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
Determining the Effect of Pharmacist Intervention on the Rate of Adherence to Immunosuppression Regimens and Measuring the Level of Drug in Kidney Transplant Patients
Design
Clinical trial with control group, randomized, phase not applicable on 50 patients. Sealed envelope is used for randomization
Settings and conduct
This study was performed on 50 transplant patients in Labbafinejad Hospital. Our choice is in randomized way and the study was randomly controlled, with and without intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient informed consent, age between 18 and 60 years, patients who have been transplanted for at least 3 years, taking immunosuppressive drugs; Exclusion criteria: unwillingness to continue studying, substance abuse, drug sensitivity, infection
Intervention groups
Intervention group: getting a manual along with consultation and visit of a pharmacist; Control group: Just get the manual
Main outcome variables
Adherence score in Morisky questionnaire, blood level of immunosuppressant drugs, fluctuation of blood concentrations in a certain period of time (IPV) of immunosuppressant drugs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023084N9
Registration date:2021-07-21, 1400/04/30
Registration timing:registered_while_recruiting
Last update:2021-07-21, 1400/04/30
Update count:0
Registration date
2021-07-21, 1400/04/30
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of Pharmacist Intervention for improving Adherence of Immunosuppressive Regimen in Kidney Transplant Recipients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Reluctance to continue participating in the study
Drug abuse
Drug allergy
Infection
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Pharmaceutical Sciences Branch of Tehran Islamic Azad University of Medical Scie
Street address
2. No. 199, Yasaman Alley, Yakhchal St., Gholhak, Dr. Shariati St., Pharmaceutical Sciences Branch, Islamic Azad University, Tehran
City
Tehran
Province
Tehran
Postal code
193956466
Approval date
2020-07-05, 1399/04/15
Ethics committee reference number
IR.IAU.PS.REC.1399.105
Health conditions studied
1
Description of health condition studied
Kidney Transplant
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
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)
2
Description
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
3
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinezhad Hospital
Full name of responsible person
Shiva Samavat
Street address
9th Boostan St, Pasdaran St, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 23601
Fax
+98 21 2254 9039
Email
Labafinejad.hos@tamin.ir
Web page address
http://labafinejad.tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Dr. Farshad Hashemian
Street address
4. No. 3, Khaghani St., Shariati St., Islamic Azad University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
+98 21 2260 0714
Email
info@iau.ac.ir
Web page address
http://iaups.iautmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Pharmaceutical Sciences Branch, Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rokhshad Gharehcheloo
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 5, No. 455, East Anooshiravan St., Mehrvila
City
Karaj
Province
Alborz
Postal code
3136964648
Phone
+98 26 3274 4461
Email
Rokhshad_gh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
8. Pharmaceutical Sciences Branch, Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
PhD in Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
2. No. 199, Yasaman Alley, Yakhchal St., Gholhak, Dr. Shariati St., Pharmaceutical Sciences Branch, Islamic Azad University, Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
Shiehmorteza@iaups.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rokhshad Gharehcheloo
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 5, No. 455, East Anooshiravan St., Mehrvila
City
Karaj
Province
Alborz
Postal code
3136964648
Phone
+98 26 3274 4461
Email
Rokhshad_gh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available