Protocol summary

Study aim
Determining the effect of in-person training and educational booklet methods on adherence to the treatment regimen and health-related quality of life in patients with type 2 diabetes
Design
In this study, 120 patients with type 2 diabetes who are referred to the Diabetes Clinic and thus eligible to enter the study, are selected. Participants are randomly divided into three groups: in-person training, training with educational booket and control, and each participant is assigned a code.
Settings and conduct
The research population in this study is all patients with type 2 diabetes who referred to Jahrom Diabetes Clinic. The researcher identified the eligible diabetic patients and collected the information through demographic questionnaires health-related quality of life in diabetic patients, and the diabetic diet follow-up questionnaire by means of interviewing after getting their informed consent . The researcher interviewed three days a week and in the morning after the visit was completed. In the intervention phase, the same subjects were trained in the same way (in-imperson training and educational booklet), and the control group received the usual training in the clinic. In the post-intervention phase, two weeks after the pre-test, the questionnaire was re-submitted to the patients and the results was compared with the pre-test
Participants/Inclusion and exclusion criteria
inclusion criteria : definitive diagnosis of type 2 diabetes, at least diagnosis and treatment initiation for six months, minimum age 30.Conditions of exclusion criteria : Unwillingness to the continuation of study , visual impairment and hearing impairment
Intervention groups
In the intervention phase, researcher trained three groups the same subjects with different methods (in-person training and educational booklet) and the control group received the common training the clinic. Educational subjects include diabetes diagnosis, therapies, how to use drugs, insulin therapy, recommendations for the prevention of hypoglycemia and hyperglycemia, training for controlling blood glucose, exercise, etc. In the in-person training group, training time was considered to be 20 to 30 minutes. In the group that the members of it were trained by means of educational booklet, the same subjects were taught by means of simple and understandable pictures and texts. In the post-intervention phase, two weeks after the pre-test, the questionnaire was returned to the patients and the results were compared with the pre-test.
Main outcome variables
Adherence to Therapeutic Regimen and the improvement of the quality of life .

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171204037745N1
Registration date: 2018-02-16, 1396/11/27
Registration timing: retrospective

Last update: 2018-02-16, 1396/11/27
Update count: 0
Registration date
2018-02-16, 1396/11/27
Registrant information
Name
raziyeh rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 7301
Email address
r.rostami@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
2016-10-22, 1395/08/01
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
Comparison of Impact of In-person training and Educational Booklet Methods on Adherence to Therapeutic Regimen and Health-related Quality of Life in Patient with Type 2 Diabetes
Public title
"Effect of In-person training and Educational Booklet on Adherence to Therapeutic Regimen and Quality of Life in Diabetes"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The definitive diagnosis of type 2 diabetes The minimum diagnosis and initiation of treatment for type 2 diabetes for 6 months At least 30 years old The absence of diagnosed psychiatric disorders The ability to attend classes, and answering questions The possibility of follow-up after the intervention
Exclusion criteria:
Unwillingness to participate in the study Visual and auditory disorders
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Actual sample size reached: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Considering the number of groups studied, there were three groups. Thus, the size of each block is three ( three members in each block). In terms of number of blocks, the factorial rule is used, the number of blocks (6 × 1 × 2 × 6) is 6 blocks, the number of samples from blocks (with placement) to the number of samples was obtained.
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 Yasuj University of Medical Sciences
Street address
Yasuj-Boulevard, Shahid Motahari-Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2016-07-02, 1395/04/12
Ethics committee reference number
IR.YUMS.REC.1395.10

Health conditions studied

1

Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
adherence to therapeutic regimen
Timepoint
At the beginning of the study and 14 days after the intervention
Method of measurement
adherence to therapeutic regimen Questionnaire

2

Description
health-related quality of life
Timepoint
At the beginning of the study and 14 days later
Method of measurement
health-related quality of life questionnaire in patients with type 2 diabetes

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the case study group, training was considered for 20 to 30 minutes. The content of 3 sessions that was conducted for the patients in the face-to-face training group is as follows: Description of diabetes disease, treatments, how to use drugs, insulin therapy, recommendations for the prevention of hypoglycemia and hyperglycemia, training for blood glucose control, exercise.
Category
Other

2

Description
Intervention group: educational booklet: In the educational booklet group, the same subjects as in-person training group were taught using simple and understandable pictures and texts.
Category
Other

3

Description
Control group: The control group received the usual training in the clinic. the standard training includes the training related to diet , medication use and the use of insulin that patients receive at the doctor's office.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Jahrom city
Full name of responsible person
Raziyeh Taheri
Street address
Imam Ali Street
City
Jahrom
Province
Fars
Postal code
7415113465
Phone
+98 71 5446 0455
Email
r.rostami@jums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Vice chancellor of research and technology
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 6078
Email
r.rostami@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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

2

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Vice chancellor of research and technology
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 6078
Email
r.rostami@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Raziyeh Taheri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Fax
Email
r.rostami@jums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Raziyeh Taheri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Fax
Email
r.rostami@jums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Raziyeh Taheri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
rrostami@jums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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