Protocol summary

Study aim
The effect of health-promoting behaviors training on self-care in hypertensive patients
Design
Clinical trial with intervention and control group, Non-randomize, with a sample size of 106 people
Settings and conduct
Sampling will done among patients with primary hypertension in clinic of hospital. Intervention group will be trained in three sessions under the training of health promoting behaviors. The control group will not receive any training until the end of the study. Data were collected from both groups using a demographic and self-care questionnaire for chronic diseases before and one month after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Have at least reading and writing skills, Diagnosis of hypertension at least in the last 3 months by a cardiologist Exclusion criteria: Complications of hypertension (including heart failure, renal failure, myocardial infarction, cerebrovascular accident, Disorders of the vasculaure of the eye)
Intervention groups
Intervention group: In addition to receiving routine care and treatment, The intervention will be implemented in the form of Training of Health Promoting Behaviors in 3 sessions of 45 minutes. Control group: Only the care and routine treatment will be received until the end of the study.
Main outcome variables
Self-care score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180717040502N1
Registration date: 2018-10-14, 1397/07/22
Registration timing: retrospective

Last update: 2018-10-14, 1397/07/22
Update count: 0
Registration date
2018-10-14, 1397/07/22
Registrant information
Name
Leila Bhmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3333 6157
Email address
bahmani.l@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
2018-06-21, 1397/03/31
Scientific title
The effect of health-promoting behaviors training on self-care in hypertensive patients
Public title
The effect of education on self-care in hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of hypertension at least in the last 3 months Have at least reading and writing skills Absence of Acute Disease and chronic illness
Exclusion criteria:
Cases of other chronic diseases Complications of hypertension Inability to read and write
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
Actual sample size reached: 103
Randomization (investigator's opinion)
Not 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 Iran University of Medical Sciences
Street address
Iran University of Medical Science, Next to Milad Tower, Hemmat highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-10-27, 1396/08/05
Ethics committee reference number
IR.IUMS.FMD.REC1396.9311690002

Health conditions studied

1

Description of health condition studied
High blood pressure
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Self-care score in people with hypertension
Timepoint
At the beginning of the study and one month after the intervention
Method of measurement
Self-care questionnaire in hypertensive patients

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to receiving routine care and treatment, The intervention will be implemented in the form of Training of Health Promoting Behaviors in 3 sessions of 45 minutes.
Category
Lifestyle

2

Description
Control group: Only the care and routine treatment will be received until the end of the study.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Lorestan University of Medical Sciences, Shahid Rahimi Hospital
Full name of responsible person
Leila Bahmani
Street address
Shahid Rahimi Hospital, Safavi Bridge, Azadi Square, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813816314
Phone
+98 66 3333 6145
Fax
+98 66 3333 6151
Email
lums2006@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malekoti
Street address
Iran University of Medical Science, Next to Milad Tower, Hemmat Highway, Teharan, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86710
Fax
Email
research@iums.ac.ir
Web page address
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Leila Bhmani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran University of Medical Science, Next to Milad Tower, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8610 2198
Fax
+98 21 8820 1978
Email
bahmani.L@tak.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Bahmani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21867102198
Fax
+98 21 8820 1978
Email
bahmani.L@tak.iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Bahmani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21867102198
Fax
+98 21 8820 1978
Email
bahmani.L@tak.iums.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
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
Loading...