Medication Adherence in Kidney Transplant

August 25, 2023 updated by: Kübra Erdal, Akdeniz University Hospital

Impact of Text Message Reminders on Immunosuppressive Medication Adherence Among Kidney Transplant Recipients: A Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Konyaalti
      • Antalya, Konyaalti, Turkey, 07058
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: reminder text message
The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of sending reminder text messages on immunosuppressive medication adherence
Time Frame: baseline and 9 months
The IMAS is a validated an 11-item self-report questionnaire developed in 2015 to measure medication adherence in patients that have received solid organ transplants and are prescribed immunosuppressive drugs.
baseline and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

February 8, 2023

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KAEK-315

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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