Medication Adherence in Kidney Transplant

NCT06004102 | Completed

• 1 other identifier: KAEK-315
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence

Keywords

kidney transplantation; reminder text messages; medication adherence; surgical nursing

Outcome Measures

Primary Outcomes (1)

• The effect of sending reminder text messages on immunosuppressive medication adherence

  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

Study Arms (2)

reminder text message

EXPERIMENTAL

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

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.

Interventions

reminder text message OTHER

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

reminder text message

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hospitalization for any reason during the research period
• History of combined or dual organ transplantation.

Sponsors & Collaborators

• Akdeniz University Hospital: lead

Study Sites (1)

Akdeniz University

Antalya, Konyaalti, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 22, 2023
• Study Start: January 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: February 8, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

TU (1)