Medication Adherence in Kidney Transplant Patients: SystemCHANGE™ Results of the Turkish MAGIC Randomized Clinical Trial

Study Overview
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Brief Summary
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The SystemCHANGETM intervention harnesses patients' established daily routines/habits, environment, and important others, as possible solutions that are reoccurring and thus reliable systems that could support medication taking to become a dependable routine/habit. The aim of this study was to evaluate the effect of a six-month SystemCHANGE™ intervention compared to a six-month attention-control education intervention on medication adherence in adult kidney transplant recipients.

Official Title
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Improving Medication Adherence and Outcomes in Turkish Adult Kidney Transplant Patients Using a Personal Systems Approach: SystemCHANGE™ Results of the Turkish MAGIC Randomized Clinical Trial

Conditions
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Medication Adherence

Intervention / Treatment
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* Behavioral: Behavioral: SystemCHANGE
* Other: Education


Participation Criteria
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Eligibility Criteria
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The inclusion criteria were patients having only kidney transplantation, aged 18 years or older, taking only immunosuppressant therapy twice daily, not staying in hospital and not diagnosed with a disease shortening their life span. They also were required to own a telephone, use an electronic medication cap and bottle, understand and speak Turkish, and have approval from their nephrologist to participate in the study. They were also assessed in person for cognitive impairment using the Standardized Mini Mental Test. Those who received a 23 or higher score on the test were enrolled in the study sample.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Behavioral: SystemCHANGE<br>* six-month SystemCHANGE™ intervention<br>|
| Placebo Comparator: Control<br> | Other: Education<br>* Six patient education booklets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medication adherence | The six-month maintenance phase followed the intervention phase. In this phase, the patients continued to use the electronic medication monitoring cap and bottle. They were not contacted by the researcher until the completion of the six-month maintenance phase when they were contacted to return their electronic medication monitoring cap and Medication Event Monitoring System (MEMS) diary. | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication adherence, immunosuppressive medications, adult kidney transplant recipients, nursing, SystemCHANGE