Organ TransplantationNCT07288918
The Effect of Education on Quality of Life, Adherence to Immunosuppressive Therapy and Symptom Control in Organ Transplant Patients
A study testing Mobile application installation and Providing teaching booklets in people with Organ Transplantation and Mobile Applications, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Organ transplantation is the most effective method for treating end-stage organ failure and allows patients on the verge of death to continue living. Organ transplantation involves removing all or part of an organ or tissue from the body and transplanting it to suitable patients experiencing failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Transplantation, Mobile Applications, Nursing
- What is being tested?
- Mobile application installation and Providing teaching booklets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 over 18 years of age,
- Having undergone a liver or kidney transplant for the first time,
- Having been discharged at least three months ago,
- Having access to a smartphone and internet and the ability to use them independently,
Who cannot join
- Having a diagnosis of a psychiatric or neurological disorder,
- Having hearing or vision problems severe enough to impede communication,
- Requesting to leave during the research period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ondokuz Mayis University
Samsun, Samsun
Rıfat GÜRKAN, +905067154895, rifatgurkannn@gmail.com
About this study
Official title: The Effects of Different Educational Methods Given to Patients Undergoing Organ Transplantation on Quality of Life, Compliance With İmmunosuppressive Therapy and Symptom Control
Organ transplantation is the most effective method for treating end-stage organ failure and allows patients on the verge of death to continue living. Organ transplantation involves removing all or part of an organ or tissue from the body and transplanting it to suitable patients experiencing failure. Therefore, transplants are performed to treat diseases, save lives, improve patients' quality of life, and extend their life expectancy. The World Health Organization (WHO) defines quality of life as individuals' perceptions of their goals, expectations, standards, and concerns regarding their place in life, within the context of the culture and value systems they live in. Achieving an adequate quality of life after transplantation is considered an indicator of therapeutic success, which is increasingly important to measure by the transplant care team.
Individuals who undergo transplantation and their families often perceive transplantation as a rebirth. However, 30% to 40% of patients report no better health-related quality of life after kidney transplantation compared to dialysis. This is attributed to frequent checkups and monitoring, new medications and their strict dosing schedules, and the unexpected discomfort of potential side effects.
Read more
Even after the psychological challenges of waiting and the joy of a successful transplant, transplant recipients take on new responsibilities. Problems such as accepting transplantation risks, acute and chronic organ rejection, and adherence to lifelong medication regimens can arise. Persistent side effects of various immunosuppressive agents, adaptation and maintenance of the new organ, and uncertainty about the future due to rejection of transplanted organs and the subsequent re-transplantation process can all lead to physical and psychological distress.
Immunosuppressive therapy represents a lifelong endeavor for transplant recipients. These medication regimens involve complex protocols, not only due to the number of pills required, but also due to blood level monitoring, side effects, and frequent dose adjustments to avoid rejection. Non-adherence to immunosuppressant regimens has been shown to be high in organ transplant patients. Non-adherence rates in this population are reported as high as 65%. The highest immunosuppressant non-adherence rate is found in kidney transplant recipients, with a prevalence of 36-55%, while this rate is 15-40% in liver transplant recipients. Studies have found that 16-36% of graft losses are associated with non-adherence. The ever-growing population of transplant recipients and the limited number of transplant centers, particularly those living farther away, necessitate innovative healthcare delivery models to monitor and improve the use of transplant center resources. With the advent of smartphones and mobile medical devices, mobile health has become a popular way for healthcare professionals to manage patient care. Mobile health can serve as an adjunct method for delivering health education information, sending reminders to patients to take their medications, and implementing online education. In particular, converting paper-based education to video format can significantly increase knowledge on various topics. It is necessary to address the problems and challenges patients face after discharge and the practices that can potentially address these issues. These results suggest that healthcare professionals can do more to provide comprehensive care to patients, promote successful home-based treatment regimens, symptom control, and quality of life.
