Study of the effect of Short Message Service (SMS) and pamphlet on adherence to anti- hypertensives drugs in patients of to Emam-Reza Heart Clinic, Shiraz, Iran
Comparison of the effect of SMS and pamphlet on adherence to anti-hypertensive medications in patients of Emam-Reza Cardiac Clinic, Shiraz, Iran
Design
In this study, 282 patients with cardiovascular disease who are eligible to enter the study who are referred to the Imam Reza Clinic of Shiraz are selected. Participants are randomly assigned to three groups of pamphlets and control SMS, and each participant is assigned a code.
Settings and conduct
Researcher refers to Emam-Reza clinic in Shiraz and selects the samples randomly. Then, they will allocate to three groups: SMS, pamphlet, and control. Using Morisky's questionnaire, which has been validated for Iranian society, data are collected. Based on the data analysis, educational content and key messages will be developed and used for SMS and pamphlets preparation. One and three months later, the data will be collected again and compared to the before phase.
Participants/Inclusion and exclusion criteria
Criteria for entering the study
patients with cardiovasculardiseases who are taking anti-hypertensive medications
Having 9-graded literacy level
patients (or the family members) who have mobile phone that covers the persian language
Exit criteria:
Discontinuation of anti-hypertensive medications by the order of the physician
Not willing to cooperation with the study
Intervention groups
The Pamphlet group who receive content related to medication adherence.
The SMS group who receives SMS in their cell phone.
The control group who does not intervene on them.
Main outcome variables
Medication adherance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171227038098N1
Registration date:2018-02-17, 1396/11/28
Registration timing:retrospective
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Somaye Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 2862
Email address
somaye.zare@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-29, 1396/03/08
Expected recruitment end date
2017-06-29, 1396/04/08
Actual recruitment start date
2017-05-29, 1396/03/08
Actual recruitment end date
2017-06-29, 1396/04/08
Trial completion date
empty
Scientific title
Study of the effect of Short Message Service (SMS) and pamphlet on adherence to anti- hypertensives drugs in patients of to Emam-Reza Heart Clinic, Shiraz, Iran
Public title
Drug compliance in cardiovascular patients who are taking blood pressure medication
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Cardiovascular diseases who are taking anti-hypertensive medications
Having 9-graded literacy level
Patients (or the family members) who have mobile phone that covers the Persian Language fonts
Exclusion criteria:
Discontinuation of anti-hypertensive medications by the order of the physician
Not willing to cooperation with the study
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
282
Actual sample size reached:
282
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple random method and individual randomization unit, the random number table was a randomization tool
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 Yasuj University of Medical Sciences
Street address
Chancellor of Research, Yasuj University of Medical Sciences, Emam-Khomeini Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
71937-11351
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.YUMS.REC.1396.2
Health conditions studied
1
Description of health condition studied
Cardio-vascular disease
ICD-10 code
I11.9
ICD-10 code description
Hypertensive heart disease without heart failure
Primary outcomes
1
Description
medication adherance
Timepoint
"Measuring drug compliance at the beginning of the study (before the intervention) and one month and three months after the intervention
Method of measurement
Morischi questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group 1: Tailored pamphlet containing two subjects:reminder message for medication time and complication of medication to the patients and asked them instal that on the refrigerator before his/her eyes.The intervention will be implemented for one month,and one and three months later,the questionnaire will be completed by particepants."
Category
Behavior
2
Description
"Intervention group 2:Sending SMS through mobile phone to remind the patients about medication time and complication of medication.these messages will be sent three times a week,and at 10 AM and 5 PM daily.The intervention will be implemented for one month,and one and three months later,the questionnaire will be completed by particepants."
Category
Behavior
3
Description
"Control group: They are patients who recieved routine services by physiciens without any pamphelet and SMS"
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam-Reza Clinic of Shiraz
Full name of responsible person
Mohsen Shams
Street address
Chancellor of Research, Yasuj University of Medical Sciences, Emam-Khomeini Blvd.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
71937-11351
Phone
+98 71 3234 2862
Email
somaye.zare@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Chancellor of Research, Yasuj University of Medical Sciences
Street address
Chancellor of Research, Yasuj University of Medical Sciences, Emam-Khomeini Blvd.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
71937-11351
Phone
+98 71 3234 2862
Email
somaye.zare@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
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
Yasouj University of Medical Sciences
Full name of responsible person
Mohsen Shams
Position
Ph.D. Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Chancellor of Research, Yasuj University of Medical Sciences, Emam-Khomeini Blvd.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
71937-11351
Phone
+98 71 3234 2862
Email
moshaisf@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohsen Shams
Position
Ph.D. Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Chancellor of Research, Yasuj University of Medical Sciences, Emam-Khomeini Blvd.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
71937-11351
Phone
+98 71 3234 2862
Email
moshaisf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohsen Shams
Position
Ph.D. Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Chancellor of Research, Yasuj University of Medical Sciences, Emam-Khomeini Blvd.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
71937-11351
Phone
+98 71 3234 2862
Email
moshaisf@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
This study is a M.Sc. thesis and its final report will be present in University and internal databases. Additionally, the papers will be published in Farsi and English journals.
When the data will become available and for how long
Access to the report starts immediately after the viva, and access to papers starts immediately after the publication.
To whom data/document is available
Available to researchers working in academia and scientific organizations
Under which criteria data/document could be used
For using in similar researches , or writing review articles and systematic reviews