Protocol summary

Study aim
Effect of using Orem model on self-care behaviors of elderly women with hypertension in city of Ramsar
Design
The clinical trial has a community-based, practice-oriented control group, with parallel groups, randomized
Settings and conduct
Patients with eligible hypertension who have electronic records in Ramsar city health centers, if their total score is less than 50% of the researcher's questionnaire, will be included in the research according to the sample size. In this study, self-care education program based on the Orem model Based on nursing support system, it will be educational
Participants/Inclusion and exclusion criteria
All aged women aged 60-74 years with hypertension who are in the electronic records centers of Ramsar city will form the research community
Intervention groups
Face-to-face training for 30 minutes 3 sessions once a week for 3 weeks
Main outcome variables
Compliance with diet-Propagation to drug use, weight management, physical activity, alcohol consumption and pre-interventional cats and 3 months later using standard questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180831040911N1
Registration date: 2019-04-14, 1398/01/25
Registration timing: retrospective

Last update: 2019-04-14, 1398/01/25
Update count: 0
Registration date
2019-04-14, 1398/01/25
Registrant information
Name
shahrbanoo nasresabetghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4253 7807
Email address
s.nasresabetghadam@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-24, 1397/08/02
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of using Orem model on self-care behaviors of elderly women with hypertension in city of Ramsar
Public title
The effect of using Orem model on self-care behaviors of elderly women with hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have reading and writing skills Accommodation in Ramsar city Phone Access at Home Lack of speech and hearing problems A history of over 6 months of hypertension Earn less than 50 percent of the researcher-made questionnaire based on the Orem model Female patients with hypertension based on e-mail and aged 60-74 years The desire to participate in research
Exclusion criteria:
Unwillingness to continue the research Not attending more than two training sessions Old man's death Hospital admission during study
Age
From 60 years old to 74 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the samples were selected using available sampling method and by simple random assignment method They will be divided into test and control groups. Thus, for each electronic case of patients, a number from 1 to 70 will be randomly selected, and then the number of case files in the test group and the coupled number records will be in the control group.
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
The Ethics Committee of Babol University of Medical Sciences
Street address
Shahid Gholipour Shahid Gholipour Building, Salami Building, Imam Khomeini Street
City
Langeroud
Province
Guilan
Postal code
4471667475
Approval date
2018-08-19, 1397/05/28
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.115

Health conditions studied

1

Description of health condition studied
High blood pressure
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
High blood pressure
Timepoint
Initial training, 12 weeks after intervention
Method of measurement
Blood pressure in millimeters of mercury using a digital barometer and how to measure the systolic blood pressure scale.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: this group will be educated (three one hour sessions) Based on the Orem self-care model through giving lecture, question and answer and group discussion. Intervention includes 5 steps. First step: Determine the needs of self-care patients in the three dimension(needs of self-care, evolution and deviation from individual health). Second step: Determine nursing diagnoses and goals. Third step: Planning based on self-care behaviors tailored to the needs of individuals. Fourth step: Implementation of self-care program training. Fifth step: Evaluation.
Category
Lifestyle

2

Description
Control group: In the control group no intervention will be done for the patients
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ramsar Health Centers
Full name of responsible person
Shahabanoo Nasresabetghadam
Street address
Health Center Attached to Hakim ., Sadat Shahr
City
Ramsar
Province
Mazandaran
Postal code
4471667475
Phone
+98 13 4253 7807
Email
sh.nasresabetghadam@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Ghaffari
Street address
Alzahra Nursing Faculty, Shahid Motahari St. Ramsar Square
City
Ramsar
Province
Mazandaran
Postal code
4471667475
Phone
+98 11 5522 5151
Email
sh.nasresabetghadam@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mehri Jahanshahi
Position
Master of Science - Faculty Member
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Ramsar-Enghelab Square-Imam Sajjad hospital-Fatima Zahra School of Nursing. Postal code: 4691714141
City
Ramsar
Province
Mazandaran
Postal code
4717647745
Phone
+98 11321995926
Fax
+98 11 3219 0181
Email
mehrigahanshahi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehri jahanshahi
Position
Master of Science - Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alzahra Nursing Faculty, Shahid Motahari St. Ramsar Square
City
Ramsar
Province
Mazandaran
Postal code
4471667475
Phone
+98 11 5522 5151
Fax
+98 11 3219 0181
Email
mehrigahanshahi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Shahrbanoo Nasresabetghadam
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Gholipour Shahid Gholipour Building, Salami Building, Imam Khomeini Street
City
Langruod
Province
Guilan
Postal code
4471667574
Phone
+98 13 4253 7807
Email
s.nasresabetghadam@mubabol.ac.ir

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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