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OpenTrials
Completed

NCT Number: NCT04715412

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

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

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Key information

Conditions

Transplant;Failure,Kidney

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Transplantation Clinic Nasser Institute

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

patient counseling and adherence support

Other

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 outcomes

  1. 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

Secondary outcomes

  1. Renal function

    Time frame: 6 months

    Serum creatinine mg/dL

  2. Renal function

    Time frame: 6 months

    BUN (blood urea nitrogen) mg/dL

  3. Renal function

    Time frame: 6 months

    Serum uric acid mg/dL Serum uric acid

  4. Serum trough Immunosuppressant level (C0)

    Time frame: 6 months

    Serum level of immunosuppressant

  5. CBC

    Time frame: 6 months

    blood sample to asses (RBCs, WBCs and platelets)

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Collaborators

  • Ain Shams University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 20, 2021
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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