Not yet recruiting NCT07447388

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

No phase Interventional Transplant Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Identification of the Problem and Development of the Care Bundle.
Who it may be relevant to: Registry conditions: Transplant Patients. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

Care bundle adherence [Time frame: 6 month]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07447388 · HU-B-OTX-25001

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