PLATO - Medication Adherence in Transplant Recipients

NCT04078750 | Active Not Recruiting

• 1 other identifier: H19-02030
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Disease, Chronic; Medication Adherence; Renal Disease; Kidney Rejection Transplant

Outcome Measures

Primary Outcomes (1)

• Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps.

  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.

  3 month duration

Secondary Outcomes (13)

• Self-reported adherence rates as measured by BAASIS

  3-12 months

• The coefficient of variation (CV) of tacrolimus trough levels

  3-12 months

• Proportion of patients within target tacrolimus trough levels

  3-12 months

• Comparison of post-transplant test results between intervention and control group

  3 months

• Medication Behaviour for intervention group only

  3 months

Study Arms (2)

Phase I. Control group

SHAM COMPARATOR

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

Phase II. Intervention group

EXPERIMENTAL

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

Interventions

Tailored medication adherence plan BEHAVIORAL

Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps.

Phase I. Control group; Phase II. Intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Medication Adherence; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marianna Leung, Pharm D

  St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Division of Nephrology, Principal Investigator

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: September 6, 2019
• Study Start: September 10, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)