Kidney TransplantNCT07851142
The Effect of the 5th Sign Intervention on Medication Adherence in Kidney Transplant Recipients
A study testing 5th Sign Intervention Program in people with Kidney Transplant and Drug-Related Side Effects and Adverse Reactions (MeSH Term), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Drug-Related Side Effects and Adverse Reactions (MeSH Term), Medication Adherence
- What is being tested?
- 5th Sign Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the 5th Sign Intervention on Medication Adherence in Kidney Transplant Recipients: A Randomized Controlled Trial
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:
Read more
- 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.
Read the detailed description
Background and Rationale:
While kidney transplantation provides superior survival rates and cost-effectiveness compared to other renal replacement therapies, long-term graft survival depends heavily on strict, lifelong adherence to immunosuppressive medication. Despite its critical importance, medication non-adherence remains a progressively worsening risk factor in post-transplant clinical follow-up, leading to severe adverse effects, rejection, and graft loss. To address this, the Consensus on Managing Modifiable Risk in Transplantation (COMMIT) expert group strongly advocates for integrating adherence monitoring into routine care, designating it as the "fifth vital sign."
Theoretical Framework: To effectively manage the complex nature of medication non-adherence, this study employs a multi-component, technology-based intervention. The 5th Sign intervention is theoretically grounded in Urie Bronfenbrenner's Socio-Ecological Model, structuring support mechanisms across multiple levels of the patient's environment (goal setting, action planning, problem-solving, and counseling). Furthermore, the implementation, continuous evaluation, and sustainability of the intervention are guided by W. Edwards Deming's Plan-Do-Check-Act cycle.
Intervention Mechanics and Application Development: The core of the study is a custom-developed mobile health application integrated with a structured follow-up program. The application's architecture was shaped by a preliminary empirical needs assessment conducted with kidney transplant patients, which identified a critical demand for medication reminders and usage reporting features. Consequently, the application includes automated medication reminders, dose tracking, drug education modules, and direct communication channels with healthcare professionals.
Procedural Implementation:
The intervention is structured over a 6-month period, divided into two distinct operational phases for the experimental group:
- Active Intervention Phase (Months 1-3): Participants engage in comprehensive, multidimensional counseling and structured interviews. Concurrently, they actively use the mobile application to manage their medication regimens.
- Monitoring Phase (Months 4-6): Active counseling is concluded, and participants transition into a monitoring period where they continue to use the mobile application independently.
- Conditions
- Kidney Transplant, Drug-Related Side Effects and Adverse Reactions (MeSH Term), Medication Adherence, Mobile Applications
- Being tested
- 5th Sign Intervention Program
- Keywords
- kidney transplantation, medication adherence, immunosuppressive agents, mobile applications, drug-related side effects and adverse reactions
- Medical subject headings
- Medication Adherence, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5th Sign Intervention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological Medication Adherence Rate
The rate of immunosuppressive medication adherence assessed through objective biological data (e.g., blood trough levels) among kidney transplant recipients.
Measured: At Baseline and 6 months
Self-Reported Medication Adherence Rate
The rate of medication adherence evaluated using self-report questionnaires completed by the patients.
Measured: 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.
Measured: Continuous monitoring over a 6-month period
Secondary outcomes (4)
Incidence of Immunosuppressive Drug-Related Side Effects
The frequency and severity of adverse side effects associated with immunosuppressive therapy in kidney transplant recipients.
Measured: At Baseline and 6 months
Clinical Health Outcomes
Assessment of graft health by measuring Blood Urea Nitrogen (BUN) levels in mg/dL
Measured: At Baseline and 6 months
Clinical Health Outcomes
Assessment of graft health by measuring serum creatinine levels in mg/dL.
Measured: At Baseline and 6 months
Clinical Health Outcomes
The number of participants experiencing acute or chronic graft rejection.
