Clinical Research Directory
Browse clinical research sites, groups, and studies.
The Effect of the 5th Sign Intervention on Medication Adherence in Kidney Transplant Recipients
Sponsor: Dokuz Eylul University
Summary
The goal of this randomized controlled trial is to evaluate the effectiveness of the "5th Sign" intervention program-a multi-component strategy based on the Socio-Ecological Model that incorporates goal setting, action planning, medication education, problem-solving, and counseling, delivered via a custom mobile health application. The main questions it aims to answer are: * To examine the effect of the 5th Sign intervention on immunosuppressive medication adherence (measured biologically, via self-report, and mobile monitoring) in kidney transplant recipients. * To evaluate the effect of the intervention on clinical health outcomes, specifically including infection, mortality, Blood Urea Nitrogen (BUN) and creatinine levels, acute/chronic rejection, and graft loss. * To assess the effect of the intervention on the incidence of immunosuppressive drug-related side effects. Researchers will evaluate the 5th Sign intervention to see if the mobile health app and structured counseling are effective in improving medication adherence and patient outcomes. Participants will: * Be randomly assigned to either the intervention group (using the 5th Sign intervention) or the control group for a total study period of 6 months. * (If in the intervention group) Participate in active counseling and interviews for the first 3 months, followed by a 3-month monitoring period. * (If in the intervention group) Use the mobile health application continuously for 6 months for medication reminders and tracking, with their app usage evaluated on a monthly basis. * Complete questionnaires (regarding medication usage and side effects) and provide blood samples (to measure biological adherence and kidney function) twice: at the beginning of the study and at the end of the 6-month study period.
Official title: The Effect of the 5th Sign Intervention on Medication Adherence in Kidney Transplant Recipients: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-05-01
Completion Date
2025-12-31
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
5th Sign Intervention Program
The 5.BULGU intervention consisted of four phases. Step 1 (Month 0): Medication adherence and mobile application acceptance were assessed, and individual barriers and support needs were identified. A 100% medication adherence target and an individualized action plan were established, followed by training on the mobile health application and medication-related education. Step 2 (Months 1-3): Patients actively used the application for medication adherence monitoring, feedback, reminders, educational content, and motivational notifications. Monthly follow-up sessions included evaluation of adherence reports, identification of barriers, problem-solving, and counseling. Step 3 (Months 4-6): Patients transitioned to independent application use, while medication adherence monitoring continued and scheduled counseling sessions were discontinued. Step 4 (Month 6): Baseline assessments were repeated, and patient experiences were evaluated at the end of the intervention.
Locations (1)
Dokuz Eylül University
Izmir, Balçova, Turkey (Türkiye)