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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Seattle Children's Hospital | OTHER |
| Washington University School of Medicine |
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The broad aim of the proposed study is to improve medication adherence in adolescent kidney transplant recipients. The investigators hypothesize that a multi-component intervention will improve medication adherence in the adolescent kidney transplant population. The specific aims are to determine, in a randomized clinical trial, the efficacy of a structured, multi-component intervention in improving adherence to anti-rejection medications and graft outcomes, and to identify characteristics of healthcare systems that are independently associated with adherence.
Young kidney transplant recipients at 8 pediatric transplant centers in the United States and Canada will be invited to participate. Participants will be randomly assigned to either the control or intervention group. Adherence will be measured in all participants using an electronic medication monitoring multi-dose pillbox. Enrolment will be followed by a 3-month run-in period, during which group allocation will be concealed and no intervention administered. At the 3-month visit, participants assigned to the intervention group will form an Adherence Support Team including the participant, one or both parents, and a study facilitator who is not a member of the treating team. At the same visit the facilitator will provide standardized adherence education, and will initiate a novel 20-30 min. behavioural intervention, which combines problem-solving skills with implementation intentions (concrete action plans in which an individual specifies, in an if-then contingency format, when, where and how he or she will perform a behaviour, with the goal of developing habits). This intervention will focus on addressing adherence barriers identified using the validated Medication Barriers Survey 3 and selected by the participant as important to him or her. Subsequent study visits, at 3-month intervals, will include a briefer versions of the educational component, and review and updating of implementation intentions. In addition, the electronic pillbox will be configured to provide alarm, phone, or text message dose reminders to participants in the intervention group throughout the intervention interval. Control participants will also meet with the facilitator at 3-month intervals, but will simply discuss general health and life issues; they will not receive dose reminders. In between visits, the facilitator will maintain monthly contact with all participants via short phone or text-message check-ins to troubleshoot issues with the electronic pillbox. The primary outcome will be 'taking adherence' - the proportion of prescribed doses that were consumed. Appropriate timing of doses will also be evaluated, as will variability in medication levels (reflecting consistency of medication consumption), and graft outcomes. Level of adherence, patterns of change in adherence, and graft outcomes will be compared between intervention and control groups. Secondary observational analyses of collected study data will identify healthcare systems factors independently associated with adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-component Intervention | Experimental | Multi-component Intervention consisting of:
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| Attention control | No Intervention | Control group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Action-focused problem-solving | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Taking Adherence | Daily "taking adherence", defined as the percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given. To summarize adherence for each arm, we calculated the total percentage of days of observation for which there was 100% taking adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which taking adherence was 100%, summed across all participants. | 12 months |
| Timing Adherence | Daily "timing adherence", defined as the percentage of doses taken within 1 hour before to 2 hours after the prescribed dosing time each day (as measured by electronic monitoring). The daily timing adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a timing adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given. To summarize timing adherence for each arm, we calculated the total percentage of days of observation for which there was 100% timing adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which timing adherence was 100%, summed across all participants. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Deviation (SD) of Tacrolimus Trough Levels | The SD of all tacrolimus trough levels done for clinical care (except during hospitalizations or illnesses) were calculated for participants with >=3 tacrolimus levels. | 12 months |
| Self-reported Taking Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bethany J Foster, MD, MSCE | Montreal Children's Hospital of the MUHC | Principal Investigator |
| Susan L Furth, MD, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63130 | United States | ||
| Cincinnati Children's Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25176317 | Background | Foster BJ, Pai A, Zhao H, Furth S; TAKE-IT Study Group. The TAKE-IT study: aims, design, and methods. BMC Nephrol. 2014 Aug 30;15:139. doi: 10.1186/1471-2369-15-139. | |
| 36094829 | Derived | Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2. |
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1 patient withdrew after completing the enrollment visit, but before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Intervention | Participants in the intervention group will form an Adherence Support Team (AST), receive standardized adherence education, and complete behavioral intervention at 3-month intervals. In between visits, the study facilitator will maintain monthly contact with participants via short phone or text-message check-ins. The electronic pillbox will collect adherence data and will be configured to provide visual cue or text message dose reminders to participants in the intervention group. Participants in the intervention group will be fed back their electronic adherence data at each study visit. Action-focused problem-solving: An Adherence Support Team (AST), consisting of the patient, one or both parents (or primary caregiver), and the study facilitator, will be formed for each participant in the intervention arm. "Action-focused problem-solving" is informed by two complementary behavioral approaches: problem-solving and implementation intentions. Implementation intentions are concrete |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-in |