Measured: At Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 May 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaprak S. Ordin, Dokuz Eylul University
- Investigators
- Yaprak Sarıgöl Ordin, Prof. Dr., Study chair, Dokuz Eylul UniversityCaner Çavdar, Prof. Dr., Principal investigator, Dokuz Eylul UniversityBüşra S Saha, PhD, RN, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851142
- Sponsor's protocol ID
- 2022/22-14
- Other IDs
- TCD-2023-3201
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary publication will be shared. The dataset will include demographic characteristics, medication adherence outcomes, and relevant clinical outcome data collected during the study. The study protocol, and dınformed consent form will also be made available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the 5th Sign Intervention on Medication Adherence in Kidney Transplant Recipients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07851142
- Acronym / sponsor ID
- 2022/22-14
- Conditions
- Kidney Transplant, Drug-Related Side Effects and Adverse Reactions (MeSH Term), Medication Adherence, Mobile Applications
- Keywords
- kidney transplantation, medication adherence, immunosuppressive agents, mobile applications, drug-related side effects and adverse reactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:
While kidney transplantation provides superior survival rates and cost-effectiveness compared to other renal replacement therapies, long-term graft survival depends heavily on strict, lifelong adherence to immunosuppressive medication. Despite its critical importance, medication non-adherence remains a progressively worsening risk factor in post-transplant clinical follow-up, leading to severe adverse effects, rejection, and graft loss. To address this, the Consensus on Managing Modifiable Risk in Transplantation (COMMIT) expert group strongly advocates for integrating adherence monitoring into routine care, designating it as the "fifth vital sign."
Theoretical Framework: To effectively manage the complex nature of medication non-adherence, this study employs a multi-component, technology-based intervention. The 5th Sign intervention is theoretically grounded in Urie Bronfenbrenner's Socio-Ecological Model, structuring support mechanisms across multiple levels of the patient's environment (goal setting, action planning, problem-solving, and counseling). Furthermore, the implementation, continuous evaluation, and sustainability of the intervention are guided by W. Edwards Deming's Plan-Do-Check-Act cycle.
Intervention Mechanics and Application Development: The core of the study is a custom-developed mobile health application integrated with a structured follow-up program. The application's architecture was shaped by a preliminary empirical needs assessment conducted with kidney transplant patients, which identified a critical demand for medication reminders and usage reporting features. Consequently, the application includes automated medication reminders, dose tracking, drug education modules, and direct communication channels with healthcare professionals.
Procedural Implementation:
The intervention is structured over a 6-month period, divided into two distinct operational phases for the experimental group:
- Active Intervention Phase (Months 1-3): Participants engage in comprehensive, multidimensional counseling and structured interviews. Concurrently, they actively use the mobile application to manage their medication regimens.
- Monitoring Phase (Months 4-6): Active counseling is concluded, and participants transition into a monitoring period where they continue to use the mobile application independently.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5th Sign Intervention Group | Experimental | Behavioral: 5th Sign Intervention ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5th Sign Intervention ProgramThe 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. | Behavioural | 5th Sign Intervention Group |
Primary outcome
Biological Medication Adherence Rate
Time frame: At Baseline and 6 months
The rate of immunosuppressive medication adherence assessed through objective biological data (e.g., blood trough levels) among kidney transplant recipients.
Self-Reported Medication Adherence Rate
Time frame: At Baseline and 6 months
The rate of medication adherence evaluated using self-report questionnaires completed by the patients.
Mobile Monitoring-Based Medication Adherence Rate
Time frame: Continuous monitoring over a 6-month period
The longitudinal adherence for experimental group to the medication regimen, tracked and recorded via the mobile health monitoring application.
4 secondary outcomes
Incidence of Immunosuppressive Drug-Related Side Effects
Time frame: At Baseline and 6 months
Clinical Health Outcomes
Time frame: At Baseline and 6 months
Clinical Health Outcomes
Time frame: At Baseline and 6 months
Clinical Health Outcomes
Time frame: At Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the primary publication will be shared. The dataset will include demographic characteristics, medication adherence outcomes, and relevant clinical outcome data collected during the study. The study protocol, and dınformed consent form will also be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaprak Sarıgöl Ordin, Prof. Dr. study chair
Dokuz Eylul University
Caner Çavdar, Prof. Dr. principal investigator
Dokuz Eylul University
Büşra S Saha, PhD, RN principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5th Sign Intervention Program in people with Kidney Transplant and Drug-Related Side Effects and Adverse Reactions (MeSH Term), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological Medication Adherence Rate (time frame: At Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.