit Volume of Bladder of Spina Bifida Subjects
Time frame: 12.5 months
Change in Coefficient of Variation (CV) of Immunosuppressive Drug Levels (Tacrolimus or Sirolimus) Between the Baseline (run-in) and Intervention Period.
Time frame: baseline and at 6 months

Results and safety

Results posted to the registry on 9 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KT Arm 1 - No Feedback, Minimum Incentive	77	67
KT Arm 2 - Feedback, Maximum Incentive	78	73
SB Arm 1- No Feedback, Minimum Incentive	52	49
SB Arm 2- Feedback, Maximum Incentive	51	44

Primary outcome: Mean Percentage of Subjects With Adherence Behavior Greater Than or Equal to 85% From Baseline and Intervention Period (6-month)

Time frame: baseline to 6 months. Mean (Standard Deviation). Unit: percentage of subjects

Measure	KT Arm 1 - No Feedback, Minimum Incentive n = 77	KT Arm 2 - Feedback, Maximum Incentive n = 78	SB Arm 1- No Feedback, Minimum Incentive n = 52	SB Arm 2- Feedback, Maximum Incentive n = 51
Value	30.56 (0.08)	42.04 (0.05)	6.39 (0.03)	12.14 (0.02)

Population analysed: These analyses followed the intention to treat principle.

Primary outcome: Study Efficacy of Use of Way to Health Portal System

Time frame: 12.5 months

Population analysed: 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).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the duration of a subject's participation in the study, which was one year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 - No Feedback, Minimum Incentive	32 of 129 (24.8%)	32 of 129 (24.8%)	0 of 129
Arm 2 - Feedback, Maximum Incentive	34 of 129 (26.4%)	38 of 129 (29.5%)	0 of 129

Limitations and caveats (from the sponsor): Due to issues with recruitment, our final sample size is likely underpowered. Low response rates for some of our study surveys also prevented us from having enough data to analyze some of our secondary outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. We will not share individual participant data beyond those involved in the research study.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandra Amaral, MD, MHS principal investigator

Children's Hospital of Philadelphia

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percentage of Subjects With Adherence Behavior Greater Than or Equal to 85% From Baseline and Intervention Period (6-month) (time frame: baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03045276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.