Protocol summary

Summary
Objectives: This study aims to compare the effectiveness of short message service (SMS) to reminder cards with regard to medication adherence in patients with hypertension. Design: The present study is a randomized controlled clinical trial. Major inclusion and exclusion criteria: Uncontrolled hypertension confirmed by doctor; being on medication for hypertension; living in the city of Urmia; having access to a mobile phone in patient or a member of his family; being able to use the text messaging function in patient or a member of his family (reading and composing a text message); not being on medication for prostate in the male patients; and willingness to participate in the study will be entry requirements. The exclusion criteria will be: being hospitalized in the duration of the study, unwillingness to participate further; moving to another city; and loss of contact with the patient through his/her mobile phone. Setting and conduct: The subjects consisted of 123 of the patients with hypertension at the clinical-educational center of Sayyed-Al Shohada, Urmia, who met the study criteria. Will select based on the convenience method, the samples will be randomly divided into three groups: the SMS group, the reminder-cards group, and the control group. Intervention: The subjects in the SMS group will sent 6 text messages a week for three months, and the subjects in the reminder-cards group will train in how and in what order to use their cards. Outcome measures: Adherence to treatment

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110917059N2
Registration date: 2015-12-13, 1394/09/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-13, 1394/09/22
Registrant information
Name
Masoume Hemmati Maslakpak
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1365 9031
Email address
hemmati_m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Urmia University of Medical Sciences
Expected recruitment start date
2014-03-03, 1392/12/12
Expected recruitment end date
2014-07-03, 1393/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effectiveness of short message service and reminder cards regarding medication adherence in patients with hypertension: A randomized controlled clinical trial
Public title
SMS and reminder cards for improving medication adherence
Purpose
Health service research
Inclusion/Exclusion criteria
Major inclusion and exclusion criteria: Uncontrolled hypertension confirmed by doctor; being on medication for hypertension; living in the city of Urmia; having access to a mobile phone in patient or a member of his family; being able to use the text messaging function in patient or a member of his family (reading and composing a text message); not being on medication for prostate in the male patients; and willingness to participate in the study will be entry requirements. The exclusion criteria will be: being hospitalized in the duration of the study, unwillingness to participate further; moving to another city; and loss of contact with the patient through his/her mobile phone.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 143
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using colored bags

Secondary Ids

1

Registry name
no
Secondary trial Id
no
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urmia Medical University
Street address
Urmia, Seru Road. Pardis Nazlu
City
Urmia
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
192

Health conditions studied

1

Description of health condition studied
hypertension
ICD-10 code
I10, I15
ICD-10 code description
Essential (primary) hypertension, Secondary hypertension

Primary outcomes

1

Description
Adherence to treatment
Timepoint
Two times
Method of measurement
Hill-Bone medication adherence scale

Secondary outcomes

1

Description
Hypertension
Timepoint
Two times
Method of measurement
Mercury sphygmomanometer

Intervention groups

1

Description
Intervention group 1: In the reminder cards group, cards in four different colors with the content of the medication regimen (30 cards), diet (30 cards), physical activities (30 cards) and blood pressure monitoring (30 cards) will be designed. Patients will be educated about how to properly use the card (every day of every educational content 1 card). So that the end of the first month 120 card will be read by patients , and in the second and third month reading cards will be repeated two more times. The patients will be expected to inform the researchers if they failed to check their blood pressure or have to visit the clinical center again in the duration of the intervention. Also, all the patients will be asked to visit the clinical center on alternate weeks (6 times in total during the 3-month intervention) and have their blood pressure checked for free.
Category
Treatment - Drugs

2

Description
Intervention group 2: The patients in the text messaging group will be sent 6 messages a week. Educational content of text messaging is same to educational content of reminder cards and contains medication regimen, diet, physical activities and blood pressure monitoring. Send messages will continue for 3 months. The patients will be expected to inform the researchers if they failed to check their blood pressure or have to visit the clinical center again in the duration of the intervention. Also, all the patients will be asked to visit the clinical center on alternate weeks (6 times in total during the 3-month intervention) and have their blood pressure checked for free.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinical-Educational Center of Sayyed-Al Shohada
Full name of responsible person
Iraj Mohebi
Street address
Postal Code: 571478334, Orjhans Street, Resalat Blvd, Urmia
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Iraj Mohebi
Street address
Postal Code: 571478334, Orjhans Street, Resalat Blvd, Urmia
City
Urmia
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, Urmia 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia Medical University
Full name of responsible person
Masumeh Hemmati Maslakpak
Position
Ph.D
Other areas of specialty/work
Street address
Postal Code: 571478334, Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Postal code
Phone
+98 44 3365 9031
Fax
Email
hemmatma@yahoo.com
Web page address

Person responsible for updating data

Contact

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
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