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

NCT ID: NCT06106854

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2022-09-15

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.

Detailed Description

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Conditions

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Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Group Type EXPERIMENTAL

Behavioral: SystemCHANGE

Intervention Type BEHAVIORAL

six-month SystemCHANGE™ intervention

Control

Group Type PLACEBO_COMPARATOR

Education

Intervention Type OTHER

Six patient education booklets

Interventions

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Behavioral: SystemCHANGE

six-month SystemCHANGE™ intervention

Intervention Type BEHAVIORAL

Education

Six patient education booklets

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Yaprak S. Ordin

Associate Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yaprak Sarıgöl Ordin

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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218S720

Identifier Type: -

Identifier Source: org_study_id

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