Medication Adherence Plan for Kidney Transplant Rejection

Recruiting at 1 trial location

Overseen By Marianna Leung, Pharm D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

99 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marianna Leung, Pharm D

Principal Investigator

St. Paul's Hospital

Eligibility Criteria

This trial is for kidney transplant candidates expected to receive a new organ within the next 6 months. It's designed to help those who might struggle with taking their medication regularly, which is crucial for the success of the transplant.

Inclusion Criteria

I am expected to have a kidney transplant within the next 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-transplant Assessment

Interventional group undergoes a 1-month adherence trial with mock immunosuppressant medication and various assessments including health literacy, cognition, and self-efficacy.

1 month

Multiple visits (in-person and phone calls)

Post-transplant Monitoring

Both groups receive tacrolimus capsules in MEMS caps for 3 months to measure adherence. Patients complete BAASIS and self-efficacy questionnaires.

3 months

Regular follow-up visits

Follow-up

Participants are monitored for kidney function, rejection rates, and adherence over a longer term.

12 months

Treatment Details

Interventions

• Tailored medication adherence plan

Trial Overview The study tests a tailored plan to improve how patients take their immunosuppressant drugs after a kidney transplant versus usual care. One group will be monitored and given a personalized adherence strategy before and after surgery; outcomes like kidney function and rejection rates will be compared.

Participant Groups

Group I: Phase II. Intervention group Experimental Treatment 1 Intervention

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.

Group II: Phase I. Control group Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+