- Conditions
- Organ Transplantation, Mobile Applications, Nursing
- Being tested
- Mobile application installation, Providing teaching booklets, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application installationOther
Transplant patients will receive standard discharge training. A mobile application created by the researcher will be installed on transplant patients' phones.
Providing teaching bookletsOther
Transplant patients will receive standard discharge training. Transplant patients will be given researcher prepared instructional booklet
ControlOther
Transplant patients will receive standard discharge training
| Study group | Role | What they receive |
|---|---|---|
| Mobile applications | Experimental | Not described Receives: Other: Mobile application installation |
| Teaching booklet | Experimental | Not described Receives: Other: Providing teaching booklets |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of education on quality of life in organ transplant patients
The SF-36 Quality of Life Scale will be administered before the training intervention. Most questions on the scale use Likert-type rating scales (3, 5, and 6 points), while questions four and five can be answered with yes/no. Each section of the scale is rated between 0 and 100 points. Higher scores indicate better health, or improved quality of life ("0" for poor health, "100" for good health).
Measured: Baseline, and 1, 3, and 6 months post-intervention.
The effect of education on symptom control in organ transplant patients
The Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 will be administered before the training intervention. Each item on the scale corresponds to a side effect of immunosuppressive drugs, and these items have two dimensions that assess symptom occurrence and discomfort level. Symptom occurrence is scored from 1 to 5, with 1=never occurring and 5=always occurring. Symptom discomfort level is scored from 0 to 4, with 0=never causing discomfort and 4=causing extreme discomfort.
Measured: Baseline, and 1, 3, and 6 months post-intervention.
The effect of education on adherence to ımmunosuppressive therapy in organ transplant patients
The Immunosuppressant Therapy Adherence Scale in Organ Transplantation Patients will be administered before the training intervention. The scale consists of four questions, and participants can receive a score between 0 and 12. Individuals who have not forgotten their immunosuppressive treatment in the last three months are given 3 points, those with 1-20% non-adherence to immunosuppressive treatment are given 2 points, those with 21-50% non-adherence to immunosuppressive treatment are given 1 point, and those with >50% non-adherence to immunosuppressive treatment are given 0 points.
Measured: Baseline, and 1, 3, and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start10 Dec 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantationStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rıfat GÜRKAN, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288918
- Sponsor's protocol ID
- OMU-GURKAN-001
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Educational Methods Given to Patients Undergoing Organ Transplantation on Quality of Life, Compliance With İmmunosuppressive Therapy and Symptom Control
- ClinicalTrials.gov ID
- NCT07288918
- Acronym / sponsor ID
- OMU-GURKAN-001
- Conditions
- Organ Transplantation, Mobile Applications, Nursing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 17 Dec 2025 (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.
Organ transplantation is the most effective method for treating end-stage organ failure and allows patients on the verge of death to continue living. Organ transplantation involves removing all or part of an organ or tissue from the body and transplanting it to suitable patients experiencing failure. Therefore, transplants are performed to treat diseases, save lives, improve patients' quality of life, and extend their life expectancy. The World Health Organization (WHO) defines quality of life as individuals' perceptions of their goals, expectations, standards, and concerns regarding their place in life, within the context of the culture and value systems they live in. Achieving an adequate quality of life after transplantation is considered an indicator of therapeutic success, which is increasingly important to measure by the transplant care team.
Individuals who undergo transplantation and their families often perceive transplantation as a rebirth. However, 30% to 40% of patients report no better health-related quality of life after kidney transplantation compared to dialysis. This is attributed to frequent checkups and monitoring, new medications and their strict dosing schedules, and the unexpected discomfort of potential side effects.
Even after the psychological challenges of waiting and the joy of a successful transplant, transplant recipients take on new responsibilities. Problems such as accepting transplantation risks, acute and chronic organ rejection, and adherence to lifelong medication regimens can arise. Persistent side effects of various immunosuppressive agents, adaptation and maintenance of the new organ, and uncertainty about the future due to rejection of transplanted organs and the subsequent re-transplantation process can all lead to physical and psychological distress.
