Determining the effect of educational intervention based on social support theory in reducing stress caused by COVID-19 disease epidemic in people with diabetes
Design
Samples are 212 people. They will be randomly assigned to the intervention and control groups. The study will be parallel groups and single blind. 106 people in the intervention group will be sampled randomly and 106 people in the control group will be randomly selected through multi-stage cluster sampling
Settings and conduct
The participants in the intervention group will be chose from Bandar Abbas Diabetes Clinic and the control group from the comprehensive health service centers of Rudan city. In this study, people do not know their allocation to the the control and intervention groups but the researcher is aware of the allocation so the study is single blind. The groups are also selected from two different cities so that people are least likely to meet.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People over 18 years old with a definite diagnosis of diabetes; informed consent; Ability to use cyberspace; Ability to read and write. Non-inclusion criteria: Dissatisfaction with participating in the study;Occurrence of a specific disease;having a serious problem in mental and physical health ; suffering from COVID-19
Intervention groups
In this study, there will be two groups of intervention and control. In the control group, only pre-test and post-test will be done. In the intervention group, after the pre-test, educational intervention will be done according to the structures of the social support model. Telephone conversations and educational content in cyberspace After three months, the effects of the educational intervention will be examined by conducting a post-test.
Main outcome variables
Emotional support; informational support; instrumental support; appraisal support
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201213049693N1
Registration date:2021-02-13, 1399/11/25
Registration timing:registered_while_recruiting
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
Laleh Hassani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 6202
Email address
laleh_hassani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-29, 1399/10/09
Expected recruitment end date
2021-02-16, 1399/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on social support theory on the reduction of stress related to COVID-19 in diabetic patients
Public title
The effect of educational intervention based on social support theory on the reduction of Stress related Covid-19 in Diabetic Patients in Bandar Abbas
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old with a definite diagnosis of diabetes
Satisfaction to enter the study in writing and consciously
Ability to use cyberspace
Ability to read and write
Exclusion criteria:
Reluctance to enter the study
Occurrence of a specific disease in during the study
Without having a serious problem in mental and physical health
With Covid-19 infection
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
212
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The sampling location of the intervention and control groups is selected in such a way that the least contact between the samples of the two groups is likely. The intervention group will be selected from the patients referred to Bandar Abbas Diabetes Clinic and the control group from the Health Service Centers of Rudan city.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Jomhoori-e-Eslami street
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Approval date
2020-10-19, 1399/07/28
Ethics committee reference number
IR.HUMS.REC.1399.370
Health conditions studied
1
Description of health condition studied
Stress caused by Covid 19 in Diabetic patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Emotional support
Timepoint
Before the intervention and three months after the intervention
Method of measurement
researcher-made questionnaire
2
Description
Information support
Timepoint
Before the intervention and three months after the intervention
Method of measurement
researcher-made questionnaire
3
Description
Instrumental support
Timepoint
Before the intervention and three months after the intervention
Method of measurement
researcher-made questionnaire
4
Description
Appraisal support
Timepoint
Before the intervention and three months after the intervention
Method of measurement
researcher-made questionnaire
5
Description
Perceived stress caused by COVID-19
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Questionnaire to assess the perceived stress caused by COVID-19
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, educational classes, telephone conversations, sending educational content based on the structures of the social support model in order to reduce the stress caused by COVID-19 in diabetic patients will be done.The type of intervention, types of intervention target groups, educational content, educational methods, number and timing of educational classes will be determined according to the analysis of pre-test
Category
Behavior
2
Description
Control group: No intervention will be performed in the control group, and the control group will receive the usual training of the Health Service Centers. Including: visit by a doctor, follow-up and training by health care providers
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bandar Abbas Diabetes clinic
Full name of responsible person
Dr Ahmad Behzad
Street address
Payambar Aazam Medical Educational Complex; Jomhory Eslami Blvd.
City
Bandar-e Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Email
shmh@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
ِDr.Teamur Aghamolaei
Street address
Payambar Aazam Medical Educational Complex; Jomhory Eslami Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7192
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Laleh Hassani
Position
Science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jomhory Eslami Blvd.
City
Bandarabaas
Province
Hormozgan
Postal code
79119916753
Phone
+98 76 3333 6202
Fax
Email
laleh_hassani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Laleh Hassani
Position
Science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jomhory Eslami Blvd.
City
Bandarabaas
Province
Hormozgan
Postal code
7919916753
Phone
+98 76 3333 6202
Fax
Email
laleh_hassani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Laleh Hassani
Position
Science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jomhory Eslami Blvd.
City
Bandarabaas
Province
Hormozgan
Postal code
7919916753
Phone
+98 76 3333 6202
Fax
Email
laleh_hassani@yahoo.com
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
Data is confidential.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available