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The effect of family-centered care on self-care in mothers with gestational diabetes

Protocol summary

Study aim
Investigating the effect of family-centered care on glycemic index and self-care in mothers with gestational diabetes
Design
Randomized clinical trial with parallel groups on 46 patients in the intervention group (23 people) and the control group (23 people)
Settings and conduct
In mothers with gestational diabetes under the coverage of Southern comprehensive health centers affiliated to Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
The inclusion criteria of pregnant mothers include: gestational diabetes, 24 to 28 weeks of pregnancy, minimum literacy to read and write, Willingness to participate in the study, The exclusion criteria include: vision and hearing impairment, suffering from chronic physical or mental diseases, alcohol or drug addiction, participation in other self-care training programs, unwillingness to continue participating in the research, acute illness during the study, divorce, accident, relocation, lack of access to samples, and premature birth. The inclusion criteria for an active family member include: minimum age of 18 years and maximum of 60 years, having minimum literacy to read and write, willingness to participate in empowerment sessions and accompany the patient, not participating in similar empowerment classes and courses, a key person in the patient's life and living with the patient and being a member of the patient's family, The exclusion criteria include: unwillingness to continue participating in the research and the occurrence of an acute event in which the person is unable to continue cooperation.
Intervention groups
In the intervention group, in order to empower the family in each of the axes of family-centered care measures will be taken.
Main outcome variables
self-care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230203057312N1
Registration date: 2023-02-26, 1401/12/07
Registration timing: prospective

Last update: 2023-02-26, 1401/12/07
Update count: 0
Registration date
2023-02-26, 1401/12/07
Registrant information
Name
Sahar Mohseni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4414 1699
Email address
mohsenis@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered care on self-care in mothers with gestational diabetes
Public title
The effect of family-centered care on self-care in mothers with gestational diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria for the study of pregnant mothers include: gestational diabetes (based on fasting blood sugar and oral glucose tolerance test) 24 to 28 weeks of pregnancy Having minimum literacy to read and write Willingness to participate in the study The inclusion criteria for an active family member include: minimum age of 18 years and maximum of 60 years having minimum literacy to read and write willingness to participate in empowerment sessions and accompany the patient not participating in similar empowerment classes and courses a key person in the patient's life (according to the patient's statements) and living with the patient and being a member of the patient's family (spouse, parents, children, siblings)
Exclusion criteria:
The failure to enter criteria for a pregnant mother include: vision and hearing impairment suffering from chronic physical or mental diseases alcohol or drug addiction participation in other self-care training programs The exclusion criteria of a pregnant mother include: unwillingness to continue participating in the research acute illness during the study divorce accident relocation lack of access to samples premature birth The exclusion criteria of an active family member include: unwillingness to continue participating in the research and the occurrence of an acute event in which the person is unable to continue cooperation.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple random method, the samples will be randomly assigned to two intervention and control groups based on the Randomizer.org website. The random allocation will be hidden by using sealed opaque envelopes so that the name of the intervention or control group will be placed in the opaque envelopes, and an envelope will be randomly assigned to each person included in the study and the grouping status of people will be determined.
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 in Research Faculty of Nursing and Midwifery and Faculty of Rehabilitation - Tehran
Street address
No1. Corner of Mikhak Alley. Rahmani St. Moradi St. Shahreziba St.
City
Tehran
Province
Tehran
Postal code
1484999648
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.TUMS.FNM.REC.1401.152

Health conditions studied

1

Description of health condition studied
gestational diabetes
ICD-10 code
O24
ICD-10 code description
Diabetes mellitus in pregnancy

Primary outcomes

1

Description
self-care
Timepoint
The beginning of the study and 3 months after that
Method of measurement
Standard self-report tool of self-care in patients with diabetes (SCODI)

Secondary outcomes

1

Description
glycemic index
Timepoint
The beginning of the study and 3 months after that
Method of measurement
Oral glucose tolerance test

Intervention groups

1

Description
Intervention group: In the intervention group, in order to empower the family in each of the axes of family-centered care (maintaining respect, sharing information, participation of patients and families in care, creating a basis for the cooperation of patients, families, health care providers in planning , implementation and evaluation of care) actions will be taken.
Category
Lifestyle

2

Description
Control group: In the control group, only the common care and education during pregnancy will take place. People belonging to the control group will receive the training that is usually provided during pregnancy through the Southern Comprehensive Health Centers affiliated to Tehran University of Medical Sciences in the form of face-to-face classes and educational pamphlets.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
South Comprehensive Health Centers affiliated with Tehran University of Medical Sciences
Full name of responsible person
Dr.Sarieh Poortaghi
Street address
Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
S-Poortaghi@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Sarieh Poortaghi
Street address
Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
S-Poortaghi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr.Sarieh Poortaghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
S-Poortaghi@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Sarieh Poortaghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Email
S-Poortaghi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sahar Mohseni
Position
Master student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No1. Corner of Mikhak Alley. Rahmani St. Moradi St. Shahreziba St.
City
Tehran
Province
Tehran
Postal code
1484999648
Phone
+98 919 270 0040
Email
mohsenis@razi.tums.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
-
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
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