Medication Adherence in Kidney Transplant

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06004102
• Other study ID #: KAEK-315
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 8, 2023

Study information

• Verified date: August 2023
• Source: Akdeniz University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 8, 2023
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Medication Adherence

Intervention

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

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya	Konyaalti

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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