The effect of self-management training program using peer support on adherence to treatment and self-management behavior in hypertensive patients in Kashan in 2019
Design
A clinical trial with a parallel control group, randomized
Settings and conduct
This study will be performed in Shahid Beheshti Hospital in Kashan. Patients will be divided into two groups: intervention and control. First, two questionnaires of adherence to treatment and self-management will be completed by the two groups of intervention and control.Then each group receives a specific training by the peer person introduced. The training will include 5 sessions of 45 to 60 minutes. There is no intervention in the control group and they will receive routine blood pressure control training.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having Iranian citizenship, Ability to communicate verbally, Age 20 to 65 years, Hypertension of primary type with the approval of a cardiologist, At least 6 months have passed since the disease diagnosis, Lack of known mental and physical disability, Not participating in another study at the same time, Willingness and informed consent to participate in the study; Exclusion criteria: Systolic blood pressure more than 170 mm Hg.
Intervention groups
Intervention group: Patients in the intervention group are will divided into three subgroups. In each subgroup, self-management training in blood pressure control will be performed by peers in 5 sessions of 45 to 60 minutes during 5 weeks. In the Control group, no intervention will not perform during 5 weeks.
Main outcome variables
Adherence to treatment; Self-management behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100829004655N11
Registration date:2020-05-06, 1399/02/17
Registration timing:retrospective
Last update:2020-05-06, 1399/02/17
Update count:0
Registration date
2020-05-06, 1399/02/17
Registrant information
Name
Mohsen Taghadosi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
taghadosi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-management training program using peer support on adherence and self-management behavior in patient with hypertention
Public title
Effect of using peer support on adherence and self-management behavior
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having Iranian and Persian citizenship
The ability to communicate verbally
Age 20 to 65 years old
Having a primary hypertension with cardiologist confirmed
At least 6 months have passed since the diagnosis of the disease
The lack of physical and mental debilitating diseases known for example, MR, depression and cancer
Location in Kashan
Do not attend another study at the same time
The desire and informed consent to participate in the study
Exclusion criteria:
Patients with systolic blood pressure more than 170 mm Hg
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be convenience and based on inclusion criteria. Random allocation in two groups of intervention and control will be simple randomization. Randomization is carried out by creating a random sequence of numbers using an online tool (https://www.randomizer.org).
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 kashan University of Medical Sciences
Street address
Ravand Street, Kashan University of Medical Sciences.
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.046
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Adherence to Treatment
Timepoint
Before training, after training and 45 days after completion of intervention
Method of measurement
Treatment adherence questionnaire for patients with hypertension
2
Description
Self Management Behavior
Timepoint
Before training, after training and 45 days after completion of intervention
Method of measurement
Self-management questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the intervention group are will divided into three subgroups. In each subgroup, self-management training in blood pressure control by peers in 5 sessions of 45 to 60 minutes, once a week for five weeks will be performed.The content of the sessions will include the following. The first session includes the definition of hypertension and its cause; The second session includes risk factors for high blood pressure and ways to control it;The third session includes the general principles of hypertension treatment and its pharmacological treatments; The fourth session includes training the daily weight control, diet and proper physical activity;The fifth session includes stress management and non-smoking and alcohol consumption.
Category
Prevention
2
Description
Control group: Receive the routine training of the center and answer the questions that the researcher asks in writing by questionnaire. The routine training of the center consists of providing a training pamphlet based on the national guidelines for blood pressure control in Iran.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital, Kashan university of medical sciences
Full name of responsible person
Mohsen Taghadsi
Street address
Ravand street,Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 6633
Email
Taghadosi_m@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafshe
Street address
Ravand Street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
Taghadosi_m@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghadosi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31555 0021
Fax
+98 31 5546 6333
Email
Taghadosi_m@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghadosi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
+98 31 5546 6333
Email
Taghadosi_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamideh fatahpour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ravand Street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5263 9807
Email
Hamidehfatahpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
trauma nursing research center, Kashan University of Medical Sciences Research Center
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.