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The effect of therapy on glycemic control, anxiety and depression in adolescents with type I diabetes.

Protocol summary

Summary
Scientific : The effect of therapy on glycemic control, anxiety and depression in adolescents with type I diabetes. Setting and conduct: Clinical Trial, a randomized, Phase 3-2 clinical trials. Intervention: This randomized clinical trial study was conducted on 74 adolescents with type I diabetes with age of 11-24 years on Ahvaz Golestan and Abuzar hospitals, Iran, in 2014. Patients were assigned to 3 intervention group (n= 12 in first and second group and n= 13 in third group) and control group (n= 37) randomly. Matches of the patients in both groups were done related to age, sex, education, ethnicity, diabetes duration and family history as well as parents’ income. Data was collected by demographic and clinical characteristics checklists and Beck anxiety and depression inventory. At the first and before the intervention, patients’ educational and supportive needs were assessed during an interview, and then patients in both groups filled out the questionnaires. Also, Fasting Blood Sugar (FBS) and HbA1C were tested before the study with glucometer and calorimetry laboratory test respectively by a laboratory technician in both studied groups. Patients in 3 intervention group were educated with group discussion in one section (2 hours) in a week during 2 months. Patients in control group received no intervention and was emphasized that participate in no educational programs until the end of the studyAfter ending the intervention, patients were followed for 3 months with telephone

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014092419284N1
Registration date: 2014-11-19, 1393/08/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-19, 1393/08/28
Registrant information
Name
Marjan Naseri
Name of organization / entity
University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 614435890
Email address
naseri.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Ahvaz University of Medical Sciences
Expected recruitment start date
2014-07-25, 1393/05/03
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of therapy on glycemic control, anxiety and depression in adolescents with type I diabetes.
Public title
Effect of training on blood glucose control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having 21-11 years of age; In ahvaz Location; Disease for at least 6 months; Lack of training and support so far Group; No Uncontrolled underlying disease such as epilepsy, etc; Lack of long-term complications of diabetes (retinopathy, nephropathy, neuropathy); Inclination To participate in training programs; Lack of diseases that affect measur HbA1C levels (eg, anemia, haemoglobinopathy, uremia, renal failure and hemodialysis); No History of anxiety and depression and other mental illness diabetes before. Exclusion criteria: Psychotropic drugs and psychiatric treatment or substance abuse during the study; Hospitalization during the period of study.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
--
Secondary trial Id
--
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan.
City
Ahvaz
Postal code
00986135715794
Approval date
2014-06-28, 1393/04/07
Ethics committee reference number
1393.117

Health conditions studied

1

Description of health condition studied
Type 1 Diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Anxiety
Timepoint
Before and three months after intervention.
Method of measurement
Beck Anxiety Inventory

2

Description
Fasting blood sugar
Timepoint
Before and three months after intervention.
Method of measurement
Its scales mg / dl with blood tests taken

3

Description
Glycosylated hemoglobin
Timepoint
Before and three months after intervention.
Method of measurement
Scale is the percentage of blood samples taken

4

Description
Depression
Timepoint
Before and three months after intervention.
Method of measurement
Beck Depression Inventory

Secondary outcomes

1

Description
Group Education
Timepoint
With intervention, training, and three months later to be weighed
Method of measurement
Inventory and FBS-HbA1C test

Intervention groups

1

Description
Experimental trial to evaluate training to determine the impact on glycemic control in diabetic adolescents with anxiety and depression made, Its effectiveness is measured three months later Before and after training to assess FBS-HbA1C blood test taken.
Category
Lifestyle

2

Description
The control group consisted of taking blood tests to check for interferences and FBS-HbA1C during the study did not receive the intervention, After three months, the group will be re-tested.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr.Ryahy
Street address
Golestan hospital, Golestan road, Ahvaz, Khozestan
City
Ahvaz

2

Recruitment center
Name of recruitment center
Aboozar Hospital
Full name of responsible person
Dr.Ryahy
Street address
Aboozar Hospital , Ave Nurse,Blvarpasdaran, Circle Shhydbndr, Ahvaz, Khuzestan.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Ahmad Hosseini
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan.
City
Ahvaz
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 Ahvaz 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
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Marjan Naseri
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
-
Phone
+98 614435890
Fax
-
Email
naseri.ma@ajums.ac.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Doctor Rostami
Position
P H D
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
61357-15794
Phone
+98 613738399
Fax
-
Email
Rostami-sh@ajums.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Marjan Naseri
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
-
Phone
+98 614435890
Fax
-
Email
naseri.ma@ajums.ac.ir
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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