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IRCT20150706023084N9 IRCT 2021-07-21 Islamic Azad University, Pharmaceutical Sciences Branch Evaluation of Pharmacist Intervention for improving Adherence of Immunosuppressive Regimen in Kidney Transplant Recipients Evaluation of Pharmacist Intervention for Improving Adherence of Immunosuppressive Regimen includes Calcineurin Inhibitors and Measuring Blood Levels of the Immunosuppressive Agents in Kidney Transplant Recipients 2021-07-01 anticipated 50 Complete https://irct.ir/trial/46027 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization Method: Blocked ‎Randomization Randomization Tool: Sealed envelope The allocation of individuals to the intervention or control groups will be carried out randomly، as it contains two forms with code A and two forms with code B، where each patient will be studied either with code A or code B in one of the groups. N/A Kidney Transplant. Intervention 1: Intervention group:It consists of 25 people, each of whom, in addition to receiving a guidebook, includes all educational, behavioral and reinforcement actions and routine clinical appointments, benefits from the advice and support of a pharmacist. All interventions will be performed at a single center and the intervention in this group includes consultation and visit with a pharmacist to improve the patient's adherence to Immunosuppressive treatment regimen.These appointments will take place at least three years after the patient's transplant and at two-month intervals, and each patient will attend at least two appointments. In these appointments, the necessary advice is provided according to the patient's characteristics.At the appointments, measures such as taking the patient's medical history, completing the Morisky questionnaire, taking medication according to the doctor's instructions, socio-economic and Educational evaluation of the patient, measuring the patient's blood level of the drugs, identifying patient concerns about the drugs and answering patient questions, identification Possible causes of non adherence and efforts to resolve them, review the treatment regimen and the number of drugs required by the patient during this period will be done with the patient. Intervention 2: Control group: It consists of 25 people, each of whom receives only a handbook including all educational, behavioral and reinforcement measures and clinical routine appointments. These appointments will take place at least three years after the patient's transplant and at two month intervals. During the appointments, there is no consultation or visit with the pharmacist to improve the patient's adherence to the Immunosuppressive treatment regimen, and individuals do not receive any intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Rokhshad Gharehcheloo
Unit 5, No. 455, East Anooshiravan St., Mehrvila
Karaj Iran (Islamic Republic of) 3136964648 +98 26 3274 4461 Rokhshad_gh@yahoo.com Islamic Azad University scientific Maryam Shiehmorteza
2. No. 199, Yasaman Alley, Yakhchal St., Gholhak, Dr. Shariati St., Pharmaceutical Sciences Branch, Islamic Azad University, Tehran
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0051 Shiehmorteza@iaups.ac.ir 8. Pharmaceutical Sciences Branch, Islamic Azad University Iran (Islamic Republic of) Conscious satisfaction of the patient to participate in the study Age between 18 to 60 years Patients with kidney disease confirmed by doctors, kidney transplant have been done and at least 3 years have passed since their transplant Consumption of Immunosuppressive drug 18 years 60 years Both Reluctance to continue participating in the study Drug abuse Drug allergy Infection Z94.0 Kidney transplant status Behavior N/A Intervention group:It consists of 25 people, each of whom, in addition to receiving a guidebook, includes all educational, behavioral and reinforcement actions and routine clinical appointments, benefits from the advice and support of a pharmacist. All interventions will be performed at a single center and the intervention in this group includes consultation and visit with a pharmacist to improve the patient's adherence to Immunosuppressive treatment regimen.These appointments will take place at least three years after the patient's transplant and at two-month intervals, and each patient will attend at least two appointments. In these appointments, the necessary advice is provided according to the patient's characteristics.At the appointments, measures such as taking the patient's medical history, completing the Morisky questionnaire, taking medication according to the doctor's instructions, socio-economic and Educational evaluation of the patient, measuring the patient's blood level of the drugs, identifying patient concerns about the drugs and answering patient questions, identification Possible causes of non adherence and efforts to resolve them, review the treatment regimen and the number of drugs required by the patient during this period will be done with the patient. Control group: It consists of 25 people, each of whom receives only a handbook including all educational, behavioral and reinforcement measures and clinical routine appointments. These appointments will take place at least three years after the patient's transplant and at two month intervals. During the appointments, there is no consultation or visit with the pharmacist to improve the patient's adherence to the Immunosuppressive treatment regimen, and individuals do not receive any intervention. Adherence score in the Morisky Questionnaire. Timepoint: Measurement of adherence scores in the Morisky Questionnaire before the intervention and then in meetings at intervals of 2 months. Method of measurement: The 8-item Morisky Medication Adherence Scale (MMAS-8). Blood levels of Immunosuppressive drugs. Timepoint: Measurement of blood levels of Immunosuppressive drugs before the intervention and then at appointments at intervals of 2 months. Method of measurement: Blood test. Intra-Patient Variability (IPV) of Immunosuppressive drugs. Timepoint: Measurement of Intra-Patient Variability (IPV) of Immunosuppressive drugs before the intervention and then at appointments at intervals of 2 months. Method of measurement: Percent of Mean Absolute Deviation (MAD) formula. Pharmaceutical Sciences Branch, Islamic Azad University Approved 2020-07-05 Ethics Committee of Pharmaceutical Sciences Branch of Tehran Islamic Azad University of Medical Scie 2. No. 199, Yasaman Alley, Yakhchal St., Gholhak, Dr. Shariati St., Pharmaceutical Sciences Branch, Islamic Azad University, Tehran Tehran Tehran Iran (Islamic Republic of)