This study is a randomized clinical trial study in 2016 to comparison the effect of two messages frame, gain frame or loss frame on knowledge, self-efficacy and diabetic self-care in patients with type 2 diabetes. Inclusion criteria: Having diabetes for six months or more, Covered by diabetes control center, Having the ability to read and write and Exclusion criteria: unwillingness to participate in the study, Not gestational diabetes.
The population of study includes Patients suffering from diabetes will be recruited from the 17 Shahrivar Diabetes Clinics in Borazgan through a simple randomized sampling procedure and a sample size of 126. In this study, 126 eligible patients will be categorized in 3 groups; one group will receive educational booklet with gain-frame messages (N=42); another group will receive educational booklet with loss-frame messages (N=42) and control group will receives routine clinical education (N=42). The patients in three groups will complete the questionnaires in three different intervals, before, one week and three months after training. The outcome of this intervention is Commitment to perform self-care behaviors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122931653N1
Registration date:2017-01-16, 1395/10/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-16, 1395/10/27
Registrant information
Name
Elahe Afrazeh
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3483 3272
Email address
e.afrazeh@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Bushehr University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two messages frame, gain frame or loss frame on knowledge; self-efficacy and self-care in patients with type 2 diabetes
Public title
The Comparison the effect of messages frame on knowledge; self-efficacy and self-care in diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Having diabetes for six months or more, Covered by diabetes control center, Having the ability to read and write. Exclusion criteria: unwillingness to participate in the study, Not gestational diabetes.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients will be categorized in three groups by random allocation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Science
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani
City
Bushehr
Postal code
7514633341
Approval date
2016-12-19, 1395/09/29
Ethics committee reference number
IR.BPUMS.REC.1395.129
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Self-care in diabetes
Timepoint
Before, a week and three months after education
Method of measurement
Questionnaire
2
Description
Self-efficacy in diabetes
Timepoint
Before, a week and three months after education
Method of measurement
Questionnaire
3
Description
knowledge in diabetes
Timepoint
Before, a week and three months after education
Method of measurement
Questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
The patients in intervention group will receive gain frame messages about knowledge, self-efficacy and diabetic self-care through booklet.
Category
Prevention
2
Description
The patients in another intervention group will receive loss frame messages about knowledge, self-efficacy and diabetic self-care through booklet.
Category
Prevention
3
Description
The patients in control group will receive routine clinical education.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Diabetes Clinic
Full name of responsible person
Jamileh Moarefi
Street address
17 Shahrivar Diabetes Clinic, Hospital Street.
City
Borazjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Bushehr University of Medical Sciences
Full name of responsible person
Afshin Ostovar
Street address
Bushehr University of Medical Sciences, Salman Farsi St, Bahmani, Bushehr, Iran
City
Bushehr
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 of Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Azita Noroozi
Position
Ph.D. of Health Education and Health Promotion
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani
City
Bushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
azitanoroozi@yahoo.com
Web page address
www.bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Azita Noroozi
Position
Ph.D. of Health Education and Health Promotion
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani
City
Bushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
azitanoroozi@yahoo.com
Web page address
www.bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Elahe Afrazeh
Position
MSc Student of Health Education
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani
City
Bushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
+98 77 3332 3123
Email
67.elahe@gmail.come.afrazeh@bpums.ac.ir
Web page address
www.bpums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)