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Intervention to Improve Adherence in Teen Kidney Transplant (TAKE-IT)

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ClinicalTrials.gov Identifier: NCT01356277
Recruitment Status : Completed
First Posted : May 19, 2011
Results First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
Seattle Children's Hospital
Washington University School of Medicine
British Columbia Children's Hospital
The Hospital for Sick Children
St. Justine's Hospital
Temple University
Information provided by (Responsible Party):
Beth Foster, McGill University Health Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Kidney Transplantation
Medication Adherence
Interventions: Behavioral: Action-focused problem-solving
Device: Electronic pillbox monitoring, dose reminders, and feedback

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 patient withdrew after completing the enrollment visit, but before randomization.

Reporting Groups
  Description
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

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.

Participant Flow for 2 periods

Period 1:   Run-in
    Behavioral Intervention   Attention Control
STARTED [1]   81   88 
COMPLETED [1]   76   88 
NOT COMPLETED   5   0 
[1] Run-in

Period 2:   Intervention Interval
    Behavioral Intervention   Attention Control
STARTED   76   88 
COMPLETED   66   81 
NOT COMPLETED   10   7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

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.
Total Total of all reporting groups

Baseline Measures
   Behavioral Intervention   Attention Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 81   88   169 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 15.5 
 (13.2 to 17.4) 
 15.8 
 (13.3 to 17.4) 
 15.8 
 (13.2 to 17.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      35  43.2%      34  38.6%      69  40.8% 
Male      46  56.8%      54  61.4%      100  59.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      9  11.1%      5   5.7%      14   8.3% 
Not Hispanic or Latino      72  88.9%      83  94.3%      155  91.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
White      57  70.4%      57  64.8%      114  67.5% 
Black      9  11.1%      11  12.5%      20  11.8% 
Asian      4   4.9%      7   8.0%      11   6.5% 
Other      11  13.6%      13  14.8%      24  14.2% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Canada   27   32   59 
United States   54   56   110 
medication insurer 
[Units: Participants]
Count of Participants
     
U.S. Public      26  32.1%      20  22.7%      46  27.2% 
Private      28  34.6%      36  40.9%      64  37.9% 
Canada provincial      27  33.3%      32  36.4%      59  34.9% 
household income 
[Units: Participants]
Count of Participants
     
< $25,000      19  23.5%      10  11.4%      29  17.2% 
$25,000- $50,000      17  21.0%      20  22.7%      37  21.9% 
$51,000- $75,000      17  21.0%      22  25.0%      39  23.1% 
$76,000- $100,000      6   7.4%      9  10.2%      15   8.9% 
>$100,000      12  14.8%      16  18.2%      28  16.6% 
prefer not to answer      5   6.2%      2   2.3%      7   4.1% 
unknown      5   6.2%      9  10.2%      14   8.3% 
median years post-transplant 
[Units: Years]
Median (Inter-Quartile Range)
 3.7 
 (0.7 to 7.9) 
 3.0 
 (0.8 to 7.2) 
 3.1 
 (0.7 to 7.5) 
donor source 
[Units: Participants]
Count of Participants
     
Living      37  45.7%      51  58.0%      88  52.1% 
Deceased      44  54.3%      37  42.0%      81  47.9% 
median total lifetime duration of dialysis 
[Units: Months]
Median (Inter-Quartile Range)
 10.0 
 (0.1 to 19.0) 
 5.0 
 (0 to 12.0) 
 6.0 
 (0.0 to 15.0) 
primary disease 
[Units: Participants]
Count of Participants
     
Congenital anomalies of the kidneys/ urinary tract      29  35.8%      41  46.6%      70  41.4% 
glomerulonephritis      9  11.1%      5   5.7%      14   8.3% 
Focal segmental glomerulosclerosis      14  17.3%      6   6.8%      20  11.8% 
other      29  35.8%      36  40.9%      65  38.5% 
number of past acute rejections 
[Units: Participants]
Count of Participants
     
    59  72.8%      76  86.4%      135  79.9% 
    16  19.8%      8   9.1%      24  14.2% 
2 or more      6   7.4%      4   4.5%      10   5.9% 
number of comorbidities 
[Units: Participants]
Count of Participants
     
    41  50.6%      43  48.9%      84  49.7% 
at least 1      40  49.4%      45  51.1%      85  50.3% 
number of doses of immunosuppressives per day 
[Units: Number of doses per day]
Median (Inter-Quartile Range)
 7 
 (5 to 9) 
 7 
 (5 to 9) 
 7 
 (5 to 9) 
pre-intervention taking adherence 
[Units: % days with 100% taking adherence]
 72.8   74.7   73.8 
Total Adolescent Medication Barriers scale score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 37.5  (11.2)   38.1  (9.8)   37.7  (10.5) 
[1] A higher Adolescent medication Barriers Scale (AMBS) represents a greater burden of barriers. The possible range for total score is 17-85.


  Outcome Measures

1.  Primary:   Taking Adherence   [ Time Frame: 12 months ]

2.  Primary:   Timing Adherence   [ Time Frame: 12 months ]

3.  Secondary:   Standard Deviation (SD) of Tacrolimus Trough Levels   [ Time Frame: 12 months ]

4.  Secondary:   Self-reported Taking Adherence   [ Time Frame: 12 months ]

5.  Secondary:   Self-reported Timing Adherence   [ Time Frame: 12 months ]

6.  Secondary:   Acute Rejection Rate   [ Time Frame: 12 months ]

7.  Secondary:   Annualized Change in Estimated Glomerular Filtration Rate (eGFR)   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Bethany Foster
Organization: McGill University Health Centre
phone: 514-412-4461
e-mail: bethany.foster@mcgill.ca


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Beth Foster, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01356277     History of Changes
Other Study ID Numbers: R01DK092977-01 ( U.S. NIH Grant/Contract )
First Submitted: May 17, 2011
First Posted: May 19, 2011
Results First Submitted: April 23, 2018
Results First Posted: July 18, 2018
Last Update Posted: July 18, 2018