Effect of education versus no education on patients' beliefs about medications and their compliance in using them in patients with hyperlipidemia: a double blind randomized clinical trial
Objectives: To assess the education versus no education on patients' beliefs about medications and their compliance in using them in patients with hyperlipidemia.
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible patients with hyperlipidemia who will refer to Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) age of 18 to 80 years; (b) having hyperlipidemia; (c) indication for statin.
Exclusion criteria: (a) using other anti-hyperlipidemia agents simultaneously; (b) history of psychological disorders; (c) history of sensitivity to statin.
Intervention group: Routine treatment plus one hour face to face consultation with patients by pharmacologist.
Control group: Only routine treatment.
Primary outcome: Assessing the patient's compliance about drug instructions using Morisky's questionnaire before and 6 weeks after education.
Secondary outcome: Assessing the patient's belief about drug instructions using BMQ questionnaire before and 6 weeks after education
Randomization: Random assignment of the patients to the intervention and control groups one at a time.
Blinding: The interviewer who will fill out the questionnaires will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604119014N95
Registration date:2016-04-21, 1395/02/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-21, 1395/02/02
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-04-10, 1395/01/22
Expected recruitment end date
2017-02-22, 1395/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education versus no education on patients' beliefs about medications and their compliance in using them in patients with hyperlipidemia: a double blind randomized clinical trial
Public title
Effect of education versus no education on patients' beliefs about medications and their compliance in using them in patients with hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 18 to 80 years; (b) having hyperlipidemia; (c) indication for statin.
Exclusion criteria: (a) using other anti-hyperlipidemia agents simultaneously; (b) history of psychological disorders; (c) history of sensitivity to statin.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups one at a time.
Blinding: The interviewer who will fill out the questionnaires will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
IR.UMSHA.REC.1395.11
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
Assessing the patient's compliance about drug instructions
Timepoint
before and 6 weeks after education
Method of measurement
using Morisky's questionnaire
Secondary outcomes
1
Description
Assessing the patient's belief about drug instructions
Timepoint
before and 6 weeks after education
Method of measurement
using BMQ questionnaire
Intervention groups
1
Description
Routine treatment plus one hour face to face consultation with patients by pharmacologist
Category
Other
2
Description
Only routine treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mitra Kalvandi
Street address
Farshchian Hospital, Shahid Fahmideh Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Pharmacology, Hamadan University of Medical Sciences
Full name of responsible person
Mitra Kalvandi
Position
Pharmacology Student
Other areas of specialty/work
Street address
School of Pharmacology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3388 0572
Fax
Email
dr.MitraKalvandi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Maryam Mehrpooya
Position
Pharmacologist
Other areas of specialty/work
Street address
School of Pharmacology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3388 0572
Fax
Email
m_mehrpooya2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)