The aim of the study is to compare the effect of group education and group counseling on self-care in patients with Type II diabetes . Inclusion criteria are patients 18 to 60 years old that last six months of diagnosis of diabetes. Exclusion criteria is participants who absent in more than a counseling or education session. Total of 110 diabetic patients randomly allocated into three groups. contro group has no education but intervention group 1, group education and intervention group 2, group counseling perform. counseling and education perform in 5 to 7 sessions of 1 to 1.5 hours. The primary outcome measures includ self-care and HbA1c. Primary outcome time points are beginning of the study and two months after intervention And Primary outcome method of measurement are Researcher made questionnaire Self Care and HBA1C Test. Primary outcome measures, time points and method of measurements is similar in three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122220394N1
Registration date:2015-01-13, 1393/10/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-13, 1393/10/23
Registrant information
Name
Mahbobeh Firooz
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 2650
Email address
mahbobehfirooz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2014-06-28, 1393/04/07
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of the effect of group education versus group counseling on self care of patient with diabetes type II
Public title
Comparsion of the group education versus group counseling on self care of patient with diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
Including criteria: The last six months of diagnosis of diabetes; age 18 to 60 years. Exclusion criteria: Participants who absent in more than a counseling or education session
Age
From 75 years old to 33 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
110
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St. Doktora Crossroads.
City
Mashhad
Postal code
Approval date
2014-06-28, 1393/04/07
Ethics committee reference number
922652
Health conditions studied
1
Description of health condition studied
diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Self Care
Timepoint
Beginning of the study, two months after intervention
Method of measurement
Researcher made questionnaire Self Care
2
Description
HbA1c
Timepoint
Beginning of the study, two months after intervention
Method of measurement
HbA1c test
Secondary outcomes
empty
Intervention groups
1
Description
This was a 3-group randomized interventional trial. control group (without education) ): Includs patient with diabetes type II; interventions includ: pretest( Researcher made questionnaire Self Care and HbA1c test); post tests include: two months after intervention.
Category
N/A
2
Description
intervention group1: patient with diabetes type II; interventions includ: pretest( Researcher made questionnaire Self Care and HbA1c test), Attend in a 5 to 7 sessions of 1 to 1.5 hours group Educational about Self Care; post test two months after intervention.
Category
Prevention
3
Description
intervention group2 : patient with diabetes type II; interventions includ: pretest( Researcher made questionnaire Self Care and HbA1c test), Attend in a 5 to 7 sessions of 1 to 1.5 hours group counseling about Self Care; post test two months after intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Parsian Diabetes Clinic
Full name of responsible person
Ali Akbar Raof
Street address
Shahid Chamran St, Chamran 8 Ave.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossing
City
Mashhad
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, Mashhad 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
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Mahbobeh Firooz
Position
MS Nursing/Postgraduate student
Other areas of specialty/work
Street address
Ebn-e Sina St, Doktora Crossing
City
Mashhad
Postal code
Phone
+98 58 3723 2650
Fax
Email
firoozm911@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Seyed Reza Mazlom
Position
PhD
Other areas of specialty/work
Street address
Ebn-e Sina St, Doktora Crossing, Daneshgah Ave.
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
mazlomr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Mahbobeh Firooz
Position
MS Nursing/Postgraduate student
Other areas of specialty/work
Street address
Ebn-e Sina St, Doktora Crossing, Daneshgah Ave.
City
Mashhad
Postal code
Phone
+98 58 3723 2650
Fax
Email
firoozm911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)