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Clinical Trials/NCT06004102
NCT06004102
Completed
Not Applicable

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

Akdeniz University Hospital1 site in 1 country100 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Medication Adherence
Sponsor
Akdeniz University Hospital
Enrollment
100
Locations
1
Primary Endpoint
The effect of sending reminder text messages on immunosuppressive medication adherence
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
February 8, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Akdeniz University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kübra Erdal

Nurse

Akdeniz University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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