Objective: Evaluating the effects of Orem's self-care program on self- efficacy and quality of life in hypertensive patients. Type of experiment: Randomized. Inclusion criteria: A definitive diagnosis of hypertension by cardiologist; History of taking at least one anti-hypertensive medication for one year; Age of 18-55 years; Having a minimum education level (elementary); Not participated in the same study; Ability in Persian language comprehension and communication; Tendency to participate in the study; Have filled informed consent form; Not working at medical services. Exclusion criteria: Known psychological disorders; History of addiction in past one year; Other chronic diseases; History of major heart surgery during past six months; Method: By randomization, the two groups (intervention and control) are followed in exactly the same way. Population studied: All patients with hypertension referred to Mamasani Valiasr hospital. Target sample size: 80 cases. Interventions: Patients in intervention group will receive four 45 minutes teaching sessions weekly during one month and the manner of educated program adherence will be followed up with a phone call.
Primary outcomes of this project is the study of patient's self-efficacy and quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081323606N1
Registration date:2016-02-07, 1394/11/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Farzaneh Kazemi Ara
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4254 7375
Email address
stud2392002274@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-06-20, 1394/03/30
Expected recruitment end date
2015-07-24, 1394/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Self- Efficacy and Quality of Life hypertensive patients with and without Orem's self-care education
Public title
The effect of Orem's self-care program on Self- Efficacy and Quality of Life in hypertensive patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: A definitive diagnosis of hypertension by cardiologist; History of taking at least one anti-hypertensive medication for one year; Age of 18-55 years; Having a minimum education level (elementary); Not participated in the same study; Ability in Persian language comprehension $ communication; Tendency to participate in the study; Have filled informed consent form; Not working at medical services. Exclusion criteria: Known psychological disorders; History of addiction in past one year; Other chronic conditions such as: Epilepsy, C.V.A, cancer, physical disability and neurological disorders; History of major heart surgery during past six months; long hospitalization since two years ago.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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 Shiraz university of medical Sciences
Street address
Seventh floor, Shiraz university of medical Sciences and health services, Zand Blvd.
City
Shiraz
Postal code
71345-1978
Approval date
2015-06-21, 1394/03/31
Ethics committee reference number
IR.SUMS.REC.1394.44
Health conditions studied
1
Description of health condition studied
Hypertensive diseases
ICD-10 code
I10-I15
ICD-10 code description
Hypertensive diseases
Primary outcomes
1
Description
Quality of life
Timepoint
before intervention, exactly after and eight weeks after intervention
Method of measurement
Mac new quality of life questionnaire
2
Description
Self-Efficacy
Timepoint
before intervention, exactly after and eight weeks after intervention
Method of measurement
SUPPH self-Efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Patients in intervention group will receive four 45 minutes teaching sessions weekly during one month. The First 3 sessions are personal and fourth session is for solving problems and sharing experiences. Also quality of life and Self-efficacy questionnaire will be filled in fourth session. Final intervention step includes phone call follow-up in order to evaluate the applying taught issues by cases, answer their questions and encourage them for active participation in self-care activities.
Category
Other
2
Description
Control group: No Intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mamasani Valiasr Hospital
Full name of responsible person
Farzaneh Kazemi ARA
Street address
Mamasani
City
Mamasany
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
basir hashemi
Street address
Seventh floor, Shiraz university of medical Sciences and health services, Zand Blvd.
City
Shiraz
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, Shiraz 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
Shiraz university of medical sciences
Full name of responsible person
Zahra Khademian
Position
Nursing ph.d.
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi hospital, Namazi Sq. Shiraz
City
shiraz
Postal code
Phone
+98 71 3626 7101
Fax
Email
zahrakhademian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Zahra Khademian
Position
Nursing ph.d.
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi hospital, Namazi Sq. Shiraz
City
Shiraz
Postal code
Phone
+98 71 3626 7101
Fax
Email
zahrakhademian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Zahra khademian
Position
Nursing ph.d.
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi hospital, Namazi Sq. Shiraz
City
Shiraz
Postal code
Phone
+98 71 3626 7101
Fax
Email
zahrakhademian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)