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CompletedNCT06106854Updated Oct 30, 2023

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

An interventional study of Behavioral: SystemCHANGE and Education in Medication Adherence, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-30.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled Sep 2019, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Medication Adherence

Keywords

  • medication adherence
  • immunosuppressive medications
  • adult kidney transplant recipients
  • nursing
  • SystemCHANGE
03

In context

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Intervention

    Behavioral: Behavioral: SystemCHANGE

  • Placebo comparator
    Control

    Other: Education

Interventions

  • BehavioralBehavioral: SystemCHANGE

    six-month SystemCHANGE™ intervention

  • OtherEducation

    Six patient education booklets

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12-months

07

Study locations

1 site
  • Yaprak Sarıgöl Ordin
    İzmir, 35240, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06106854
Lead sponsor
Dokuz Eylul University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
Yaprak S. Ordin (Associate Professor Doctor, Dokuz Eylul University) — Principal investigator
First posted
Oct 30, 2023
Start date
Sep 16, 2019
Primary completion
Sep 15, 2022
Completion
Sep 15, 2022
Last update
Oct 30, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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