Protocol summary

Summary
The aim of this study was to determine the effect of education based on Vark learning style in self_care of patients with type II diabete. The study included 70 patients with type II diabete reffered to clinic "Parsian" in Mashhad, Iran. All participants had taken written consent. First of all, the degree of self_care level is determined in both itervention and control groups by using a questionnaire following the treatment regimen in patients with Type II diabetes And also learning style of intervention group was determined by using Vark learning style questionnaire, in continue learners in Vark approach, based on exchange ways and responding to the environment, was devided into four categories: visual, auditory, reading / writing and a movement / motion. In the intervention group each person, based on their learning style within the group, had received the necessary training of self-care. Also in the control group the patients received self-care educational content (including physical activity, nutrition, drug regimen, glycemic control) like to diabetes clinic (face to face teaching and learning). Training in the control group as well as intervention groups was provided in two 2-hour sessions (one session for both areas). In both intervention and control groups a self _care questionnaire is provided to each patient at the end of the second training session. Also one month after intervention, patients completed the self_caring questionnaire again and were measured their HbA1c levels and fasting blood glucose levels.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121025470N1
Registration date: 2016-08-03, 1395/05/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-03, 1395/05/13
Registrant information
Name
Farzane Hozhabr Araghi
Name of organization / entity
Mashhad university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 933 135 3335
Email address
hozhabrf921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad 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
Designation the effect of education earning style on self-care in patients with Non-insulin-dependent diabetes
Public title
The effect of education earning style on self-care in patients with Type II diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: literacy; signing informed consent to participate in research; age between 65-18 years old; the amount of glycosylated hemoglobin between 7 to 9 percent; fasting blood sugar is between 140 and 250 mg. People having the following items will be excluded from the study: shunning to continue participating in research; traveling or hospitalizing; if being absent in one of the training sessions.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Ghoraishy Building, University St., Mashhad
City
Mashhad
Postal code
Approval date
2016-01-27, 1394/11/07
Ethics committee reference number
IR.Mums.REC.1394.970

Health conditions studied

1

Description of health condition studied
Type II diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Self-Care
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
Questionnaire follow the treatment regimen in patients with type II diabetes

Secondary outcomes

1

Description
HbA1c and fasting blood sugar
Timepoint
Before and one month after intervention
Method of measurement
Biosystems kit for measuring glycated hemoglobin and parsazmun test glucose kit to measure blood glucose hexokinase method

Intervention groups

1

Description
In the intervention group each person, based on their learning style within the group, had received the necessary training of self-care. learners in Vark approach, based on exchange ways and responding to the environment, was devided into four categories: visual, auditory, reading / writing and a movement / motion.
Category
Other

2

Description
in the control group the patients received self-care educational content (including physical activity, nutrition, drug regimen, glycemic control) like to diabetes clinic (face to face teaching and learning).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Parsian Diabetes Clinic
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saieed Eslami
Street address
Vice Chancellor for research, Mashhad University of Medical Sciences, Ghoraishy Building, University St., Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amir Reza Salehi Moghadam
Position
MSc/ Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
9137913199
Phone
+98 915 110 6539
Fax
+98 51 3859 7313
Email
SalehmoghaddamAR@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Reza Salehi Moghadam
Position
MSc/ Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
9137913199
Phone
+98 915 110 6539
Fax
+98 51 3859 7313
Email
Salehmoghaddamar@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad Nursing and Midwifery School
Full name of responsible person
Farzane Hozhabr Araghi
Position
MSc student of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
Phone
Fax
+98 51 3859 7313
Email
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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