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NCT Number: NCT07447388

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Care bundle adherence

    Time frame: 6 month

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bilge Uğraş, PhD Candidate

CONTACT

[email protected]

+90534 238 66 09

Zeliha Özdemir Köken

CONTACT

[email protected]

+90505 586 63 46

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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