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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06106854
• Other study ID #: 218S720
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: September 15, 2022

Study information

• Verified date: September 2023
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Behavioral:
• Behavioral: SystemCHANGE
six-month SystemCHANGE™ intervention

Other:
• Education
Six patient education booklets

Locations

Country	Name	City	State
Turkey	Yaprak Sarigöl Ordin	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Dokuz Eylul University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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