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PLATO - Medication Adherence in Transplant Recipients

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ClinicalTrials.gov Identifier: NCT04078750
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
John Gill, University of British Columbia

Brief Summary:
Non-adherence with immunosuppressant drugs is a major reason for premature kidney transplant failure. Currently, patient education and compliance aids (e.g bubble packing) are commonly used to assist patients. This is a study involving patients expected to undergo a kidney transplant within 6 months. One group will undergo a one-month formal assessment of adherence before transplantation using mock immunosuppressant medication. Standardized surveys will also be administered to assess risk factors for non-adherence. A plan will be developed for use after the transplant. The other group will undergo usual care. Kidney function and rejection rates will be compared between two groups.

Condition or disease Intervention/treatment Phase
Kidney Disease, Chronic Medication Adherence Renal Disease Kidney Rejection Transplant Behavioral: Tailored medication adherence plan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pre-Transplant Multidisciplinary Assessment on Medication Adherence and Transplant Outcomes
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : September 30, 2022

Arm Intervention/treatment
Sham Comparator: Phase I. Control group
  1. The standard of care will be provided to the control group pre- and post-transplant. This does not involve any direct pre-transplant assessment of medication adherence or risk factors for non-adherence.
  2. Tacrolimus capsules will be dispensed in Medication Event Monitoring System (MEMS) caps for 3 months post-transplant for the purpose of measuring adherence after transplantation.
  3. Patients will be asked to complete Basel Assessment of Adherence to Immunosuppressive Medication instrument (BAASIS) questionnaire and Long-term Medication Behaviour Self-efficacy Scale at 3 months after transplantation.
Behavioral: Tailored medication adherence plan
Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps.

Experimental: Phase II. Intervention group
Patients will be given lactose containing white- and yellow-colored gelatin capsules stored in (MEMS®) bottles for a 1-month adherence trial. Yellow-colored gelatin capsules represent tacrolimus 0.5mg capsules while white-colored gelatin capsules represent tacrolimus 1mg capsules. MEMS® is designed to record the date/time of opening and closure of the drug vial. Patients will be asked to take a certain dose and expected to remove the correct number of white and yellow capsules from respective vial at the correct time each day. Phone calls will be made to patients to change the 'dose' at various times throughout the month to mimic the frequent need to make tacrolimus dosing changes early post-transplant.Pill count and MEMS record will be reviewed at the end of the 1-month trial period to assess adherence. Patients will also undergo health literacy, cognition testing, self-efficacy tests, with a customized post-transplant plan.
Behavioral: Tailored medication adherence plan
Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps.




Primary Outcome Measures :
  1. Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps. [ Time Frame: 3 month duration ]
    Adherence is defined as patient opening the MEMS caps within 1 hour of dosing times (ie no missed doses AND ≤ 1-hour variations to scheduled dosing times). Assumption will be made that patient has taken the correct tacrolimus dose if he or she opens MEMS caps within predefined dosing times. Using the MEMS recorded electronic dosing history, a daily binary adherence rate will be calculated per patient (ie day with correct dosing and/or timing). It is recognized that adherence rate may wane over time post-transplant. A 3-month duration is chosen for the primary outcome for logistical reasons since out-of-town patients are usually transferred back to a peripheral transplant center closer to home at this time. A pilot will be conducted for 40 local transplant recipients (20 each in control and interventional groups) to extend the use of MEMS for 6 months to capture any differences in adherence rates beyond three months.


Secondary Outcome Measures :
  1. Self-reported adherence rates as measured by BAASIS [ Time Frame: 3-12 months ]
    Patients will be asked by research assistant to complete BAASIS questionnaire at 3 months after transplant (may be a phone call if patients are transferred to peripheral centers before 3 months).

  2. The coefficient of variation (CV) of tacrolimus trough levels [ Time Frame: 3-12 months ]
    The coefficient of variation (CV) of tacrolimus trough levels at 3 months and at 12 months will be assessed. We will compare the proportion of patients with CV ≥ 30% at 3 months and at 12 months. The 12-month measurement will be assessed in all patients including patients who receive care in peripheral transplant centers as this information is readily accessible in our electronic records. These measures will also help to address the long-term durability of any change in adherence related to the interventions.

  3. Proportion of patients within target tacrolimus trough levels [ Time Frame: 3-12 months ]
    Proportion of patients within target tacrolimus trough levels at 3 months and at 12 months.

  4. Comparison of post-transplant test results between intervention and control group [ Time Frame: 3 months ]

    Comparison of post-transplant test results between intervention and control group using a Long-term Medication Behaviour Self-efficacy Scale. The scale has 5 possible answers that reflect the extent that the participant is able to take their medications correctly in the described situations.

    1. unlikely
    2. maybe, maybe not
    3. probably yes
    4. most probably
    5. certainly

  5. Medication Behaviour for intervention group only [ Time Frame: 3 months ]

    Comparison of post-transplant test results between intervention and control group using a Long-term Medication Behaviour Self-efficacy Scale. The scale has 5 possible answers that reflect the extent that the participant is able to take their medications correctly in the described situations.

    1. unlikely
    2. maybe, maybe not
    3. probably yes
    4. most probably
    5. certainly

  6. Staff resource utilization [ Time Frame: Through study completion, an average of 1 year ]
    Time spent with patient education + re-education + discharge planning + resolving medication errors + arranging for medication management. The post-transplant team will receive an inservice to ensure accurate and complete documentation of their time spent on the above activities.

  7. Medication nonadherence-related hospital readmissions [ Time Frame: 12 months ]
    Medication nonadherence-related hospital readmissions will be assessed for 12 months after transplantation by review of all hospitalization records.

  8. Biopsy proven acute rejection (BPAR) rate [ Time Frame: 12 months ]
    Biopsy proven acute rejection (BPAR) rate at 12 months

  9. Kidney allograft function [ Time Frame: 12 months ]
    Kidney allograft function (SCr, UACR) at 12 months

  10. Kidney allograft survival [ Time Frame: 12 months ]
    Kidney allograft survival at 12 months

  11. Patient survival [ Time Frame: 12 months ]
    Patient survival at 12 months

  12. Health Literacy for intervention group only [ Time Frame: 3 months ]
    This group will also undergo health literacy surveys which associates answers with values of 1-5: A lower score indicates lower health literacy.

  13. Montreal Cognitive Assessment for intervention group only [ Time Frame: 3 months ]
    Cognition will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-question screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kidney transplant candidates anticipated to undergo transplantation from a deceased or living donor within 6 months of enrolment

Exclusion Criteria:

  • There are no exclusion criteria. All eligible patients will be approached by a research assistant. Patients with limited English language fluency will be asked to participate with the assistance of a translator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078750


Contacts
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Contact: Marianna Leung, Pharm D 7787887468 MLeung@providencehealth.bc.ca
Contact: Breanna Riou-Green, BSc 6046822344 ext 64708 briougreen@providencehealth.bc.ca

Locations
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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Cindy Y Luo, Pharm D    6043414264    Cindy.Luo@vch.ca   
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Marianna Leung, Pharm D    7787887468    MLeung@providencehealth.bc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Marianna Leung, Pharm D St. Paul's Hospital
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Responsible Party: John Gill, Professor of Medicine, Division of Nephrology, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT04078750    
Other Study ID Numbers: H19-02030
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency