Protocol summary

Summary
Objectives: The Effects of an educational intervention according the Health Belief Model on improving Care and Control among patients with Hypertension. Design: Randomized clinical trial. Participants including major eligibility criteria: Two hundred hypertensive patients (100 in intervention group and 100 in control group). The main criteria for inclusion: having primary hypertension without side effects of blood pressure, and intending to reside in the city of Bam during the next 5 months; Exclusion criteria: unwillingness to participate in the study. Sample size: 200 Intervention or interventions studied: Three 60-minute training sessions (once a month) as lecture, question and answer sessions, and practical demonstrations. Intervention: Before and 3 months after. intervention. main outcome measures (variables): Review the attitude and blood pressure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051817734N1
Registration date: 2014-07-13, 1393/04/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-13, 1393/04/22
Registrant information
Name
Reza Sadeghi
Name of organization / entity
Sirjan Health Department , Kerman University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 34 5422 4339
Email address
reza.sadeghi351@yahoo.com
Recruitment status
Recruitment complete
Funding source
Research Council of Kerman University of Medical Sciences
Expected recruitment start date
2013-05-10, 1392/02/20
Expected recruitment end date
2013-08-11, 1392/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of an educational intervention according the Health Belife Model on improving Care and Control among patients with Hypertension
Public title
Impact of educational intervention on control of blood pressure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included: having primary hypertension without side effects of blood pressure, and intending to reside in the city of Bam during the next 5 months; Exclusion criteria: unwillingness to participate in the study.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 200
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 Kerman University of Medical Sciences
Street address
Unit 12, No 38, Jahad St, Shariatee Ave, after Thamasb abad Cross, Kerman
City
Kerman
Postal code
۷۶۱۷۵۵۸۴
Approval date
2013-11-07, 1392/08/16
Ethics committee reference number
92/227

Health conditions studied

1

Description of health condition studied
hypertension
ICD-10 code
I10, I11,
ICD-10 code description
Hypertensive diseases

Primary outcomes

1

Description
Attitude
Timepoint
Before the intervention, and 3 months after intervention
Method of measurement
Standardized questionnaire

2

Description
Hypertension
Timepoint
Before the intervention, and 3 months after intervention
Method of measurement
Sphygmomanometer (mm/Hg)

Secondary outcomes

1

Description
Age
Timepoint
Before the intervention, and 3 months after intervention
Method of measurement
Year

2

Description
Family history of hypertension
Timepoint
Before and 3 months after intervention.
Method of measurement
questionnair

Intervention groups

1

Description
Intervention group: training during three 60-minute sessions (once a month) as lecture, question and answer, practical display.
Category
Prevention

2

Description
In the control group after completing the questionnaire at a later stage of the training group, the training group with the same quantity and quality offered
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers
Full name of responsible person
Technicians and workers
Street address
No 39, 5th St (Alley), Emam St, Bam
City
Bam

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Maryam Nikbakht
Street address
Unit 12, No 38, Jahad St, Shariatee Ave, after Thamasb abad Cross, Kerman
City
Kerman
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, Kerman 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
health
Full name of responsible person
Reza Sadeghi
Position
MSc
Other areas of specialty/work
Street address
No 10, 8th St (Alley), Abouryhan St, Sirjan
City
Sirjan
Postal code
Phone
+98 34 5423 2577
Fax
+98 34 5423 2577
Email
reza.sadegh351@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Public Health, Kerman University of Medical Sciences.
Full name of responsible person
Mohabbat Mohseni
Position
Doctor of Public Health
Other areas of specialty/work
Street address
Unit 10, No 38, Jahad St, Shariatee Ave, after Thamasb abad Cross, Kerman
City
kerman
Postal code
Phone
+98 34 1320 5094
Fax
+98 34 1320 5094
Email
mohabatm@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
health
Full name of responsible person
Reza Sadeghi
Position
MSc
Other areas of specialty/work
Street address
No 10, 8th St (Alley), Abouryhan St, Sirjan
City
Sirjan
Postal code
Phone
+98 34 5423 2577
Fax
+98 34 5423 2577
Email
reza.sadeghi351@yahoo.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
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