Designing a theory baesd educational intervention on improving adherence to treatment in patients with hypertension in sarab city : A social networking trial
Findings of the study can provide an accurate and effective educational model with the aim of increasing drug adherence and ultimately improve the quality of life of patients with hypertension.
Design
This randomized controlled trial, with parallel, single-blind groups, was performed on 130 patients with hypertension. All participants complete the health action process approach questionnaire.Then the samples will be randomly divided into experimental and control groups.
Settings and conduct
After completing health action process approach questionnaire, the samples that were randomly selected from four sarab comprehensive health centers will be divided into two experimental and control groups. The experimental group will then receive the online training intervention. The control group will receive routine actions.The outcome evaluator did not know how to randomize the disease And examine the data related to the outcome variables, regardless of the groups of individuals.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Morbidity of primary hypertension for at least the last 6 months،Having media literacy and familiarity with and access to social networks،Age range 20 to 65 years؛Criteria for non-entry:Participation in educational programs related to drug adherence،Morbidity of psychiatric disorders or addiction،Any need for medication changes in patients for any reason،Another person is responsible for giving the patient medicine.
Intervention groups
The experimental group receives online virtual training using social networks in three sessions. Participantsin the control group perform routine activities
Main outcome variables
drug adherence، blood pressure control، self-efficacy، action planning، coping planning، behavioral intent، perceived risk، expectation of outcome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200617047816N1
Registration date:2020-09-08, 1399/06/18
Registration timing:retrospective
Last update:2020-09-08, 1399/06/18
Update count:0
Registration date
2020-09-08, 1399/06/18
Registrant information
Name
Vahid Farajzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 4323 7840
Email address
farajzadehv35@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-24, 1398/12/05
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
2020-02-24, 1398/12/05
Actual recruitment end date
2020-03-10, 1398/12/20
Trial completion date
2020-06-09, 1399/03/20
Scientific title
Designing a theory baesd educational intervention on improving adherence to treatment in patients with hypertension in sarab city : A social networking trial
Public title
Designing a theory baesd educational intervention on improving adherence to treatment in patients with hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Morbidity of primary hypertension
Having media literacy and familiarity with and access to social networks
Conscious consent and voluntary participation in research
Have hypertension for at least the last 6 months
Age range 20 to 65 years
Exclusion criteria:
Participation in educational programs related to drug adherence
Morbidity of psychiatric disorders or addiction and any disorders that prevents the effective and complete presence of the patient in the sessions and affects the results of the research
Any need for medication changes in patients for any reason.
Another person is responsible for giving the patient medicine
Taking drugs that affect their consciousness.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
130
Actual sample size reached:
130
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, stratified random and block method is used. The randomization unit is individual and the randomization tool is a sealed envelope. Randomization layers in this study are comprehensive health centersThe present study is single-blind. The outcome assessor is unaware of how the disease is randomly assigned and will review data on outcome variables regardless of groups of individuals.
After collecting the data, the groups are named in letters so that the analyzer is not informed about the intervention and control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome evaluator did not know how to randomize the disease
And examine the data related to the outcome variables, regardless of the groups of individuals.
After collecting the data, the groups are named in alphabetical order so that the analyst from the intervention and control group is not informed.
Placebo
Not used
Assignment
Parallel
Other design features
This study is done online. Participants are trained through cyberspace.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences., Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2020-04-20, 1399/02/01
Ethics committee reference number
IR.QUMS.REC.1399.047
Health conditions studied
1
Description of health condition studied
Primary hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Drug compliance
Timepoint
Before the intervention, one month ، two & Six months after the intervention, the questionnaire is completed.
Method of measurement
The Medication Adherence Rating Scale
2
Description
Health action process model subscale
Timepoint
Before the intervention, one month ، two & Six months after the intervention, the questionnaire is completed.
Method of measurement
Health action process approach subscale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with hypertension receive Online group group virtual training adherence to treatment consisting of three training sessions of 30 to 45 minutes, using social networks .In order to evaluate the effectiveness of the educational program, patients will be evaluated through questionnaires in three time periods, before the intervention, two and six months after the intervention.Meetings are based on behavior change techniques and include: health outcomes, importance of outcomes, volunteer empowerment, focus on past success, action planning, problem solving, and coping planning.
Category
Behavior
2
Description
Control group: Participants in the control group perform routine activities.(Such as: measuring blood pressure, monitoring patients, teaching a healthy lifestyle).At the end of the study, an intensive training session is held for them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarab University of Medical Sciences
Full name of responsible person
Vahid Farajzadeh
Street address
Sarab University of Medical Sciences., Imam Khomeini Blvd., Sarab
City
Sarab
Province
East Azarbaijan
Postal code
5471915931
Phone
+98 41 4322 4586
Email
farajzadehv35@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Pakpur Haji Agha
Street address
Qazvin University of Medical Sciences., Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
pakpour_amir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Vahid Farajzadeh
Position
Staff
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Sarab University of Medical Sciences., Imam Khomeini Blvd., Sarab
City
Sarab
Province
East Azarbaijan
Postal code
5471915931
Phone
+98 41 4323 7840
Email
farajzadehv35@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr,Amir Pakpur Haji Agha
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Qazvin University of Medical Sciences., Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
amir.pakpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Vahid Farajzadeh
Position
Staff
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Sarab University of Medical Sciences., Imam Khomeini Blvd., Sarab
City
Sarab
Province
East Azarbaijan
Postal code
5471915931
Phone
+98 41 4323 7840
Email
farajzadehv35@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Master's instructions will be followed.
When the data will become available and for how long
According to the plan of Qazvin School of Health
To whom data/document is available
University of Medical Sciences
Under which criteria data/document could be used
At the discretion of the professor
From where data/document is obtainable
Qazvin Medical Sciences
What processes are involved for a request to access data/document
According to the protocols of Qazvin University of Medical Sciences