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

Sponsor
Dokuz Eylul University (Other)
Overall Status
Completed
CT.gov ID
NCT06106854
Collaborator
The Scientific and Technological Research Council of Turkey (Other)
42
Enrollment
1
Location
2
Arms
36
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral: SystemCHANGE
  • Other: Education
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Sep 16, 2019
Actual Primary Completion Date :
Sep 15, 2022
Actual Study Completion Date :
Sep 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Behavioral: Behavioral: SystemCHANGE
six-month SystemCHANGE™ intervention
Placebo Comparator: Control

Other: Education
Six patient education booklets

Outcome Measures

Primary Outcome Measures

  1. medication adherence [12-months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yaprak Sarıgöl Ordin İzmir Turkey 35240

Sponsors and Collaborators

  • Dokuz Eylul University
  • The Scientific and Technological Research Council of Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yaprak S. Ordin, Associate Professor Doctor, Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT06106854
Other Study ID Numbers:
  • 218S720
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yaprak S. Ordin, Associate Professor Doctor, Dokuz Eylul University
medication adherence
immunosuppressive medications
adult kidney transplant recipients
nursing
SystemCHANGE

Study Results

No Results Posted as of Oct 30, 2023