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

Transplant;Failure,Kidney Clinical Trial

Official title:

Impact of Clinical Pharmacy Guided Patient Counseling and Adherence Support on Renal Transplant Recipients' Adherence and Health Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04715412
• Other study ID #: REC-ASU No 10
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Insufficiency
• Transplant;Failure,Kidney

Intervention

Other:
• patient counseling and adherence support
Technical interventions include; identification of possible reasons for non-adherence, adherence support by developing simplified schedules for taking medications that were customized to individualized patient's lifestyle. Reminders for dose as well as tools/strategies the RTR may use to follow the dosing schedules if needed as pillbox were provided as needed Clinical pharmacists' guided patient training was individualized, repetitive, covered 6 months, and included more aspects and provided practical hints and strategies for medication management. Initial clinical pharmacist face-to-face session will be up to 60-minute then 30-minute follow-up sessions will be conducted monthly for 6 months during the scheduled post-transplant clinic visits as coordinated with the transplant physician to allow for single office visits for transplant related issues and comorbidities.

Locations

Country	Name	City	State
Egypt	Transplantation Clinic Nasser Institute	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Future University in Egypt	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specified clinical and educational outcome	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	6 months
Secondary	Renal function	Serum creatinine mg/dL	6 months
Secondary	Renal function	BUN (blood urea nitrogen) mg/dL	6 months
Secondary	Renal function	Serum uric acid mg/dL Serum uric acid	6 months
Secondary	Serum trough Immunosuppressant level (C0)	Serum level of immunosuppressant	6 months
Secondary	CBC	blood sample to asses (RBCs, WBCs and platelets)	6 months