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Clinical Pharmacy Guided Patient Counselling and Adherence Support on Renal Transplant Recipients

Not Applicable
Completed
Conditions
Transplant;Failure,Kidney
Interventions
Other: patient counseling and adherence support
Registration Number
NCT04715412
Lead Sponsor
Future University in Egypt
Brief Summary

As a result of the shortage of donor organs and the close relationship between allograft or even life loss and non-adherence after kidney transplantation, improvement of patient adherence appears essential. So the current study aimed to monitor adherence barriers of renal transplant recipients and evaluate possible consequences of nonadherence on recipients' clinical outcomes as well as to implement a structured adherence management program consisting of intensified patient counselling and adherence support by a dedicated clinical pharmacist as an adjunct to standard post-transplant patient education carried out by transplant physicians to investigate the efficacy of the implemented program on patients adherence and health outcomes as compared to standard physician patient care. The study is a prospective self-controlled interventional study that recruited 69 living donors-renal transplant Patients attending the transplant clinic of Nasser institute and satisfying the inclusion criteria. On enrolment, patient-related baseline data that could determine and affect patients' adherence as well as patients' clinical outcomes were recorded. After all patients received the adjuvant adherence management program by the clinical pharmacist for 6 month, patients' health outcomes were re-evaluated to compare them to baseline data

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria

>18 years at least 1 year post-transplant to allow for stabilization of the prescribed immunosuppressant therapy (IST) regimen Independent of others for medication management and willing as well as able to repetitively visit the outpatient clinic for educational training & data collection.

Exclusion Criteria
  • Pediatric Older than 65 years. Multi-organ transplant. Pregnant or lactating. Cancer patients.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Study grouppatient counseling and adherence supportThe standard training sessions were conducted for individual patient by the transplant physician to explain rejections, infections and tumor risks, post-transplant medication. After discharge, all patients had scheduled follow-up visits at the outpatient clinic of the transplant center, where immune suppressant blood levels were measured and their dosing adjusted accordingly. Patients also had the opportunity to discuss any concern of their condition or drug therapy with the transplant physician in charge. in addition to this standard transplant training, patients received intensified care by a dedicated clinical pharmacist combining educational and technical interventions aiming at achieving and maintaining adherence to his/her prescribed medication and improving health outcomes.
Primary Outcome Measures
NameTimeMethod
Specified clinical and educational outcome6 months

Self-reported taking adherence \[TA, percentage of doses taken in comparison to the total number of doses prescribed\]. Patients will be classified as being adherent for those with TA ≥80 or non-adherent for those with TA \<80

Secondary Outcome Measures
NameTimeMethod
CBC6 months

blood sample to asses (RBCs, WBCs and platelets)

Renal function6 months

Serum uric acid mg/dL Serum uric acid

Serum trough Immunosuppressant level (C0)6 months

Serum level of immunosuppressant

Trial Locations

Locations (1)

Transplantation Clinic Nasser Institute

🇪🇬

Cairo, Egypt

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