Objectives: Determining the effectiveness of educational program on adherence of patient with high blood pressure in Sayyad Shirazi educational hospital
Design: Controlled clinical trial (single blind)
Setting and conduct: 196 qualified patients with hypertension, will be selected through convenience sampling to detect patients' adherence compliance of patient, then 98 patients with low adherence will allocate into two intervention and control group by using stratified random allocation. Lifestyle modification education will be took place in heart clinic unit by trained practitioners based on lifestyle modification guideline in intervention group. Patients' adherence and blood pressure will be measured before and after intervention in both groups for comparing.
Major Inclusion and Exclusion criteria: Inclusion criteria will include age from 18 to 65 years; having the ability to read and write; having systolic blood pressure more than 140 and less than 169; having diastolic blood pressure more than 90 and less than 109; at least 6 months history of treatment; having complete alertness; hearing and speech ability; don't be pregnant; not having known psychiatric disorders and chronic illness; not using opium or alcohol. Exclusion criteria will include don't want to continue participation and travel or migration during study.
Intervention: Two hours face to face education will be done twice a week for two weeks based on lifestyle modification guideline.
Main outcome measures: Patients' adherence to treatment and blood pressure
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014070117237N4
Registration date:2015-08-15, 1394/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-15, 1394/05/24
Registrant information
Name
Mahnaz Modanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 6900
Email address
modanloo.mahnaz@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research & Technology, Golestan University of Medical Sciences
Expected recruitment start date
2015-07-03, 1394/04/12
Expected recruitment end date
2015-11-04, 1394/08/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the educational program on adherence of patients with high blood pressure
Public title
The effect of the education on adherence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age from 18 to 65 years; having the ability to read and write; having Systolic Blood Pressure more than 140 and less than 169; having Diastolic Blood Pressure more than 90 and less than 109; at least 6 months history of treatment; having complete alertness; hearing and speech ability; don't be pregnant during participating in study; not having known psychiatric disorders; don't have chronic illness such as cancer, lupus, advanced heart failure, ARDS, CVA and diabetes; not using opium or alcohol.
Exclusion criteria: don't want to continue participation; travel or migration during study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will allocate into two intervention and control group by using stratified random allocation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Postal code
4934174515
Approval date
2015-06-07, 1394/03/17
Ethics committee reference number
ir.goums.rec.1394.44
Health conditions studied
1
Description of health condition studied
Hypertention
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Adherennce
Timepoint
Before intervention and two weeks after intervention
Method of measurement
Using checklist to measur adrerenct to treatment in diets, excercise and drug
Secondary outcomes
1
Description
Level of blood pressure
Timepoint
Before intervention and two weeks after intervention
Method of measurement
Using sphygmomanometer
Intervention groups
1
Description
Intervention group: Two hours face to face education based on lifestyle modification guideline will be done twice a week for two weeks.