The aim of this study was to determine the effect of educational program based on the theory of self-regulation in increasing medication adherence in type II diabetic patients. Methods: This is an interventional study with two groups, pre-test and post-test will be performed on 120 patients with type II diabetes aged between 30 and 65 years, who meet in the home health records, consent to participate in the study and be able to participate Meetings and understanding, they will be carried out. Samples will be randomly drawn. Intervention (education based on the theory of self-regulation) will be conducted on case groups. A self-made questionnaire which its validity and reliability study to be checked before and 8 weeks after treatment, all samples will be answered.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121425518N1
Registration date:2015-12-29, 1394/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-29, 1394/10/08
Registrant information
Name
Behzad Gholamaliee
Name of organization / entity
Hamadan University of Medical Sciences, School of Public Health
Country
Iran (Islamic Republic of)
Phone
+98 81 3493 6012
Email address
b.gholamaleei@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research and Technology of the Hamadan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on self-regulation theory to increase medication adherence in Type 2 diabetic patients
Public title
The effect of education on medication adherence in patients with type II diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having health records in health center for control and treatment of diabetes, satisfaction from the study, diabetic patients are able to participate in training sessions and understand the training offered and aged between 30 to 65 years
Exclusion criteria: patients with diabetes who does not wish to continue participating in the study, Patients with diabetes who are not attending regular training sessions, Age less than 30 years and more than 65 years
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 the Hamadan University of Medical Sciences
Street address
Hamadan, Martyr Fahmideh Street, Hamadan University of Medical Sciences, School of Public Health
City
Hamadan
Postal code
65178
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.UMSHA.REC.1394.198
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
Medication Adherence
Timepoint
Before and one month after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control: no intervention
Category
N/A
2
Description
Intervention: medication adherence education based on self-regulation theory and the method Teach Back and Pictorial for 4 sessions for patients with type 2 diabetes.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Tuyserkan
Full name of responsible person
Behzad Gholamaliee
Street address
Hamadan, Martyr Fahmideh Street, Hamadan University of Medical Sciences, School of Public Health
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research and Technology of the Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashirian
Street address
Hamadan, Martyr Fahmideh Street, Hamadan University of Medical Sciences, Vice-Chancellor for Research and Technology
City
Hamadan
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 and Technology of the Hamadan 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
Hamadan University of Medical Sciences, School of Public Health
Full name of responsible person
Behzad Gholamaliee
Position
MSc student in Health Education
Other areas of specialty/work
Street address
Hamadan, Martyr Fahmideh Street, Hamadan University of Medical Sciences, School of Public Health