Determining the effectiveness of multi-dimensional behavioral intervention program on HbA1c among patients with Type 2 diabetes
Design
This is a randomized trial with a control group, education based, parallel group, and without blinding. Randomization will be computerized with concealed randomization sequence. The patients will randomly be divided into control and intervention groups and a code will be allocated to them.
Settings and conduct
The study will be conducted in Khoy (West Azarbayjan, Iran) and diabetes care centers.
Participants/Inclusion and exclusion criteria
Patients with Type 2 diabetes/
Inclusion criteria: Having a registry profile in diabetes clinic of Khoy; Having consent to participant in the study.
exclusion criteria: having cognitive disorders
Intervention groups
A multi-dimensional behavioral intervention program according to social cognitive theory for decreasing HbA1c will be conducted. The educational program will include adherence to medicine, self-regulation, and self care among the patients. The intervention group will participate in educational sessions for 16 sessions during 60 minutes per week.
Main outcome variables
HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111119008132N7
Registration date:2018-04-15, 1397/01/26
Registration timing:retrospective
Last update:2018-04-15, 1397/01/26
Update count:0
Registration date
2018-04-15, 1397/01/26
Registrant information
Name
Leila Jahangiry
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 307 0128
Email address
jahangiry@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to assess the effectiveness of a Multi-dimensional Behavioral Intervention Program on decreasing HbA1C among patients with diabetes
Public title
The behavior intervention on control of glucose among diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a registry profile in diabetes clinic of Khoy
Having consent to participant in the study.
Exclusion criteria:
Having cognitive disorders
Age
From 30 days old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Diabetic patients referring to diabetes clinic will be recruited to the study through a simple randomization. Table of random numbers will be used to randomization. Random sequence generation and allocation concealment will be carried out independently by a researcher not connected to the study.
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
Ethic's comitte of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Golgasht street, Azadi Street, Tabriz, East Azarbayjan
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.TBZMED.REC.1396.192
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10-E14
ICD-10 code description
Endocrine, nutritional and metabolic diseases (E00-E90): Diabetes mellitus
Primary outcomes
1
Description
HBA1C
Timepoint
before intervention and after 24 weeks
Method of measurement
HbA1c Test
Secondary outcomes
1
Description
Adherence to medical care
Timepoint
2 and 6 month after intervention
Method of measurement
The adherence questionnaire for diabetic patients
Intervention groups
1
Description
Education behavior program about diabetes self-care will be conducted in the multi dimensions based on self-efficacy, self-control and self-regulation strategies among diabetic patients to modify self-care behaviors and decrease HbA1c. The intervention group will participate in such educational sessions about 60 minutes per week during 6 months.
Category
Behavior
2
Description
Control group: without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khoy Shahid Madani clinical care center
Full name of responsible person
Habibeh Matin
Street address
Shahid Madani Hospital, Valiasr Ave.,Khoy
City
Khoy
Province
West Azarbaijan
Postal code
5166614711
Phone
+98 41 3325 7580
Fax
Email
jahangiry@razi.tums.ac.ir
Web page address
http://healthfac.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Asghari
Street address
Tabriz University of Medical Sciences, Golgasht street, Azadi Steet, Tabriz Tabriz East Azarbayjan Iran, Islamic Republic Of
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3325 7580
Email
jahangiry@razi.tums.ac.ir
Web page address
http://healthfac.tbzmed.ac.ir/
Grant name
Vice Chancellor for research of Tabriz University of Medical Sciences
Grant code / Reference number
IR.TBZMED.REC.1395.1268.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Habibeh Matin
Position
Student
Latest degree
Master
Other areas of specialty/work
Public Health/Community Medicine
Street address
Health Education and Promotion departement, Public Health Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Fax
Email
habibehmatin@gmail.com
Web page address
http://healthfac.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. AndoReza Shaghaghi
Position
Assisstans Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Health Education and Promotion departement, Public Health Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 413357582
Fax
Email
ar.shaghaghi@gmail.com
Web page address
http://healthfac.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Jahangiry
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Health Education and Promotion departement, Public Health Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 413357582
Fax
Email
jahangiry@razi.tums.ac.ir
Web page address
http://healthfac.tbzmed.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
participant data sets are to be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
available for people working in academic institutions
Under which criteria data/document could be used
request from academic organization
From where data/document is obtainable
Health Education and Promotion department, Public Health Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi Street, Tabriz. Dr. Reza Shaghaghi
What processes are involved for a request to access data/document
sending request-assess the request by study responsible, and deliver the data