|
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| OTHER |
| British Columbia Children's Hospital | OTHER |
| The Hospital for Sick Children | OTHER |
| St. Justine's Hospital | OTHER |
| Temple University | OTHER |
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|
| Electronic pillbox monitoring, dose reminders, and feedback | Device |
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Self-reported taking adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention. |
| 12 months |
| Self-reported Timing Adherence | Self-reported timing adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken up to 2 hours after the prescribed time in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention. | 12 months |
| Acute Rejection Rate | The acute rejection rate, measured as rejections per 100 person-years of observation. | 12 months |
| Annualized Change in Estimated Glomerular Filtration Rate (eGFR) | Change in estimated glomerular filtration rate, estimated using the Schwartz equation for those < 18 y. and the CKD-EPI equation for those 18y and older, standardized to a 12-month period. | 12 months |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| University of Toronto Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Montreal Children's Hospital | Montreal | Quebec | H3G 1AF | Canada |
| St. Justine's Hospital | Montreal | Quebec | Canada |
| 31507087 | Derived | Boucquemont J, Pai ALH, Dharnidharka VR, Hebert D, Zelikovsky N, Amaral S, Furth SL, Foster BJ. Association between day of the week and medication adherence among adolescent and young adult kidney transplant recipients. Am J Transplant. 2020 Jan;20(1):274-281. doi: 10.1111/ajt.15590. Epub 2019 Oct 12. |
| 29994983 | Derived | Boucquemont J, Pai ALH, Dharnidharka VR, Hebert D, Furth SL, Foster BJ. Gender Differences in Medication Adherence Among Adolescent and Young Adult Kidney Transplant Recipients. Transplantation. 2019 Apr;103(4):798-806. doi: 10.1097/TP.0000000000002359. |
| 29602631 | Derived | Foster BJ, Pai ALH, Zelikovsky N, Amaral S, Bell L, Dharnidharka VR, Hebert D, Holly C, Knauper B, Matsell D, Phan V, Rogers R, Smith JM, Zhao H, Furth SL. A Randomized Trial of a Multicomponent Intervention to Promote Medication Adherence: The Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial (TAKE-IT). Am J Kidney Dis. 2018 Jul;72(1):30-41. doi: 10.1053/j.ajkd.2017.12.012. Epub 2018 Mar 27. |
| FG001 | Attention Control | Control participants will receive an electronic pillbox to measure medication adherence. They will meet with the study facilitator at 3-month intervals to discuss general health and life issues. The dose reminder functions of the electronic pillbox will not be enabled. |
| COMPLETED | run-in |
|
| NOT COMPLETED |
|
| Intervention Interval |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Intervention | Participants in the intervention group form an Adherence Support Team (AST), receive standardized adherence education, and complete behavioral intervention at 3-month intervals. In between visits, the study facilitator will maintain monthly contact with participants via short phone or text-message check-ins. The electronic pillbox will collect adherence data and will be configured to provide visual cue or text message dose reminders to participants in the intervention group. Participants in the intervention group will be fed back their electronic adherence data at each study visit. Action-focused problem-solving: An Adherence Support Team (AST), consisting of the patient, one or both parents (or primary caregiver), and the study facilitator, will be formed for each participant in the intervention arm. "Action-focused problem-solving" is informed by two complementary behavioral approaches: problem-solving and implementation intentions. Implementation intentions are concrete |
| BG001 | Attention Control | Control participants will receive an electronic pillbox to measure medication adherence. They will meet with the study facilitator at 3-month intervals to discuss general health and life issues. The dose reminder functions of the electronic pillbox will not be enabled. |
| BG002 | 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 | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| medication insurer | Count of Participants | Participants |
| ||||||||||||||||
| household income | Count of Participants | Participants |
| ||||||||||||||||
| median years post-transplant | Median | Inter-Quartile Range | years |
| |||||||||||||||
| donor source | Count of Participants | Participants |
| ||||||||||||||||
| median total lifetime duration of dialysis | Median | Inter-Quartile Range | Months |
| |||||||||||||||
| primary disease | Count of Participants | Participants |
| ||||||||||||||||
| number of past acute rejections | Count of Participants | Participants |
| ||||||||||||||||
| number of comorbidities | Count of Participants | Participants |
| ||||||||||||||||
| number of doses of immunosuppressives per day | Median | Inter-Quartile Range | number of doses per day |
| |||||||||||||||
| pre-intervention taking adherence | Number | % days with 100% taking adherence |
| ||||||||||||||||
| Total Adolescent Medication Barriers scale score | A higher Adolescent medication Barriers Scale (AMBS) represents a greater burden of barriers. The possible range for total score is 17-85. | Mean | Standard Deviation | units on a scale |
|
| 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 | Taking Adherence | Daily "taking adherence", defined as the percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given. To summarize adherence for each arm, we calculated the total percentage of days of observation for which there was 100% taking adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which taking adherence was 100%, summed across all participants. | We used unadjusted ordinal logistic regression with generalized estimating equations to account for repeated measures (i.e. score on each day) to compare taking and timing adherence between the intervention and control groups during the intervention interval. An additional 'as-treated' analysis was also conducted. All available data were included. | Posted | Number | % of days with 100% taking adherence | 12 months |
