A clinical trial study on intervention based on the theory of planned behavior on improving self-care behavior of patients with hypertension in two intervention and control groups with blood pressure control.
Objective: Mean score of the planned behavior theory structures in patients with hypertension in intervention and control groups will be determined and compared. The difference between the mean performance score of following diet plan and structural theory and physical activity and using drug after the intervention will be determined.
Design:
This study will be conducted as controlled trial. The intervention group will consist of patients with hypertension and its history at least a year that will refer to centers No. 14 in Rasht. The control group will be the patients to be selected in centers No. 13 in Rasht.
Setting and conduct:
The tool to be used will be a questionnaire including demographic information, and questions related to the control of blood pressure history, and questions about the planned behavior theory including persons’ attitude on hypertension, mental norm and perceived behavioral control and intention of conducting behavior to control blood pressure. To assess the nutritional information, FFQ 148 will be used.
Inclusion criteria:
People with hypertension; people living in health centers of rural areas; Having history of hypertension during the previous one year; age above 45 years until 65 years old; patient’s participation with satisfaction.
Exclusion Criteria:
Patient’s withdrawal from going on; A patient’s life-threatening event or death during conducting program; Changing patient’s inhabitant to outside of research area.
Intervention:
Executing educational program by the researcher in the intervention group.
Main outcome measures:
The aim will be designed to promote and expand self-care behaviors in controlling blood pressure as the primary outcome variable.
General information
Acronym
Full blood pressure patients self-care
IRCT registration information
IRCT registration number:IRCT2016011622984N1
Registration date:2016-01-16, 1394/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-16, 1394/10/26
Registrant information
Name
Fardin Mehrabian
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 133335415
Email address
mehrabian@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial study on intervention based on the theory of planned behavior on improving self-care behavior of patients with hypertension in two intervention and control groups with blood pressure control.
Public title
Effects of intervention based on the theory of planned behavior on improving self-care behavior in hypertension patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People with high blood pressure; People living near health centers of rural areas and having a medical record in the health house; History of hypertension during one year ago; Age above 45 years old and below 65 years old; Patient's participation in research with his (her) satisfaction.
Exclusion criteria:
Patient's withdrawal from the study whenever s(he) wants, if (s)he does not want to continue; A life-threatening event or death during conducting intervention programs for patients;
Age
From 45 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Choose a health center in the center of the quota by random selection of patients in each health center is a table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
before and 2.5 months after the educational intervention
Method of measurement
Manual gearboxes
Secondary outcomes
1
Description
average structures perceived behavioral theory
Timepoint
Before and 2.5 month after intervention
Method of measurement
The questionnaire was created by the researcher
2
Description
average physical activity
Timepoint
Before and 2.5 month after intervention
Method of measurement
GPAC Questionnaire
3
Description
average use a drug
Timepoint
Before and 2.5 month after intervention
Method of measurement
The questionnaire was created by the researcher
4
Description
average food intake and the DASH diet group
Timepoint
Before and 2.5 month after intervention
Method of measurement
FFO Questionnaire
Intervention groups
1
Description
" Intervention group:
three educational sessions will be held separately in three different topics,and teaching aids and CD s and pamphlets related to the same session will be used.
The overall aim of the first session:
To increase patients' awareness of hypertension and familiarity with examining the current situation in their behaviors associated with blood pressure control
Session period: 45 minutes
Educator: researcher
The overall aim of the second session:
The patients' familiarity with the outcomes of their lifestyle modification as the main solution to promote self-care behaviors with an emphasis on the structure of the perceived behavioral control in high blood pressure control
The overall aim of the third session;
Familiarity with diet plan used in patients with hypertension and to determine and change their attitude toward the use of this diet plan in order to promote appropriate nutritional behavior.
The main aim of the study is that a program is designed to promote and expand self-care behaviors in controlling blood pressure as the primary outcome variable.
Educational content of sessions includes general information on high blood pressure (definition, symptoms, complications, prevention and treatment) and an emphasis on self-care behaviors in controlling high blood pressure, such as physical activity, proper nutrition and the use of medication. . Educational materials including pamphlets and posters and educational CD will be used in each session. Educational methods used in the sessions will be as a combination of lecture, question and answer, group discussion and brainstorming."
Category
Lifestyle
2
Description
"control group: In the control group,no educational intervention performed by the researcher. The control group did not receive any intervention by the researcher and the 2.5 month training package that was given to the intervention group was the control group "