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Completed

NCT Number: NCT06004102

Medication Adherence in Kidney Transplant

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.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, Konyaalti, 07058, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

reminder text message

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Akdeniz University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Aug 22, 2023
Registry last updated
Aug 29, 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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