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

January 16, 2021 updated by: Doaa Mohamed Salah ElDin Diab ELBohy, Future University in Egypt

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Transplantation Clinic Nasser Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Study group

The 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specified clinical and educational outcome
Time Frame: 6 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function
Time Frame: 6 months
Serum creatinine mg/dL
6 months
Renal function
Time Frame: 6 months
BUN (blood urea nitrogen) mg/dL
6 months
Renal function
Time Frame: 6 months
Serum uric acid mg/dL Serum uric acid
6 months
Serum trough Immunosuppressant level (C0)
Time Frame: 6 months
Serum level of immunosuppressant
6 months
CBC
Time Frame: 6 months
blood sample to asses (RBCs, WBCs and platelets)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Collaborators

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 10, 2020

Primary Completion (ACTUAL)

November 11, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 16, 2021

First Posted (ACTUAL)

January 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-ASU No 10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe