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The effect of educational intervention on management of Blood Glucose and Confidence in Self-Care in patients with type 2 Diabetes by using face to face training and educational film: A randomised controlled clinical trial

Protocol summary

Summary
(1) Objectives: The effect of educational intervention on management of Blood Glucose and Confidence in Self-Care in patients with type 2 Diabetes by using face to face training and educational film. (2) Design: This study is a randomized clinical trial with two groups (intervention and control). 192 samples were determined according to the same studies. In this clinical trial, two groups, intervention and control groups will be randomly selected. Ones, with the film and to another one face to face training, in groups with 4-5 people, all required training will be given. The control group, will receive routinely training methods of Diabetes Center. Diary blood sugar, and Confidence in Self-Care Questionnaires, one week before and one month after intervention patients to be complete. And also, the amount of Glycated Hemoglobin in the last tests before and three months after the intervention will be recorded. (4) Participants: Patients with diabetes who inject Insulin themselves and Which have files in Diabetes Association. (5) Intervention: Interventions will be as training to patients. Interventions as training to patients, according to the educational content will take place. Before intervention and one month after the last training session, daily Blood Glucose diary and Confidence in Self-care Questionnaire will completed. For the control group, just Confidence in Self-Care Questionnaire and record sheet daily Blood Glucose, with time intervals similar to the experimental groups will be completed. (6) Main outcome measures variables: Average daily Blood Glucose, Confidence in Self-Care Questionnaire score and the amount of Glycated Hemoglobin

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016082412264N4
Registration date: 2016-10-20, 1395/07/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-20, 1395/07/29
Registrant information
Name
Farahnaz Abdollahzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 0648
Email address
abdollahzadehf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
research deputy of Tabriz university of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention on management of Blood Glucose and Confidence in Self-Care in patients with type 2 Diabetes by using face to face training and educational film: A randomised controlled clinical trial
Public title
The effect of educational intervention on management of Blood Glucose and Confidence in Self-Care in patients with type 2 Diabetes by using face to face training and educational film: A randomised controlled clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria : The patient has primary education is minimal; The patient is a resident of Tabriz; The patient's age is between 40 and 70; Patients are under insulin treatment; The patient is not suffering from mental illness; The patient is willing to participate in the study; The patient has recently joined to Diabetes Society. Exclusion criteria: membership one of the family members in health care team; patient's absence from training sessions; infection or having surgery.
Age
From 40 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 192
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: In this study, type of interventions order will be determined based on random numbers and the invisible envelope will be recorded. Whenever the number of new members (registered) reached twenty, a parcel (by the secretary of the center) is removed and it will be determined according to the type of intervention. Interventions presenter, will not be notified orders of packets until classes start time to assign people randomly occur. When Face-to-face group or Movie group terms arrive People will have determined with the numbers one to twenty. Then people with drawing, will dividing into four group with five members.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of medical sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
5138947977
Approval date
2016-09-10, 1395/06/20
Ethics committee reference number
We're getting license

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Average daily blood sugar
Timepoint
One week before intervention and one month after intervention for a week
Method of measurement
By using Beurer Glucometer

2

Description
Confidence in Self-Care
Timepoint
One week before intervention and one month after intervention for a week
Method of measurement
Confidence in Self-Care Questionnaire

Secondary outcomes

1

Description
Glycosylated hemoglobin
Timepoint
The last test before the intervention and after the intervention first test
Method of measurement
By using Glycated Hemoglobin detection kit

Intervention groups

1

Description
Intervention 1: Intervention in face to face training group will take place by using equipment needed by the researcher. in a 30-minute session, as a group (4-5 people) in the Diabetes Association, quiet and equipped with teaching aids, and researcher entire process with a glucometer, Flex Penn and correct principles of using and Insulin injections on models and practically will train and at the end of the session, the patients are given enough time for questions and answers and practical training.
Category
Prevention

2

Description
Intervention 2: In groups of videos, tutorials in terms of screening to patients, in groups (4-5 Members) will be provided. A film that is 22 minutes of Tutorials Video Film of Pars NovoNordisk company, Beuerr company and Aparat website. Content of this group with content of face to face training group are matches. Researcher by using film, all the content in a simple language and native participants will explain to patients. Watch Tutorials Video Film in place of quiet Diabetes Association and will be equipped with audio-visual equipment’s. At the end of the session, patients are given enough time for questions and answers. Researcher will explain all the content in a simple language and native participants by using film, to patients. Play backing will be in Diabetes Association that is quiet place and equipped with audio-visual equipment’s. At the end of the session the patient enough time for questions and answers will be given
Category
Lifestyle

3

Description
Intervention 3: In the control group, the patients will receive Routine training of the center that is lectures. Researcher will be presented, the previous educational content, in the form of lectures as a groups with 30 minutes’ time length. Lecture will take place in a peaceful environment in the Diabetes Association and at the end of the session, patients are given enough time for questions and answers.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Association of East Azarbaijan
Full name of responsible person
Doctor Majid Mobasseri
Street address
Fatmy 24 meters, North Gatran Avenue, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research Deputy in Tabriz University of Medical Sciences
Full name of responsible person
Doctor Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Golgasht Avenue.
City
Tabriz
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 Deputy in 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
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences.
Full name of responsible person
Farahnaz Abdollahzadeh
Position
Masters of Sciences
Other areas of specialty/work
Street address
Kosar Dormitory, Shariati Avenue.
City
Tabriz
Postal code
Phone
+98 41 3479 6707
Fax
Email
abdollahzadehf@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences.
Full name of responsible person
Farahnaz abdollahzadeh
Position
Master of Sciences
Other areas of specialty/work
Street address
Kosar Dormitory, Shariati Avenue.
City
Tabriz
Postal code
Phone
+98 41 3479 6707
Fax
Email
abdollahzadehf@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences.
Full name of responsible person
Mohammad Gholipour
Position
Bachelor Student
Other areas of specialty/work
Street address
Kosar Dormitory, Shariati Avenue.
City
Tabriz
Postal code
Phone
00
Fax
Email
m.gholipour1374@gmail.com
Web page address

Sharing plan

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