Development, Pilot Testing and Evaluation of the Effectiveness of Immunosuppressive Medication Adherence Care Bundle in Patients Undergoing Solid Organ Transplantation

NCT07447388 | Not Yet Recruiting

• 1 other identifier: HU-B-OTX-25001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Organ transplantation is the gold standard treatment method that increases the quality and duration of life in patients with end-stage organ failure, and one of the most important complications after transplantation is graft rejection. Immunosuppressive therapy is critically important in preventing rejection and preserving graft function. Although non-adherence to immunosuppressive therapy is a risk factor for poor clinical outcomes after transplantation, it is often not well managed, and only a small proportion of interventions aimed at improving medication adherence can be translated into clinical practice. Therefore, there is a need to develop a care bundle that includes evidence-based practices to standardize interventions aimed at improving adherence to immunosuppressive medication use in organ transplant recipients, improve patient outcomes, and enhance the quality of care. This mixed-methods study is planned to develop and test an immunosuppressive medication adherence care bundle for solid organ transplant recipients using the Knowledge-to-Action (KTA) framework. The study will be conducted with patients who have undergone heart transplantation at the Heart Transplantation Clinic of Ankara Bilkent City Hospital Cardiovascular Hospital. Data will be collected using the "Patient Information Form," "Immunosuppressive Medication Adherence Care Bundle Checklist," "Care Bundle Adherence Evaluation Form," "Semi-structured Interview Form," and the "Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS©)." The study will be carried out in three phases: identification of the problem and development of the care bundle (Phase 1), pilot implementation (Phase 2), and effectiveness evaluation (Phase 3). Through this study, an evidence-based immunosuppressive medication adherence care bundle for solid organ transplant recipients will be introduced to the literature using the KTA framework. The developed care bundle is expected to standardize practices related to the management of adherence to immunosuppressive medications and promote the use of evidence-based practices in patient care in clinical settings.

Conditions

Transplant Patients

Outcome Measures

Primary Outcomes (1)

• Care bundle adherence

  Care package compliance will be evaluated at the end of the pilot implementation (at 6 months) by assessing heart transplant patients' adherence to immunosuppressive medication using the BAASIS© scale. The compliance rate with the care package parameters, calculated using the formula recommended by the Institute for Healthcare Improvement (IHI), will indicate the success of care package adherence. A calculated rate below 95% will be considered as unsuccessful adherence to the care package.

  6 month

Study Arms (1)

Pilot Testing of the Care Bundle, Evaluation of the Effectiveness of the Care Bundle

OTHER

Other: Identification of the Problem and Development of the Care Bundle

Interventions

Identification of the Problem and Development of the Care Bundle OTHER

There is a need to develop a care bundle that includes evidence-based practices to standardize interventions aimed at improving adherence to immunosuppressive medication use in organ transplant recipients, improve patient outcomes, and enhance the quality of care.

Pilot Testing of the Care Bundle, Evaluation of the Effectiveness of the Care Bundle

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
• Having no communication barriers
• Being literate
• Being able to speak and understand Turkish
• Having no diagnosed psychiatric disorder
• Meeting the discharge criteria from the clinic after organ transplantation

You may not qualify if:

• Being followed up in the intensive care unit due to complications or other reasons
• Unwillingness to continue participating in the study

Sponsors & Collaborators

• Hacettepe University: lead

Central Study Contacts

Bilge Uğraş, PhD Candidate

CONTACT

+90534 238 66 09; bilge.ugras.14@gmail.com

Zeliha Özdemir Köken

CONTACT

+90505 586 63 46; ozdemir.z@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 3, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share