The Effect of the 5th Sign Intervention on Medication Adherence in Kidney Transplant Recipients

NCT07851142 | Completed DMC

• 2 other identifiers: 2022/22-14TCD-2023-3201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant; Mobile Applications; Drug-Related Side Effects and Adverse Reactions (MeSH Term); Medication Adherence

Keywords

kidney transplantation; medication adherence; immunosuppressive agents; mobile applications; drug-related side effects and adverse reactions

Outcome Measures

Primary Outcomes (3)

• Biological Medication Adherence Rate

  The rate of immunosuppressive medication adherence assessed through objective biological data (e.g., blood trough levels) among kidney transplant recipients.

  At Baseline and 6 months

• Self-Reported Medication Adherence Rate

  The rate of medication adherence evaluated using self-report questionnaires completed by the patients.

  At Baseline and 6 months

• Mobile Monitoring-Based Medication Adherence Rate

  The longitudinal adherence for experimental group to the medication regimen, tracked and recorded via the mobile health monitoring application.

  Continuous monitoring over a 6-month period

Secondary Outcomes (4)

• Incidence of Immunosuppressive Drug-Related Side Effects

  At Baseline and 6 months

• Clinical Health Outcomes

  At Baseline and 6 months

• Clinical Health Outcomes

  At Baseline and 6 months

• Clinical Health Outcomes

  At Baseline and 6 months

Study Arms (2)

5th Sign Intervention Group

EXPERIMENTAL

The intervention was developed based on the Social Ecological Model (SEM) and the Plan-Do-Check-Act (PDCA) cycle. It aimed to improve adherence to immunosuppressive medication through individualized education, goal setting, personalized action plans, routine monitoring of medication adherence, and regular counseling supported by a mobile health application. The intervention addressed individual, interpersonal, and healthcare system levels by promoting patient self-management and communication with healthcare professionals.

Behavioral: 5th Sign Intervention Program

Standart Care Group

NO INTERVENTION

In the control group, participants attended scheduled educational sessions at baseline and during Months 1, 2, and 3, with the same frequency and duration as the intervention group. These sessions were based on the educational materials routinely used in the clinic and covered general topics related to post-transplant self-care, including transplant follow-up, healthy lifestyle, nutrition, exercise, and prevention of post-transplant complications. The educational sessions did not include any structured intervention specifically designed to improve immunosuppressive medication adherence, and participants did not have access to the study mobile health application. Questions related to routine post-transplant care were addressed according to standard clinical practice. No structured educational or counseling sessions were provided during Months 4-5. At Month 6, baseline assessments were repeated, and the study was concluded following the final assessment.

Interventions

5th Sign Intervention Program BEHAVIORAL

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.

5th Sign Intervention Group

Eligibility Criteria

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

You may qualify if:

• Being 18 years of age or older
• Voluntarily agreeing to participate
• Having undergone kidney transplantation at least 6 months previously
• Being a smartphone user
• Receiving tacrolimus twice daily
• Having adequate cognitive function. Cognitive function was assessed using the Standardized Mini-Mental State Examination (SMMSE). Patients with ≥5 years of formal education were classified as educated and were eligible if they scored 23 or higher, whereas patients with \<5 years of formal education were eligible if they scored 19 or higher on the SMMSE.

You may not qualify if:

• Having undergone multiple organ transplantation
• Having received a retransplantation
• Having been diagnosed within the previous month with a condition requiring modification of the immunosuppressive treatment regimen (e.g., cancer, tuberculosis, or infection)
• Being pregnant or planning a pregnancy
• Having a diagnosed psychiatric disorder
• Having cognitive impairment
• Being hospitalized at the time of enrollment

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Medication Adherence; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Chemically-Induced Disorders

Study Officials

• Yaprak Sarıgöl Ordin, Prof. Dr.

  Dokuz Eylul University

  STUDY CHAIR

• Caner Çavdar, Prof. Dr.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Büşra S Saha, PhD, RN

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: October 1, 2026
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 6 months after publication of the primary study results and ending 36 months after publication.
• Access Criteria: De-identified data will be available to qualified researchers who provide a methodologically sound research proposal. Requests will be reviewed by the principal investigator.

Locations

TU (1)