Medication Adherence in Kidney Transplant

NCT ID: NCT06004102

Last Updated: 2023-08-29

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-02-08

Brief Summary

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Aims and Objective: The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.

Background: One of the most common problems encountered in transplant patients is incompatibility with immunosuppressive drugs, one of the most important reasons for graft rejection.

Design: A randomized controlled trial was conducted from January to October 2021 and conducted in accordance with the Consolidated Standards of Reporting Trials 2010 guidelines.

Methods: This randomized controlled trial included a total of 100 patients receiving a kidney transplant, 50 in the intervention group and 50 in the control group. Patients in the intervention group were sent text message reminders four times a day during the 6th to 9th months after transplantation. Control patients received no such intervention. Tacrolimus concentrations in the bloodstream were monitored for all participants through measurements taken at months 7,8, and 9. Data collection tools included Sociodemographic and Descriptive Characteristics Form and Immunosuppressive Medication Adherence Scale.

Research hypotheses H1- Sending text message reminders improves immunosuppressive medication adherence in kidney transplant recipients.

H2- Utilization of text messages as reminders has a significant influence on tacrolimus blood profiles in kidney transplant recipients.

H3- There is a correlation between the scores from the Immunosuppressive Medication Adherence Scale and mean tacrolimus plasma levels in kidney transplant recipients.

H4- There is a correlation between the sociodemographic and descriptive characteristics of kidney transplant recipients and their mean scores from the Immunosuppressive Medication Adherence Scale.

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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reminder text message

At the baseline of the study, the Sociodemographic and Descriptive Characteristics Form and IMAS were administered to patients in the intervention groups as a pretest. Short text messages to remind the use of immunosuppressive medication and educational text messages were sent to patients in the intervention group four times a day, every day for three months. The intervention group also received educational text messages three days a week, in addition to such text message reminders.

The text message contents prepared for the intervention group were sent automatically to patients at specified times via the purchased program. At the end of the study, intervention groups of participants completing the 9-month follow-up were administered the IMAS questionnaire as a posttest.

Group Type EXPERIMENTAL

reminder text message

Intervention Type OTHER

The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.

no intervention

At the baseline of the study, the Sociodemographic and Descriptive Characteristics Form and IMAS were administered to patients in the control groups as a pretest. The control group did not receive any such intervention. At the end of the study, control groups of participants completing the 9-month follow-up were administered the IMAS questionnaire as a posttest.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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reminder text message

The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Being a recipient of a kidney transplant for the first time
* Being a kidney transplant recipient at post-transplant month 6 with scheduled follow-up until month 9
* Ongoing immunosuppressive drug therapy
* Absence of any disability that hinders communication
* No diagnosis of psychological and mental problems
* Being an active cell phone user
* Ability to read and write
* Voluntary participation in the research.

Exclusion Criteria

* Hospitalization for any reason during the research period
* History of combined or dual organ transplantation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kübra Erdal

Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akdeniz University

Antalya, Konyaalti, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KAEK-315

Identifier Type: -

Identifier Source: org_study_id

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