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

Primary Purpose

Transplant;Failure,Kidney

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
patient counseling and adherence support
Sponsored by
Future University in Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Transplant;Failure,Kidney

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Transplantation Clinic Nasser Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Renal function
Serum creatinine mg/dL
Renal function
BUN (blood urea nitrogen) mg/dL
Renal function
Serum uric acid mg/dL Serum uric acid
Serum trough Immunosuppressant level (C0)
Serum level of immunosuppressant
CBC
blood sample to asses (RBCs, WBCs and platelets)

Full Information

First Posted
January 14, 2021
Last Updated
January 16, 2021
Sponsor
Future University in Egypt
Collaborators
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04715412
Brief Title
Clinical Pharmacy Guided Patient Counselling and Adherence Support on Renal Transplant Recipients
Official Title
Impact of Clinical Pharmacy Guided Patient Counseling and Adherence Support on Renal Transplant Recipients' Adherence and Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
November 11, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt
Collaborators
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplant;Failure,Kidney

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
patient counseling and adherence support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Specified clinical and educational outcome
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Renal function
Description
Serum creatinine mg/dL
Time Frame
6 months
Title
Renal function
Description
BUN (blood urea nitrogen) mg/dL
Time Frame
6 months
Title
Renal function
Description
Serum uric acid mg/dL Serum uric acid
Time Frame
6 months
Title
Serum trough Immunosuppressant level (C0)
Description
Serum level of immunosuppressant
Time Frame
6 months
Title
CBC
Description
blood sample to asses (RBCs, WBCs and platelets)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Transplantation Clinic Nasser Institute
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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