Medication Adherence Clinical Trial
Official title:
Pre-Transplant Multidisciplinary Assessment on Medication Adherence and Transplant Outcomes
Verified date | May 2024 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 99 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Self-reported adherence rates as measured by BAASIS | 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). | 3-12 months | |
Secondary | The coefficient of variation (CV) of tacrolimus trough levels | 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. | 3-12 months | |
Secondary | Proportion of patients within target tacrolimus trough levels | Proportion of patients within target tacrolimus trough levels at 3 months and at 12 months. | 3-12 months | |
Secondary | Comparison of post-transplant test results between intervention and control group | 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.
unlikely maybe, maybe not probably yes most probably certainly |
3 months | |
Secondary | Medication Behaviour for intervention group only | 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.
unlikely maybe, maybe not probably yes most probably certainly |
3 months | |
Secondary | Staff resource utilization | 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. | Through study completion, an average of 1 year | |
Secondary | Medication nonadherence-related hospital readmissions | Medication nonadherence-related hospital readmissions will be assessed for 12 months after transplantation by review of all hospitalization records. | 12 months | |
Secondary | Biopsy proven acute rejection (BPAR) rate | Biopsy proven acute rejection (BPAR) rate at 12 months | 12 months | |
Secondary | Kidney allograft function | Kidney allograft function (SCr, UACR) at 12 months | 12 months | |
Secondary | Kidney allograft survival | Kidney allograft survival at 12 months | 12 months | |
Secondary | Patient survival | Patient survival at 12 months | 12 months | |
Secondary | Health Literacy for intervention group only | This group will also undergo health literacy surveys which associates answers with values of 1-5: A lower score indicates lower health literacy. | 3 months | |
Secondary | Montreal Cognitive Assessment for intervention group only | 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. | 3 months |
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