Protocol summary

Summary
Objective: the effect of a learning style based education on metabolic control, quality of life and empowerment of patients with type 2 diabetes. Design: randomized clinical trial. Method: the study population:Patients with type 2 diabetes attending diabetes clinic of Shiraz Shahid Motahari clinic. Inclusion criteria: type 2 diabetes; tending to participate in research; ability to understand the content based on the researcher's judgment; not participating in similar educational classes in the past 6 months and reading and writing literacy. Exclusion criteria: unwillingness to continue participation in the study and stressful condition or surgery during the study. Sample size: 216. Intervention: after introducing the study and complete the consent form by patients researchers gather their basic information includes: Laboratory tests(FBS, HbA1C,Lipid profile) and questionnaires(demographic data, quality of life, empowerment and preferred learning style)then the patients are divided to 3 groups with block randomization technique(72 patients in each group):intervention 1, intervention 2 and control group.Patients in intervention 1 group will participate in multimodal educational class ( Combined teaching method of styles includes:visual, aural, read-write, and kinesthetic). Patients in intervention 2 group will participate in educational class based on their preferred learning style and patients in control group will participate in routine clinic classes. Three months after intervention laboratory tests, quality of life, and empowerment of all of the patients are re-assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201302222621N12
Registration date: 2013-06-06, 1392/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-06, 1392/03/16
Registrant information
Name
Marzieh Moattari
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4250
Email address
moattarm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-01-27, 1391/11/08
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a learning style based education on metabolic control, quality of life and empowerment of patients with type 2 diabetes
Public title
The effect of patient education on diabetes control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: type 2 diabetes; tending to participate in research; ability to understand the content based on the researcher's judgment; not participating in similar educational classes in the past 6 months and reading and writing literacy. Exclusion criteria: unwillingness to continue participation in the study and stressful condition or surgery during the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 216
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
Shiraz University of Medical Science
Street address
Shiraz University of Medical Science, Zand st
City
Shiraz
Postal code
Approval date
2013-01-26, 1391/11/07
Ethics committee reference number
CT-91-6428

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E10,E11
ICD-10 code description
Insulin-dependent diabetes mellitus, Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting Blood Sugar
Timepoint
Baseline and 3 months after intervention
Method of measurement
mg/dl

2

Description
Haemoglobin A1c
Timepoint
Baseline and 3 months after intervention
Method of measurement
percent

3

Description
tryglyceride
Timepoint
Baseline and 3 months after intervention
Method of measurement
mg/dl

4

Description
cholesterol
Timepoint
Baseline and 3 months after intervention
Method of measurement
mg/dl

5

Description
Low Density Lipoprotein
Timepoint
Baseline and 3 months after intervention
Method of measurement
mg/dl

6

Description
High Density Lipoprotein
Timepoint
Baseline and 3 months after intervention
Method of measurement
mg/dl

7

Description
empowerment
Timepoint
Baseline and 3 months after intervention
Method of measurement
michigan diabetes empowerment questionnaire

8

Description
quality of life
Timepoint
Baseline and 3 months after intervention
Method of measurement
Quality of Life Instrument for Indian Diabetes Patients (QOLID)

9

Description
Body Mass Index
Timepoint
Baseline and 3 months after intervention
Method of measurement
(height)2 /(weight)

Secondary outcomes

empty

Intervention groups

1

Description
Multimoda education Target group: intervention 1 group Numbers of participants in each calass: 12 This education program is a integration of styles includes: visual, aural, read-write, and kinesthetic Duration: 1 session
Category
Other

2

Description
Learning style based education Target group: intervention 2 group Numbers of participants in each calass: 12 Patients in this group participate in education class based on their preferred learning styles. Duration: 1 session
Category
Other

3

Description
Routine education program Target group: control Numbers of participants in each class: 12 The patients in this group participate in the lecturing routine class which is conducted in the clinic. Duration: 1 session
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes clinic of Shahid Motahari Clinic
Full name of responsible person
Dr. Marzieh Moattari
Street address
Diabetes clinic,Shahid Motahari Clinic, Namazi square
City
shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Scienses
Full name of responsible person
Dr. Marzieh Moattari
Position
PHD in Nursing, Faculty Member, Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Nursing College
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
moattarm@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Marzieh Moattari
Position
PhD of Nursing
Other areas of specialty/work
Street address
Shiraz Nursing College
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
moattarm@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Marzieh Moattari
Position
PhD of Nursing, Faculty member of Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Nursing College
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
moattarm@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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