Protocol summary

Summary
Improper use of antihypertensive drugs appears to be the major cause of treatment failure in blood pressure control. The purpose of this study is to evaluate the effect of short message reminder on medication adherence of patients with chronic hypertension. The population of this randomized clinical trial study includes patients with hypertension referred to Dr. Azeemzadeh Heart Clinic, Kerman, Iran for the treatment. Inclusion criteria are patients with at least 8 months history of hypertension (systolic pressure > 180mm/Hg and diastolic pressure> 110mmHg) and to possess a personal mobile phone. Exclusion criteria are taking other medications except antihypertensive drugs such as anti-diabetes drugs, use of complementary therapies such as herbal drugs, smoking and coronary disease or any other condition that is associated with high risk of stroke. Consent form is completed by patients and their mobile phone number is recorded. A total of 380 patients are randomly divided into the 2 groups. A daily message reminder will be sent to the intervention group to follow the medication adherence for a period of 6 months. The control group receives no message. In both groups, blood pressure is measured before the intervention and then monthly for 6 months. At the end of the study, changes in blood pressure in both groups are studied and analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013051313315N1
Registration date: 2013-12-26, 1392/10/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-26, 1392/10/05
Registrant information
Name
Roghayeh Ershad Sarabi
Name of organization / entity
School Of Health Management And Information Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 4302
Email address
re_ershad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Of Tehran University of Medical Sciences
Expected recruitment start date
2013-12-23, 1392/10/02
Expected recruitment end date
2014-04-22, 1393/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Of Effectiveness Of Short Text Message Reminders On Medication Adherence In Patients With Chronic Hypertention
Public title
Effectiveness Of Short Text Message Reminders On Medication Adherence In Patients With Chronic Hypertention
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 65 years; possessing at least one personal mobile phone; being literate; ability to send and receive massages with mobile phones; receiving only oral agents. Exclusion criteria: suffering from other diseases that require taking other medications except antihypertensive drugs such as diabetes; use of complementary therapies such as herbal drugs; smoking and coronary disease or any other condition that is associated with a high risk of stroke.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 380
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tehran University Of Medical Science
Street address
Dameshegh St. Palestine Ave., Keshavarz Blvd. Tehran- Iran
City
Tehran
Postal code
Approval date
2013-05-27, 1392/03/06
Ethics committee reference number
92/3/1301/د

Health conditions studied

1

Description of health condition studied
Hypertention
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Hypertention
Timepoint
start of study,1,2,3,4,5,6 months after intervention.
Method of measurement
mmHg by using arm digital blood pressure device

Secondary outcomes

1

Description
Hospitality
Timepoint
At end of study
Method of measurement
Patien interview

Intervention groups

1

Description
Patients in the intervention group will be receive daily SMS messages for Recalling the time of drug use for six monthes .
Category
Other

2

Description
Patients in the control group will be not receive any SMS messages and they will follow their usual care .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr.Azeemzadeh Heart Clinic
Full name of responsible person
Dr.Behzad Azeemzadeh
Street address
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Of Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Science , Qods St.,Enghelab St.
City
Tehran
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 Of Tehran 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
Tehran University of Medical Science/iran
Full name of responsible person
Roghayeh Ershad Sarabi
Position
phD student
Other areas of specialty/work
Street address
NO. 8, School of Health Management and Information Sciences, Shahid Yasemi Street, Valiasr Avenue, Vanak square, Tehran, Iran.
City
Tehran
Postal code
1995614111
Phone
+98 21 8879 4302
Fax
+98 21 8879 3805
Email
re_ershad@kmu.ac.ir,a.ershadsarabi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University Of Medical Science
Full name of responsible person
Farahnaz Sadoughi
Position
Associate Professor In Health Information Management
Other areas of specialty/work
Street address
NO. 8, School of Health Management and Information Sciences, Shahid Yasemi Street, Valiasr Avenue, Vanak square, Tehran, Iran
City
Tehran
Postal code
Iran
Phone
+98 21 8879 4302
Fax
+98 21 8879 3805
Email
sadoughi.f@gmail.com>
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University Of Medical Science
Full name of responsible person
Roghayeh Ershad Sarabi
Position
phD student
Other areas of specialty/work
Street address
NO. 8, School of Health Management and Information Sciences, Shahid Yasemi Street, Valiasr Avenue, Vanak square, Tehran, Iran
City
Tehran
Postal code
Iran
Phone
+98 34 1212 4983
Fax
+98 34 1320 5347
Email
re_ershad@kmu.ac.ir, a.ershadsarabi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...