Transplant PatientsNCT07447388
Development, Pilot Testing and Evaluation of the Effectiveness of Immunosuppressive Medication Adherence Care Bundle in Patients Undergoing Solid Organ Transplantation
A study testing Identification of the Problem and Development of the Care Bundle in people with Transplant Patients, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Patients
- What is being tested?
- Identification of the Problem and Development of the Care Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being followed up in the intensive care unit due to complications or other reasons
- Unwillingness to continue participating in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Identification of the Problem and Development of the Care Bundle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of the Problem and Development of the Care BundleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Testing of the Care Bundle, Evaluation of the Effectiveness of the Care Bundle | Other | Not described Receives: Other: Identification of the Problem and Development of the Care Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant PatientsStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Ugras, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447388
- Sponsor's protocol ID
- HU-B-OTX-25001
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Pilot Testing and Evaluation of the Effectiveness of Immunosuppressive Medication Adherence Care Bundle in Patients Undergoing Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT07447388
- Acronym / sponsor ID
- HU-B-OTX-25001
- Conditions
- Transplant Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Being followed up in the intensive care unit due to complications or other reasons
- Unwillingness to continue participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of the Problem and Development of the Care BundleThere 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. | Other | Pilot Testing of the Care Bundle, Evaluation of the Effectiveness of the Care Bundle |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Identification of the Problem and Development of the Care Bundle in people with Transplant Patients, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bilge Uğraş, PhD Candidate (+90534 238 66 09, bilge.ugras.14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care bundle adherence (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.