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The effect of educational intervention on perceptions, self-care and quality of life in patients with diabetes

Protocol summary

Summary
The purpose of this study is the effect of education intervention on knowledge, attitudes, self-care and quality of life in diabetes. This study is an interventional study. Participants will be selected from Diabetic patients. The main inclusion criteria patients with diabetes, lack of formal education about nutrition, exercise and self-care and consent to participate in the study and exclusion criteria include refusal for participation in the study, migration from the county of Chalderan and The died person time interval of the study. The sample size was obtained 37 persons for each group. After selecting the intervention and control groups, the data will be collected in two stages: The first phase of data collection will be before the intervention and the second stage 3 months after the intervention. Data will be collected using a questionnaire. In the stage before the intervention, the per-test will be done in both intervention and control groups ,and after analyzing the data, resources, limitation, needs, and strengths and weaknesses in different fields are identified , then type of content, teaching methods, time and the number of training sessions are designed tailored to the needs and desires. Outcomes of the study are knowledge, attitudes, self-care and quality of life in diabetic patients, before and after training.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015021015422N3
Registration date: 2015-03-14, 1393/12/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-03-14, 1393/12/23
Registrant information
Name
Towhid Babazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9118
Email address
t-babazadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-09-20, 1394/06/29
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of educational intervention on perceptions, self-care and quality of life in patients with diabetes
Public title
The effect of education on perceptions, self-care and quality of life in patients with diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with diabetes; lack of formal education about nutrition, exercise and self-care; consent to participate in the study Exclusion criteria: Refusal for participation in the study; Migration from Chalderan county; The died person time interval of the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
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
Tabriz University of Medical Sciences
Street address
Ethics Committee, Third Floor, Central Building 2, Tabriz University of Medical Science, Golgasht, Tabriz
City
Tabriz
Postal code
Approval date
2015-02-23, 1393/12/04
Ethics committee reference number
93183

Health conditions studied

1

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

Primary outcomes

1

Description
behavior
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Knowledge
Timepoint
Before the intervention and 3 months after interventio
Method of measurement
Questionnaire

2

Description
Attitude
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

3

Description
Self- care
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

4

Description
Quality of Life
Timepoint
Before the intervention and 3 months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
The Intervention group: In this study the intervention will be holding the training sessions. The intervention would be based on information obtained from the questionnaire.
Category
Behavior

2

Description
The control group: Training in control groups is not but after the end of data collection in the end of study, educational pamphlets will be given to the control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Chaldran Health Network
Full name of responsible person
Towhid Babazadeh
Street address
Chaldran Health Network, County Chaldoran, West Azerbaijan province
City
Chaldran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad-Reza Rashidi
Street address
Deputy for Research and Technology, Third Floor, Central Building 2, Tabriz University of Medical Sciences, Golgasht, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Towhid Babazadeh
Position
PhD student
Other areas of specialty/work
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7582
Fax
Email
towhid.babazadeh@live.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Towhid Babazadeh
Position
PhD student
Other areas of specialty/work
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7582
Fax
Email
towhid.babazadeh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Towhid Babazadeh
Position
PhD student
Other areas of specialty/work
Street address
Department of Health Promotion and Education, Faculty of Health and Nutrition, Golgashte Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7582
Fax
Email
towhid.babazadeh@gmail.com
Web page address

Sharing plan

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