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| Primary | Timing Adherence | Daily "timing adherence", defined as the percentage of doses taken within 1 hour before to 2 hours after the prescribed dosing time each day (as measured by electronic monitoring). The daily timing adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a timing adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given. To summarize timing adherence for each arm, we calculated the total percentage of days of observation for which there was 100% timing adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which timing adherence was 100%, summed across all participants. | We used unadjusted ordinal logistic regression with generalized estimating equations to account for repeated measures (i.e. score on each day) to compare timing adherence between the intervention and control groups during the intervention interval. An additional 'as-treated' analysis was also conducted. All available data were included. | Posted | Number | % of days with 100% timing adherence | 12 months |
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| Secondary | Standard Deviation (SD) of Tacrolimus Trough Levels | The SD of all tacrolimus trough levels done for clinical care (except during hospitalizations or illnesses) were calculated for participants with >=3 tacrolimus levels. | Posted | Median | Inter-Quartile Range | standard deviation units | 12 months |
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| Secondary | Self-reported Taking Adherence | Self-reported taking adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention. | included all those who participated during the intervention interval | Posted | Mean | Standard Deviation | percentage of prescribed doses taken | 12 months |
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| Secondary | Self-reported Timing Adherence | Self-reported timing adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken up to 2 hours after the prescribed time in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention. | included all those who participated during the intervention interval | Posted | Mean | Standard Deviation | percentage of doses taken on time | 12 months |
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| Secondary | Acute Rejection Rate | The acute rejection rate, measured as rejections per 100 person-years of observation. | included all those who participated during the intervention interval | Posted | Number | events per 100 person-years | 12 months |
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| Secondary | Annualized Change in Estimated Glomerular Filtration Rate (eGFR) | Change in estimated glomerular filtration rate, estimated using the Schwartz equation for those < 18 y. and the CKD-EPI equation for those 18y and older, standardized to a 12-month period. | included all those with eGFR data available | Posted | Median | Inter-Quartile Range | ml/min/1.73m^2 | 12 months |
|
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12 months
The standard definitions were used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multi-component Intervention |
| 0 | 76 | 24 | 76 | 42 | 76 |
| EG001 | Attention Control |
| 0 | 88 | 30 | 88 | 52 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalizations | General disorders | Non-systematic Assessment |
| ||
| PTLD | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute rejection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| CMV infection | Infections and infestations | Non-systematic Assessment |
| ||
| influenza infection | Infections and infestations | Non-systematic Assessment |
| ||
| other infection | Infections and infestations | Non-systematic Assessment |
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| vomiting/diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| surgery/procedure | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Abdominal pain | General disorders | Non-systematic Assessment |
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Patients who withdrew or ceased to use the pillbox may introduce bias if they represented patients who were more or less adherent than those who continued to use the pillbox.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bethany Foster | McGill University Health Centre | 514-412-4461 | bethany.foster@mcgill.ca |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| Asian |
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| Other |
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| United States |
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| Private |
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| Canada provincial |
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| $25,000- $50,000 |
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| $51,000- $75,000 |
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| $76,000- $100,000 |
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| >$100,000 |
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| prefer not to answer |
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| unknown |
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| Deceased |
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| glomerulonephritis |
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| Focal segmental glomerulosclerosis |
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| other |
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| 1 |
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| 2 or more |
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| at least 1 |
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| Superiority |
| OG001 | Attention Control | Control group study visits were conducted at the same intervals as intervention visits and consisted of the Coach engaging in active listening and providing non-specific support only. Adherence was NOT discussed with control participants. |
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