The Effect of Education on Quality of Life, Adherence to Immunosuppressive Therapy and Symptom Control in Organ Transplant Patients

NCT ID: NCT07288918

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2026-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Organ Transplantation Mobile Applications Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mobile applications

Group Type EXPERIMENTAL

Mobile application installation

Intervention Type OTHER

Transplant patients will receive standard discharge training. A mobile application created by the researcher will be installed on transplant patients' phones.

Teaching booklet

Group Type EXPERIMENTAL

Providing teaching booklets

Intervention Type OTHER

Transplant patients will receive standard discharge training. Transplant patients will be given researcher prepared instructional booklet

Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Transplant patients will receive standard discharge training

Interventions

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Mobile application installation

Transplant patients will receive standard discharge training. A mobile application created by the researcher will be installed on transplant patients' phones.

Intervention Type OTHER

Providing teaching booklets

Transplant patients will receive standard discharge training. Transplant patients will be given researcher prepared instructional booklet

Intervention Type OTHER

Control

Transplant patients will receive standard discharge training

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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,

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Rıfat GÜRKAN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ondokuz Mayis University

Samsun, Samsun, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Rıfat GÜRKAN, Master of Science in Nursing

Role: CONTACT

Phone: +905067154895

Email: [email protected]

Other Identifiers

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OMU-GURKAN-001

Identifier Type: -

Identifier Source: org_study_id