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Completed

NCT Number: NCT06106854

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

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.

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Key information

Conditions

Medication Adherence Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yaprak Sarıgöl Ordin

Izmir, 35240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral: SystemCHANGE

Behavioral

six-month SystemCHANGE™ intervention

Education

Other

Six patient education booklets

Primary outcomes

  1. medication adherence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2023
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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