Comparison of the effectiveness of education based on the participation of spouses on social support and treatment compliance in women with gestational diabetes mellitus in two groups of control and intervention
Determining the Impact of Education Based on Spouse's Participation in Social Protection and Adherence to Treatment in Women with Gestational Diabetes
Design
Clinical trial with randomized control group، Sample size 80
Settings and conduct
The place of research is the Bahar Hospital affiliated to Shahrud University of Medical Sciences.
The intervention program will be held in two individual sessions. Also, participants in the test group will receive a training message through the social telegram or WhatsApp on a daily basis, and once a week, feedback from the couples will be provided by telephone follow-up.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of gestational diabetes
Being treated and controlled by diet, oral medication, or insulin.
Couples aged 18 and over
Couples have the ability to read and write
Couples aged 18 and over
Couples have the ability to read and write.
Single pregnancy pregnancy without abnormalities
primary par
Pregnancy is between 20-30 weeks.
Pregnancy is requested by couples.
Couples have a mobile phone with Android OS or ios.
Exclusion criteria:
Have a preterm delivery.
Spouse's separation or death during the study.
Unwillingness to continue the presence of couples in intervention sessions
The absence of couples even at a training session
Failure to study messages by couples
Intervention groups
Women with gestational diabetes Mellitus in the control group who have no intervention. And women with gestational diabetes in the intervention group, who, together with their husbands, undergo two sessions of in-service training and continue through public media along with their husbands.
Main outcome variables
Adherence to social support treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180613040086N1
Registration date:2018-09-26, 1397/07/04
Registration timing:registered_while_recruiting
Last update:2018-09-26, 1397/07/04
Update count:0
Registration date
2018-09-26, 1397/07/04
Registrant information
Name
Maryam Abdollahian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
abdollahian.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-21, 1397/05/30
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of education based on the participation of spouses on social support and treatment compliance in women with gestational diabetes mellitus in two groups of control and intervention
Public title
Impact of education based on spouses on Social support and Treatment adherence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of gestational diabetes in a patient's case is documented by a physician
Being treated and controlled by diet, oral medication, or insulin
Couples aged 18 and over
Couples have the ability to read and write.
Couples do not have chronic psychiatric and neurological diseases that disrupt consciousness and disturbance in the movement of the person, such as severe stroke, dementia and spinal cord injury. Also, they do not have visual hearing impairment
Single pregnancy without abnormalities
primary parous women
Pregnancy is between 20-30 weeks
Pregnancy is requested by couples.
Couples have a mobile phone with Android OS or ios
Exclusion criteria:
Preterm labor
divorce or death of a spouse during the study
Unwillingness to continue the presence of couples in intervention sessions (2 in-person meetings and continued meetings with public outlets and follow-up)
The absence of couples even at one training session
Failure to read the messages in the Telegram Whats App by couples and the lack of telephone answering by couples in telephone follow-ups.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization not done
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 Iran University of Medical Sciences
Street address
خیابان ولی عصر (عج)، بالاتر از میدان ونک، خیابان رشید یاسمی
City
tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Approval date
2018-05-14, 1397/02/24
Ethics committee reference number
IR.IUMS.REC.1396.9511686004 IR.IUMS. FMD.REC :
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.41
ICD-10 code description
Gestational diabetes mellitus in pregnancy
Primary outcomes
1
Description
social support
Timepoint
4 weeks After the first intervention session
Method of measurement
Social support questionnaire in diabetic patients
Secondary outcomes
1
Description
Adherence to treatment
Timepoint
4 weeks After the first training session
Method of measurement
Compliance questionnaire from treatment
Intervention groups
1
Description
Intervention group: Pregnant women and their wives will be placed under a two-part training session and the remainder will be available for four weeks through the public media.
Category
Prevention
2
Description
Control group: No intervention program will be performed
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahroud University of Medical Sciences, Bahar Hospital
Full name of responsible person
maryam abdollahian
Street address
Shahrud. Avenue 22 Bahman Bahar Hospital
City
shahrud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3222 4091
Fax
+98 23 3222 7607
Email
info@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Abdollahian
Street address
Valiasr Ave (Aj), above Vanak Square, Rashid Yasemi Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8888 2885
Fax
+98 21 8820 1978
Email
fnm@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mansoureh Ashgholi Farahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr Ave, above Vanak Square, Rashid Yasemi Street Faculty of Nursing and Midwifery of Iran
City
tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
maryamabdollahian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mansoureh Ashgholi Farahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Valiasr Ave, above Vanak Square, Rashid Yasemi Street
City
tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8888 2886
Email
fnm@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
maryam abdollahian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Ave, above Vanak Square, Rashid Yasemi Street
City
tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8888 2886
Email
fnm@iums.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
I'll publish it as needed
When the data will become available and for how long
20 day
To whom data/document is available
I'll publish it as needed
Under which criteria data/document could be used
I'll publish it as needed
From where data/document is obtainable
Responsible person
What processes are involved for a request to access data/document