Protocol summary

Summary
Background: Hypertension is an established risk factor for atherosclerosis, coronary artery diseases, the main risk factor for other many diseases, and causes more than 7 million deaths per year in the world. The aim of this study is determine the effectiveness of a life style modification program on Knowledge, attitude, practice on hypertensive patients with angioplasty. Methods: This study was a randomized clinical trial in Shahid Chamran hospital of Isfahan with 60 hypertensive patients who had angioplasty were randomly assigned to study (n = 30) and control (n = 30) groups. Data Collection was done performed in three stages. Intervention plan was 6 education sections that were in 3 weeks and phone call follow up was one a week during first month after the intervention in the experimental group. Data analyzed using descriptive and inferential test was performed by SPSS software version 20. Results: Before intervention, the mean score of Knowledge, attitude and practice had no significant difference between the two groups (p= 0/05), but immediately after the intervention and one month after the intervention the mean score of Knowledge, attitude and practice in the experimental group was significantly more than the control group(p=0/0001). The mean score of Knowledge, attitude and practice had no significant difference between the three times in the control group (p= 0/05 ); but in the experimental group the mean score of Knowledge, attitude and practice had significant difference between before the intervention with immediately after the intervention and one month after the intervention(p=0/0001 ). Conclusion: The lifestyle modification program is effective in promoting the Knowledge, attitude and practice hypertensive patients with angioplasty. Keywords: Lifestyle, knowledge, attitude, practice, hypertension

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062420912N3
Registration date: 2015-07-01, 1394/04/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-01, 1394/04/10
Registrant information
Name
Mohsen Shahriari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2915
Email address
shahriari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of an education lifestyle modification program on knowledge, attitude & practice in patients with hypertension was done angioplasty in who reffered to Isfahan Chamran Hospital 2014
Public title
Effects life style modification program on Knowledge, attitude, practice
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: - Age of 40 years and above. - Are living in the city. - Literacy have at least read and write. - Patients with systolic blood pressure of 140 mm Hg or diastolic blood pressure 90 mm Hg or more and have more. - Were not following special diet or treatment of obesity or thinness calming techniques such as yoga, meditation, and not (black and Hvkansvn 2009, p .1298. ( - According to the records, samples of acute cardiovascular disease such as high blood pressure secondary, type 1 and 2 diabetes, hormonal disorders, kidney disease and mental illness is not (Black and Hvkansvn 2009, p .1352. ( - The doctor confirmed the clinical condition is good and there is no limit to the intervention. - Did not participate in the educational program is to control blood pressure. Exclusion criteria: - If any of research units unwillingness to continue participating in the study were excluded. - Acute stress during the study will be deleted. - During the study, blood pressure change is large due to the need to change the dose of medication is prescribed. - If the subjects in the experimental group more than 2 sessions in the absence of their training sessions.
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Shiraz Gate, St thousand acres,Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
393679

Health conditions studied

1

Description of health condition studied
hypertension
ICD-10 code
ه10-2115
ICD-10 code description

Primary outcomes

1

Description
Knowledge
Timepoint
Before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
Questionnaire

2

Description
attitude
Timepoint
before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
Questionnaire

3

Description
practice
Timepoint
Before the intervention, immediately after the intervention and one month after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
intervention Groups: group training program in six sessions over three weeks, held every 45 to 60 minutes during training sessions of lectures, Q & A and discussion is used and in cases of hypertension and complications risk factors, diet, physical activity, stress management, life, limit alcohol consumption, smoking and drug abuse prevention and , according to treatment of high blood pressure guidelines received training. It is worth noting that at the beginning of each session training manual that fits with the theme of the meeting was delivered to the sample. The second session after reviewing the previous session topics and answer questions about those issues before the performance review and feedback received over the past week. After running the program, by phone, on the educational content provided and follow the curriculum, overcome barriers, client questions and provide feedback incentives to correct knowledge, attitude and positive talk. Control group: two sessions of discussion about the experiences of people with high blood pressure, diet, exercise and reduce Vzrn was held.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
mehdi nemathbakhsh
Street address
isfahan
City
isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
fahimeh jafari
Position
msc
Other areas of specialty/work
Street address
Shiraz Gate, St thousand acres, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3441 8775
Fax
Email
jafary.fahimeh1366@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing & Midwifery Care Research Center
Full name of responsible person
mohsen shahriri
Position
phd
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 2950
Fax
Email
shahriari@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
fahimeh jafari
Position
MSc Student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 2950
Fax
Email
JAFARY.FAHIMEH1366@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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