Protocol summary

Study aim
Determining the effect of educational program based on protection motivation theory in promoting coronavirus prevention behaviors among the elderly
Design
A clinical trial with a control group, with parallel groups, blinded, randomized, will be performed on 200 elderly in a simple random way and individuals will be followed up after two months.
Settings and conduct
Participants are randomly selected from the retirement centers of Hamadan and are placed in each of the control and control groups. Training's will be provided to both groups using virtual networks.
Participants/Inclusion and exclusion criteria
Entry conditions included: 60 to 75 years old/ No history of covid-19 disease in oneself or family/ Smartphone access. No entry conditions included: People with physical and mental disabilities/ Lack of functional independence
Intervention groups
People will be randomly divided into two groups of intervention and control. People in the intervention group will be taught how to protect themselves against covid-19 disease, and people in the control group will be taught how to increase the quality of sleep in the elderly.
Main outcome variables
Protective behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200902048598N1
Registration date: 2020-09-28, 1399/07/07
Registration timing: registered_while_recruiting

Last update: 2020-09-28, 1399/07/07
Update count: 0
Registration date
2020-09-28, 1399/07/07
Registrant information
Name
mohadese sadri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3822 6081
Email address
mohadese.sdr.1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Program Based on the Protection Motivation Theory in Promoting Protective Behaviors Against COVID-19 in Elderly
Public title
Evaluation of the effect of education in the prevention of covid-19
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to speak and read Persian No history of covid-19 in oneself or family (pair or children) Internet access Smartphone access Ability to use social networks Elderly members of retirement centers Elderly people have completed an informed consent form and a questionnaire to participate in the study Age 60 to 75 years
Exclusion criteria:
People with physical and mental disabilities Lack of functional independence
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
After randomly selecting two centers from the list of retirement centers in Hamadan, one center is considered as a simple random intervention group and the other as a control group, and then the members of each center are selected randomly.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in the study are unaware of whether they are in the intervention or control group, so that people in both groups receive educational intervention, but in the control group, the educational intervention is related to another topic.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Building No. 4, Shariati Crossroad., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
65178
Approval date
2020-08-22, 1399/06/01
Ethics committee reference number
IR.UMSHA.REC.1399.476

Health conditions studied

1

Description of health condition studied
Protective behavior against covid-19 disease in the elderly
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified

Primary outcomes

1

Description
protective behaviors
Timepoint
Behavior measurement before the start of the study and 2 months after the intervention
Method of measurement
The data collection tool includes a researcher-made questionnaire designed by modeling similar studies and consists of two general sections of demographic information and questions related to the structures of protection motivation theory. Questionnaires will be completed by self-report method by study participants.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receive a training program on protective behaviors against covid-19 disease
Category
Behavior

2

Description
Control group: Receive an educational program on increasing the quality of sleep in the elderly
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamedan Retirement Center
Full name of responsible person
Roholah Afshar
Street address
no.274, Honarestan blvd, Hamadan city
City
Hamadan
Province
Hamadan
Postal code
6516763468
Phone
+98 81 3833 1056
Fax
+98 81 3833 1023
Email
info@cspf.ir
Web page address
http://hamadan.payesh8523.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
No. 4, Shariati Crossroad., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
m_research@umsha.ac.ir
Web page address
http://www.umsha.ac.ir/index.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Majid Barati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No. 4, Shariati Crossroad., Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0025
Fax
+98 81 3838 0509
Email
m_baratimehr@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Majid Barati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Daneshgah-e-Bu Ali Sina, Hamedan, Hamadan Province
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0025
Fax
+98 81 3838 0509
Email
Barati@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Majid Barati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Daneshgah-e-Bu Ali Sina, Hamedan, Hamadan Province
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0025
Fax
+98 81 3838 0509
Email
Barati@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We do not have a license from the university in this regard
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...