Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT07288918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Education on Quality of Life, Adherence to Immunosuppressive Therapy and Symptom Control in Organ Transplant Patients
Sponsor:
Ondokuz Mayıs University
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 (Grinyo, 2013). 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 (Yang et al., 2020).
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 (Girgenti et al., 2020). 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 (Burra and Germani, 2013).
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 (Villeneuve et al., 2021).
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 (Schulz and Kroencke, 2015).
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 (Shi et al., 2020). 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% (Nerini et al., 2016). The highest immunosuppressant non-adherence rate is found in kidney transplant recipients, with a prevalence of 36-55% (Gokoel et al., 2020), while this rate is 15-40% in liver transplant recipients (Zhang et al., 2019). Studies have found that 16-36% of graft losses are associated with non-adherence (Schmid et al., 2017). 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 (Concepcion and Forbes, 2020). With the advent of smartphones and mobile medical devices, mobile health has become a popular way for healthcare professionals to manage patient care (Ganjali et al., 2019). 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 (Ganjali et al., 2019). In particular, converting paper-based education to video format can significantly increase knowledge on various topics (Fleming et al., 2017). 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.
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 (Girgenti et al., 2020). 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 (Burra and Germani, 2013).
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 (Villeneuve et al., 2021).
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 (Schulz and Kroencke, 2015).
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 (Shi et al., 2020). 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% (Nerini et al., 2016). The highest immunosuppressant non-adherence rate is found in kidney transplant recipients, with a prevalence of 36-55% (Gokoel et al., 2020), while this rate is 15-40% in liver transplant recipients (Zhang et al., 2019). Studies have found that 16-36% of graft losses are associated with non-adherence (Schmid et al., 2017). 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 (Concepcion and Forbes, 2020). With the advent of smartphones and mobile medical devices, mobile health has become a popular way for healthcare professionals to manage patient care (Ganjali et al., 2019). 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 (Ganjali et al., 2019). In particular, converting paper-based education to video format can significantly increase knowledge on various topics (Fleming et al., 2017). 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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: