The aim of this study is to determine the efficacy of a self-care package on glycemic control and self-efficacy, which has been prepared for diabetic pregnant women. In this experimental study, a control group and an intervention group (70 persons in each group) will participate. The criteria to take part in the study include: being pregnant, having diabetes confirmed by reliable tests according to the Health Ministry guideline, being literate (able to read and write in Persian), being able to answer the related questionnaire independently and sign the consent letter, having no visual or hearing impairment or mental illnesses which needs medication or psychiatrist continuous care, and having no previous experience of participation in any diabetes self-management training programs. To randomize, block randomization method is used. The control group uses routine educational programs and the intervention group is trained according to the confirmed educational curriculum. Three training sessions will be held every week in the Diabetes Center by applying group training method. A comparison of glycemic control will be done between the two groups before and after the intervention. Long-term outcomes include delivering outcomes such as birth weight, Apgar, method of delivery and neonatal admission. Self-efficacy will also be determined by “Stanford Scale for Self-Efficacy in Diabetic Patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102824753N1
Registration date:2016-01-09, 1394/10/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-09, 1394/10/19
Registrant information
Name
Mitra Kolivand
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 9980
Email address
mitrakolivand@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Budget of PhD Thesis
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effectiveness of self-care package in pregnant diabetic women
Public title
The Effectiveness of self-care package on glycemic control and self efficacy in pregnant diabetic Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being pregnant; having diabetes (gestational or overt) confirmed by reliable tests according to the Health Ministry guideline; being able to read and write in Persian; being able to answer the questionnaire independently and sign the consent letter; having no visual or hearing impairment or mental illnesses which needs medication or psychiatrist continuous care; and having no previous experience of participation in any diabetes self care training programs; not being addicted to alcohol; cigarette or drugs; gestational diabetes has been diagnosed not more than a month; gestational age should not be more than 28 weeks; the patient should not experience any intensive stressful events during the study.
Exclusion criteria: refusing from cooperation in the study; being absent for two or more educational sessions; occurrence of high-risk pregnancy complications such as vaginal bleeding; preeclampsia; preterm labor; admission in hospital due to any reason; multiple pregnancy; the patient should not be a member of medical and paramedical staff.
Age
From 14 years old to 49 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To randomize, block randomization method is used.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, HafteTirSquare, Shahroud, IRAN
baseline (pre-intervention) and one month after intervention
Method of measurement
by use of self-efficacy questionare of Stanford University
2
Description
blood sugar
Timepoint
baseline (pre-intervention) and one month after intervention
Method of measurement
level of fast blood sugar,and 2 hour post prandial
Secondary outcomes
1
Description
maternal and neonatal results
Timepoint
in and after delivery
Method of measurement
Determining Apgar score, neonatal birth weight, method of delivery and neonatal admission
Intervention groups
1
Description
Intervention group will be trained based on an approved schedule and curriculum which is the result of a qualitative study with nominal group. Intervention can be as follows: educational program is delivered within six training sessions which are held every five days in the diabetes center. Training method will be group work. At most, eight pregnant women will participate in each session.Training include: face to face education by the use of slideshows, movie and an educational package in the form of a book. Insulin injection is taught by using a human body moulage. Relaxation training and appropriate pregnancy exercises will be taught to reduce stress in the participants in one session. Regarding the related topics, different methods of giving lecture, having a question-and-answer session and group discussion will be used. All the topics will be done by a trained researcher, and if necessary the patients is referred to a specialist (nutritionist, endocrinologist…). To becommitted to Supportive Self- Management Education (SSME), we consider a contact number for patients. Definitive component of intervention will be determined after the second stage of the researcher’s Thesis.
Category
Behavior
2
Description
The Control group will be received routine care of Clinic.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic and Research Center of Diabetes
Full name of responsible person
Dr.MehrAli Rahimi
Street address
Clinic and Research Center of Diabetes of Kermanshah University of Medical Sciences, Kermanshah, IRAN Islamic Republic Of
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr Mehr Ali, Rahimi
Street address
Naft square, Kermanshah University of Medical Sciences, Kermanshah, IRAN
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mitra Kolivand
Position
Student of Reproductive Health-PHD Degree
Other areas of specialty/work
Street address
HafteTir Square, Faculty of Nursing and Midwifery, Shahroud, IRAN Islamic Repub Of