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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK110749 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Boston Children's Hospital | OTHER |
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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).
The overarching goal of this five-year, phase II, randomized clinical trial is to improve poor long-term health outcomes in both adolescents and young adults (AYA) with either a kidney transplant (KT) or spina bifida (SB), respectively. More specifically, this study will focus on decreasing premature allograft loss in subjects with kidney transplant (KT) due to medication nonadherence and kidney damage in subjects with SB due to urinary non-continence. To achieve these goals, this study will implement a real-time feedback system, Way to Health (WTH), that will provide education and support, increase awareness and incentivize positive health behavior, in addition to standard of care. Further, this study will investigate the mechanisms of behavior change by examining the role of financial incentives, positive feedback and the relationship between the two. The study will compare two cohorts of KT and SB subjects, which will undergo varied levels of financial incentives and positive feedback. Data from KT and SB subjects will be analyzed jointly and separately. This innovative mobile health (mhealth) strategy will improve our current measures of adherence and increase our understanding of factors that influence adherence for two AYA populations, KT and SB subjects, respectively. The study will contribute novel insight to inform the design of future interventions targeting persistence of behavior change and can be used in other centers and for other chronic disease groups.
The study intervention will use the WTH web-based platform to support AYA with KT or SB as they navigate their daily treatment burdens. This will be achieved via bi-directional text messaging, including the sending of reminders and positive feedback by WTH and the messaging of pictures of medication or catheter in hand at time of treatment by the participant. This intervention will assess sustainability of this novel bi-directional messaging system and the impact of providing education and support, increasing awareness and incentivizing positive health behavior in real-time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Feedback and Economic Incentives: Arm 1 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Coefficient of Variation (CV) of Immunosuppressive Drug Levels (Tacrolimus or Sirolimus) Between the Baseline (run-in) and Intervention Period. |
| Measure | Description | Time Frame |
|---|---|---|
| Executive Function | Behavior Rating Inventory of Executive Function questionnaire will be administered and answers will be analyzed. | 12.5 months |
| Perceived Treatment Barriers - Spina Bifida | The Spina Bifida and Cathing Barriers measure will be administered and answers will be analyzed. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Amaral, MD, MHS | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States | ||
| Ann & Robert H. Lurie Children's Hospital of Chicago |
We will not share individual participant data beyond those involved in the research study.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Intervention Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2020 |
Not provided
| Children's Healthcare of Atlanta |
| OTHER |
| Children's Mercy Hospital Kansas City | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Seattle Children's Hospital | OTHER |
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|
| Behavioral Feedback and Economic Incentives: Arm 2 | Behavioral | 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. |
|
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 |
| 12.5 months |
| 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 |
| 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 |
| 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 |
| 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 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-Up Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | These analyses followed the intention to treat principle. | Posted | Mean | Standard Deviation | percentage of subjects | 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. | 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). | Posted | 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. | 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. | Posted | 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. | 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. | Posted | Mean | Standard Deviation | change in coefficient of variation | baseline and at 6 months |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Executive Function | Behavior Rating Inventory of Executive Function questionnaire will be administered and answers will be analyzed. | Not Posted | 12.5 months | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Perceived Treatment Barriers - Spina Bifida | The Spina Bifida and Cathing Barriers measure will be administered and answers will be analyzed. | Not Posted | 12.5 months | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 months |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline to 6 months |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Treatment Responsibility | Allocation of Treatment Responsibility and the Sharing of Spina Bifida Management Responsibilities surveys will be administered and answers will be analyzed. | Not Posted | 12.5 months | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline to 6 months |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) 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. | 0 | 129 | 32 | 129 | 32 | 129 |
| EG001 | 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) or spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal. | 0 | 129 | 34 | 129 | 38 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Bowel Dysfunction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Headaches | General disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Other Renal Related | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Paraesophageal Hiatal Hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Psychiatric | Psychiatric disorders | Non-systematic Assessment |
| ||
| Scoliosis | Nervous system disorders | Non-systematic Assessment |
| ||
| Shunt issue | Nervous system disorders | Non-systematic Assessment |
| ||
| Spinal | Nervous system disorders | Non-systematic Assessment |
| ||
| Surgery | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Syncope | General disorders | Non-systematic Assessment |
| ||
| Ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Upper Respiratory Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary Issue | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Illness | General disorders | Non-systematic Assessment | Can include fever, abdominal pain, vomitting, diarrhea) |
| |
| Concern for rejection | Renal and urinary disorders | Non-systematic Assessment | Can include acute rejection, elevated creatinine, IVIG infusion |
| |
| Urinary Tract Infection Related | Renal and urinary disorders | Non-systematic Assessment |
|
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.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sandra Amaral | Children's Hospital of Philadelphia | 2678443097 | amarals@chop.edu |
| Apr 5, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2021 | Nov 8, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016135 | Spinal Dysraphism |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| Lost to Follow-up |
|
| Developed exclusionary criteria |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| OG001 | 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) or spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an "extra" incentive of $10 for meeting their adherence goal. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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