Comparing the effect of education through social networks with face-to-face teaching on adherence to treatment in patients with hypertension
Design
A clinical trial with a control group, with parallel groups, one-sided blind, randomized, will be conducted with the participation of 210 patients. A random distribution method with a block design will be used for randomization.
Settings and conduct
Sampling is done in the heart clinics of Ayatollah Mousavi and Valiasr hospitals in Zanjan city among patients with primary hypertension. Two intervention groups and one control group will be present in this study. Before the intervention, their demographic characteristics and treatment adherence will be checked. The patients of the experimental group who receive face-to-face training will receive face-to-face training from the researchers during four sessions in addition to receiving routine interventions. In the virtual educational group, in addition to routine interventions, the same educational information (with the face-to-face group) will be provided through the virtual facilities. The control group will only receive routine interventions. Immediately, one month, and three months after the intervention, the treatment adherence will be collected again from all three groups. In this study, the statistician will not know about the groups.
Participants/Inclusion and exclusion criteria
-Age above 18 years
-Having a history of hypertension for at least six months, which a -cardiologist has confirmed.
-Being literate in reading and writing
-Not having secondary and treatment-resistant hypertension.
-Absence of severe mental/psychological problem
-Having the patient's smartphone and access to the Internet
-Informed consent to participate in the study
Intervention groups
The virtual educational intervention group
The face-to-face educational intervention group
Main outcome variables
Treatment adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140427017454N6
Registration date:2022-10-06, 1401/07/14
Registration timing:prospective
Last update:2022-10-06, 1401/07/14
Update count:0
Registration date
2022-10-06, 1401/07/14
Registrant information
Name
kourosh Amini
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 243377251314
Email address
korosh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of education through social networks with face-to-face teaching on adherence to treatment in patients with hypertension
Public title
Comparison of the effect of education through social networks with face-to-face teaching on adherence to treatment in patients with hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years of age
Having a history of hypertension for at least six months, which a cardiologist confirmed.
Being literate in reading and writing
Not having secondary, and treatment-resistant hypertension
Absence of severe mental/psychological disturbances
Having the patient's own smart cell phone and access to the Internet
Having informed consent to participate in the study
Exclusion criteria:
Concurrent participation in another study or similar educational program
Impossibility to continue participating in the study for any reason
Not completing data gathering tools
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
The distribution of patients in three groups will be by using the randomized block design. Based on this, the patients who meet the inclusion criteria will be equally distributed into three groups; Intervention group A (virtual training), B (face-to-face training), and C (control group). Since we will have three groups in this study, it is planned to have blocks of six in number. In the random distribution of patients in three groups, all possible forms of blocks with the equal presence of all three groups will be determined and placed inside separate envelopes. The project manager will randomly select the envelopes and inform the sampler of each patient's grouping order. For example, Block NO one may be arranged as AABBCC; This means that the first and second eligible patients will be assigned to intervention group A (virtual education), the following two patients to the face-to-face education group (group B), and the subsequent two patients to the control group (group C).
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the study's design, only blinding will be possible for the statistical analysis stage of the data. In other words, the statistician will be unaware of the participating groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Azadi boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2022-09-29, 1401/07/07
Ethics committee reference number
IR.ZUMS.REC.1401.196
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
Treatment adherence
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention, and three months after the intervention
Method of measurement
The Medication Adherence Questionnaire (MAQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (face-to-face): The way of conducting the educational intervention in the face-to-face group will be that it will be done once a week on Tuesday at the appointed time for four weeks with the coordination of the patients of this group. The patients of this group attend an educational class at the scheduled time in the heart clinics of Valiasr and Ayatollah Mousavi hospitals in Zanjan city. In the first session (first week), lectures, questions, and answers will give educational information related to the nature of high blood pressure disease and the effective factors to cause it. In the second session (second week), the content taught in the previous week is reviewed, and then the patients of this group are taught how to control high blood pressure and the importance of controlling it with the help of PowerPoint.In the third session (third week), while reviewing the contents of the previous two sessions and questions and answers related to the learned content, educational information regarding the importance of following the drug and behavioral regimen and its effect on blood pressure control in the form of a lecture and using It is presented from the lecture. In the fourth session (the last week), the content taught in the previous sessions will be summarized. Then the patients will be taught how to measure blood pressure using the blood pressure device. In the next step, the volunteers will be asked to measure the blood pressure of other peers in the researcher's presence. Finally, patients are advised to teach the learned method to their family members so that family members can regularly control their blood pressure.
Category
Behavior
2
Description
Intervention group (virtual): First, a group is created in one of the virtual software, such as WhatsApp, and sample members enter the group. Then, the educational content of the first session, which is related to the nature of hypertension and the factors affecting it, are sent to the group in the form of text and voice. The patients are told that they can discuss their problems in the group if they have any doubts or questions. Or they discuss it privately with the group manager (researcher). In the second session, educational information on how to control high blood pressure and the importance of controlling it will be sent in the form of a PowerPoint and pictures. In the third session, the importance of following the medication and behavioral regimen and its effect on controlling high blood pressure will be discussed, which will be sent to the group in the form of text, voice, and educational clips. In the last session, an educational clip related to the method of measuring systolic and diastolic blood pressure using a blood pressure device, along with additional explanations in the form of text and voice, will be sent to the group. At the end of the session, we will encourage the patients to teach the learned method to their family members so that their blood pressure can be controlled regularly by family members.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Valieasr Hospital
Full name of responsible person
Dr. Mohammad Hassan Rostamkhani
Street address
Valiasr Hospital, Valiasr Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Fax
+98 24 3377 0751
Email
valiasr@zums.ac.ir
2
Recruitment center
Name of recruitment center
Zanjan Mosavi Hospital
Full name of responsible person
ِDr. Mostafa Azizi
Street address
Mousavi Hospital., Gavazang Road., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 1199
Fax
+98 24 3313 1203
Email
mousavi@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nedri
Street address
Vice President of Research and Technology., Zanjan University of Medical Sciences., Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4770
Email
Research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Kourosh Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr Sobouti (Gavazang) Blvd., Central Campus of Zanjan University of Medical Science., School of Nursing and Midwifery
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
korosh@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Kourosh Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr Sobouti (Gavazang) Blvd., Central Campus of Zanjan University of Medical Science., School of Nursing and Midwifery
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
korosh@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Kourosh Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr Sobouti (Gavazang) Blvd., Central Campus of Zanjan University of Medical Science., School of Nursing and Midwifery
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
korosh@zums.ac.ir
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
Not applicable
Informed Consent Form
Yes - There is 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
All data will be shared after the de-identification of study participants and publication of results.
When the data will become available and for how long
The data availability period will start immediately after the results are published.
To whom data/document is available
Only researchers working in academic and scientific research centers and nurses working in hospitals can access the data of this study.
Under which criteria data/document could be used
Suppose the purpose of accessing the data is to develop research projects in the future or improve services to patients. The condition of access to the data will be a written and reasonable request of the applicant.
From where data/document is obtainable
Those who are interested in receiving the data can send an email to the project manager at Korosh@zums.ac.ir.
What processes are involved for a request to access data/document
The applicant can receive the data during an email while introducing himself and the purpose of accessing the data. The maximum response time to the requester will be one week.