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The effect of Team education on HbA1c levels in patients with diabetes type 2

Protocol summary

Study aim
Determine the effect of teamwork on HbA1c in patients with type 2 diabetes
Design
To determine the sample size, the guide study and the mean comparison formula with 95% confidence interval and 80% test power were used, 35 of which were estimated in each group (23). Considering the probable loss of samples, 40 people were estimated for each group. Therefore, 80 patients with type 2 diabetes in the diabetes unit of Bahar in 1395 would be eligible for a simple random sampling in two intervention and control groups.
Settings and conduct
The present study is an interventional study with the aim of evaluating the effect of teamwork on HbA1c in patients with type 2 diabetes in diabetes mellitus in Bahar in 1396. The population under study in this study is type 2 diabetes patients living in Bahar, Hamadan province, who are referred to the diabetes department. The main tool of the research is a questionnaire containing personal information and patient's laboratory and educational records.
Participants/Inclusion and exclusion criteria
Admission criteria for inclusion in the study include: aged 30 years and above, at least one year after diagnosis of type 2 diabetes, patients treated with oral pill, patients treated with insulin injections, and patients treated with both methods Treatment, having at least literacy, reading and writing, and having.Exclusion criteria include discontinuation of entry into the study, the occurrence of gestational diabetes, complications of diabetes mellitus such as kidney stroke, blindness, etc., of severe illnesses such as various cancers and other chronic and debilitating illnesses. The need for home care is the occurrence of a variety of diseases that affect the level of HbA1c, such as the occurrence of anemia, hemoglobinopathy, uremia, kidney failure, etc., the types of diseases that affect the understanding or receipt of patient support The family is affected, such as having a mental illness or having an addiction.
Intervention groups
The number of training sessions in the intervention group was performed by the diabetes team of the diabetes community in Bahar city, consisting of 3 people (internist, nurse and nutrition expert); 12 sessions of maximum 3 hours (4 sessions each month). The intervention group was randomly divided into four groups: 13-12 They will receive a training session each month (in the whole intervention group they will attend 3 times in the training sessions). In each session, each member of the trainer will provide at least 0.5 hours of relevant training to the intervention team and their attendants, and then answer 0.5 hours to the questions and answers of the patients.
Main outcome variables
Reduce complications of diabetes, increase patient quality of life, self-care in patients, counseling and team training on disease improvement, lifestyle changes in patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171202037702N1
Registration date: 2018-01-09, 1396/10/19
Registration timing: prospective

Last update: 2018-01-09, 1396/10/19
Update count: 0
Registration date
2018-01-09, 1396/10/19
Registrant information
Name
Alireza Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3450 9994
Email address
ali.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Team education on HbA1c levels in patients with diabetes type 2
Public title
The effect of Team education on HbA1c levels in patients with diabetes type 2
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 30 years and older, at least one year after diagnosis of type 2 diabetes, patients treated with oral contraceptives, patients treated with insulin injections, and patients treated with both methods of treatment, having at least reading and writing skills
Exclusion criteria:
Dissatisfaction with entering the study, having diabetes, pregnancy complications, diabetes mellitus such as kidney stroke, blindness, etc., serious illnesses such as various cancers and other chronic and debilitating diseases that require home care Have a variety of diseases that affect HbA1c levels, such as all types of anemia, hemoglobinopathies, uremia, kidney failure, and the like of a variety of diseases that affect the understanding or support of the patient's family support, such as Having a mental illness or having an addiction
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
They were randomly divided into two intervention and control groups(Use the random numbers table)
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 Hamedan University of Medical Sciences
Street address
Shariati Street
City
hamadan
Province
Hamadan
Postal code
65178838678
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.UMSHA.REC.1396.567

Health conditions studied

1

Description of health condition studied
Team education
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Reducing HbA1c
Timepoint
Prior to entering the study, the patient performed the relevant test within the last 2-4 weeks at the selected central lab of the city or will be requested by a specialist physician. As well as the results of the HbA1c test in two intervention and control groups after the study, which the patient will undergo the relevant test 8-12weeks after training in the selected central lab of the city.
Method of measurement
With the Hiccard Marker HbA1C (NYCOCARD)

Secondary outcomes

empty

Intervention groups

1

Description
The number of training sessions in the intervention group was performed by the diabetes team of the diabetes community in Bahar city, consisting of 3 people (internist, nurse and nutrition expert); 12 sessions of maximum 3 hours (4 sessions each month). The intervention group was randomly divided into four groups: 13-12 They will receive a training session each month (in the whole intervention group they will attend 3 times in the training sessions). In each session, each member of the trainer will provide at least 0.5 hours of relevant training to the intervention team and their attendants, and then answer 0.5 hours to the questions and answers of the patients.
Category
Prevention

2

Description
The control group receives routine training and treatment according to the routine diabetes plan. In routine training, the patient is trained by a nurse, doctor or counselor, and only the steps that the patient needs to follow is provided to him at each visit (if he has time) by a member of the diabetes team. In some cases, due to the busy unit of diabetes, a person may not have normal training.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
diabetes unit of bahar
Full name of responsible person
mahdi rezvan
Street address
Imam street
City
bahar
Province
Hamadan
Postal code
651833147
Phone
+98 81 3451 1340
Fax
+98 81 3450 9994
Email
moradi783@yahoo.com
Web page address
http://shb.umsha.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shariati
City
hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0572
Email
bashiri_3@yahoo.com
Web page address
http://research.umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
alireza moradi
Position
Employee
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
emam
City
bahar
Province
Hamadan
Postal code
6513833147
Phone
+98 81 3450 9994
Fax
+98 81 3450 9994
Email
ali.moradi@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Moradi
Position
MSc
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
Shryati
City
Hamedan
Province
Hamadan
Postal code
6531833147
Phone
+98 81 3450 9994
Fax
Email
moradi783@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Moradi
Position
MSc
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
Shryati
City
Hamedan
Province
Hamadan
Postal code
6531833147
Phone
+98 81 3450 9994
Fax
Email
moradi783@yahoo.com

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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