The aim in this study is done to compare the effects of two educational methods of direct and indirect self-care on Quality of life of hypertension patients . 90 patients referee to medical clinics will randomly select and placed into three groups.Patients will complete quality of life questionnaires before training. Then a self-care educational program based on Orem Self Care Model Designing and in first group of patients will implemented by direct education. In second group of educational teaching package to be given to them to read at home. The third group do not receive any training . Two months after the program, three groups complete quality of life questionnaire again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302038348N4
Registration date:2013-03-16, 1391/12/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-16, 1391/12/26
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-12-05, 1391/09/15
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of two educational methods of direct and indirect self-care program on Quality of life of hypertension patients
Public title
Compare the effects of education program on Quality of life of hypertension patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 35-65years,Patients with primary hypertension,Literacy,Good physical condition and be willing to receive education, At least one year and be more patient with hypertension
Exclusion criteria: Receive education from other sources, Patients with Blood Pressure crisis
Age
From 35 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Kashan University of Medical Sciences
Street address
Kashan, Ravand, kashan University of Medical Science
City
Kashan
Postal code
Approval date
2012-05-06, 1391/02/17
Ethics committee reference number
8838
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I00-I99
ICD-10 code description
Hypertensive diseases
Primary outcomes
1
Description
Direct education
Timepoint
Before and after two month
Method of measurement
Questionnaire
2
Description
Indirect education
Timepoint
Before and after two month
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Blood Pressure
Timepoint
After two month
Method of measurement
Mercury sphygmomanometer
2
Description
Qulity of life
Timepoint
Before and after two month
Method of measurement
Quality of life questionnaire sf36
Intervention groups
1
Description
Direct education group: Direct education is in two sessions in the classroom at two hours.
Category
Prevention
2
Description
Indirect education group: Educations are packages to patients.
Category
Prevention
3
Description
Control group: Do not receive any education.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Centers of Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Street address
Parastar Street, Ravand, Kashan University of Medical
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Street address
Parastar Street , Ravand, Kashan University of Medical
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Parastar Street, Ravand, Kashan University of Medical
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
+98 55 56633
Email
mirbagher_n@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Parastar Street, Ravand, Kashan University of Medical
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
mirbagher_n@kaums.ac.irsalam_20012003@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Parastar Street, Ravand, Kashan University of Medical
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
+98 55 56633
Email
salam_20012003@yahoo.co.uk
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)