Protocol summary

Study aim
Determination of the effect of two types of short message service (interactive and non-interactive) on adherence to treatment in patients with hypertension
Design
A single blinded, randomized, controlled clinical trial with a parallel group
Settings and conduct
The present study was conducted on patients referred to AJA 502 hospital in Tehran, Iran for a period of four months in 2019. 63 patients were selected by purposive sampling method and then were randomly allocated to three groups of 21 patients Interactive Short Message Service (ISMS), Non-interactive Short Message Service (N-ISMS) and control. Questionnaires were completed for their patients and their blood pressure was measured in the first week of each month and in three separate days for all three groups. Four educational messages about adherence to the treatment of hypertension were sent to the ISMS and N-ISMS groups every week for a period of four months, a total of 64 messages. Additionally, in the ISMS group, patients without a time limit and within 24 hours, had two-way communication by asking their questions to the researcher. Questionnaires were completed again by the researcher four months after the beginning of the study.
Participants/Inclusion and exclusion criteria
The inclusion criteria: a clinical diagnosis of hypertension, aged 35-64 years, own or have daily access to a cellphone, lack of other diseases requires taking drugs other than anti-hypertensive drugs, not having a history of known heart disease, such as myocardial infarction, and willing to give informed consent to participate in the study. The exclusion criteria: unwillingness to participate further
Intervention groups
The intervention group 1 received interactive SMS, intervention group 2 non-interactive SMS intervention and control groups received a training booklet.
Main outcome variables
Adherence to treatment, Blood presssure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190120042423N1
Registration date: 2019-04-26, 1398/02/06
Registration timing: retrospective

Last update: 2019-04-26, 1398/02/06
Update count: 0
Registration date
2019-04-26, 1398/02/06
Registrant information
Name
Ehsan Rahmanipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7750 0404
Email address
ehsanrahmanipoor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-12-06, 1396/09/15
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
2018-09-23, 1397/07/01
Scientific title
Comparison of the effect of two types of interactive and non-interactive short message service on adherence to treatment in patients with hypertension
Public title
The effect of two types of interactive and non-interactive short message service on adherence to treatment in patients with hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A clinical diagnosis of hypertension and either currently receiving antihypertensive medication for at least a one month A systolic blood pressure 140-220 mmHg and a diastolic blood pressure 90-120 mmHg at enrolment. Aged 35-64 years Own or have daily access to a cellphone with able to send a SMS text-message Able to use the text messaging function (reading and composing a text message) Able to send and receive a SMS text-message Do not live in a household where another member has been recruited into the trial Currently residing in the trial area and expecting to be resident for the duration of the trial Lack of other diseases requires taking drugs other than anti-hypertensive drugs, such as diabetes Lack of use complementary therapies such as taking herbal medicines during the study Not having a history of known heart disease, such as myocardial infarction Lack of dementia, impaired short-term memory, mental and psychological problems, end-stage liver or kidney disease and cancer Willing to participate in the study
Exclusion criteria:
Patients whose regimen has changed for two months or more according to the physician's order Unwillingness to continue cooperation Pregnancy or lactation during the test for female participants
Age
From 35 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 63
Actual sample size reached: 63
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization Randomization unit: Individual Randomization tools: Throw the dice
Blinding (investigator's opinion)
Single blinded
Blinding description
The single-blind, clinical trial: Blindness was done at the level of the statistical analyst.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Of AJA University Of Medical Science
Street address
AJA University Of Medical Science, Etemadzade St., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2017-12-25, 1396/10/04
Ethics committee reference number
IR.AJAUMS.REC.1396.90

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I10-I15
ICD-10 code description
Hypertensive diseases

Primary outcomes

1

Description
Adherence to treatment
Timepoint
Start of study and 4 months after intervention.
Method of measurement
Treatment adherence questionnaire for patients with hypertension (TAQPH)

2

Description
Blood Pressure
Timepoint
Start of study and 1, 2, 3 and 4 months after intervention.
Method of measurement
Beurer GmbH, Söflinger Str. 218, 89077 Ulm, Germany, Type: BM16, Item No: 652.02

Secondary outcomes

empty

Intervention groups

1

Description
Interactive SMS group: For this group of patients, four training messages were sent each week for 4 months. During this period, patients had two-way communication by asking their questions to the researcher.
Category
Other

2

Description
Non-interactive SMS group: For this group of patients, four training messages were sent each week for 4 months.
Category
Other

3

Description
Control group: All patients in this group received a training package.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
502 AJA hospital
Full name of responsible person
ِDr. Behzad Moradi
Street address
502 AJA hospital, Bahar St., Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1571755511
Phone
+98 21 8882 8001
Fax
+98 21 8830 8109
Email
Ehsanrahmanipoor@Gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Armin Rezaeian
Street address
AJA University Of Medical Science, Etemadzade St., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
Fax
Email
Ehsanrahmanipoor@Gmail.com
Web page address
http://www.ajaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Ehsan Rahmanipour
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 33, Qhomi Nejad, Mohammadi St., Jashnvare Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1654854791
Phone
+98 912 804 3182
Email
Ehsanrahmanipoor@Gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Shahla Aliari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
College of AJA Nursing, Kaj St., Dr Shariati Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۶۱۵۱۱۶۱۳۹
Phone
+98 21 7750 0929
Fax
+98 21 7760 1533
Email
Sh.aliyari@ajaum.ac.ir
Web page address
http://nursing.ajaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ehsan Rahmanipour
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 33, Qhomi Nejad, Mohammadi St., Jashnvare Ave.,Tehran
City
Tehran
Province
Tehran
Postal code
1654854791
Phone
+98 912 804 3182
Email
Ehsanrahmanipoor@Gmail.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
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