Immunosuppressive therapy represents a lifelong endeavor for transplant recipients. These medication regimens involve complex protocols, not only due to the number of pills required, but also due to blood level monitoring, side effects, and frequent dose adjustments to avoid rejection. Non-adherence to immunosuppressant regimens has been shown to be high in organ transplant patients. Non-adherence rates in this population are reported as high as 65%. The highest immunosuppressant non-adherence rate is found in kidney transplant recipients, with a prevalence of 36-55%, while this rate is 15-40% in liver transplant recipients. Studies have found that 16-36% of graft losses are associated with non-adherence. The ever-growing population of transplant recipients and the limited number of transplant centers, particularly those living farther away, necessitate innovative healthcare delivery models to monitor and improve the use of transplant center resources. With the advent of smartphones and mobile medical devices, mobile health has become a popular way for healthcare professionals to manage patient care. Mobile health can serve as an adjunct method for delivering health education information, sending reminders to patients to take their medications, and implementing online education. In particular, converting paper-based education to video format can significantly increase knowledge on various topics. It is necessary to address the problems and challenges patients face after discharge and the practices that can potentially address these issues. These results suggest that healthcare professionals can do more to provide comprehensive care to patients, promote successful home-based treatment regimens, symptom control, and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobile applications | Experimental | Other: Mobile application installation |
| Teaching booklet | Experimental | Other: Providing teaching booklets |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years of age,
- Having undergone a liver or kidney transplant for the first time,
- Having been discharged at least three months ago,
- Having access to a smartphone and internet and the ability to use them independently,
Key exclusion criteria (3 listed)
- Having a diagnosis of a psychiatric or neurological disorder,
- Having hearing or vision problems severe enough to impede communication,
- Requesting to leave during the research period
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 |
|---|---|---|
| Mobile application installationTransplant patients will receive standard discharge training. A mobile application created by the researcher will be installed on transplant patients' phones. | Other | Mobile applications |
| Providing teaching bookletsTransplant patients will receive standard discharge training. Transplant patients will be given researcher prepared instructional booklet | Other | Teaching booklet |
| ControlTransplant patients will receive standard discharge training | Other | Control |
Primary outcome
The effect of education on quality of life in organ transplant patients
Time frame: Baseline, and 1, 3, and 6 months post-intervention.
The SF-36 Quality of Life Scale will be administered before the training intervention. Most questions on the scale use Likert-type rating scales (3, 5, and 6 points), while questions four and five can be answered with yes/no. Each section of the scale is rated between 0 and 100 points. Higher scores indicate better health, or improved quality of life ("0" for poor health, "100" for good health).
The effect of education on symptom control in organ transplant patients
Time frame: Baseline, and 1, 3, and 6 months post-intervention.
The Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 will be administered before the training intervention. Each item on the scale corresponds to a side effect of immunosuppressive drugs, and these items have two dimensions that assess symptom occurrence and discomfort level. Symptom occurrence is scored from 1 to 5, with 1=never occurring and 5=always occurring. Symptom discomfort level is scored from 0 to 4, with 0=never causing discomfort and 4=causing extreme discomfort.
The effect of education on adherence to ımmunosuppressive therapy in organ transplant patients
Time frame: Baseline, and 1, 3, and 6 months post-intervention.
The Immunosuppressant Therapy Adherence Scale in Organ Transplantation Patients will be administered before the training intervention. The scale consists of four questions, and participants can receive a score between 0 and 12. Individuals who have not forgotten their immunosuppressive treatment in the last three months are given 3 points, those with 1-20% non-adherence to immunosuppressive treatment are given 2 points, those with 21-50% non-adherence to immunosuppressive treatment are given 1 point, and those with >50% non-adherence to immunosuppressive treatment are given 0 points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application installation and Providing teaching booklets in people with Organ Transplantation and Mobile Applications, run by Ondokuz Mayıs 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rıfat GÜRKAN, Master of Science in Nursing (+905067154895, rifatgurkannn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of education on quality of life in organ transplant patients (time frame: Baseline, and 1, 3, and 6 months post-intervention.). 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 21 Oct 2026.