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The effect of Home visit programe on self- management behaiviors and glycemic control in Patients with Type 2 Diabetes treated by Insulin referred to shahid Asghar shabani diabetes clinic in Isfahan 2018-19.

Protocol summary

Study aim
Determination of the effect of home visit program on self-management behaviors and blood glucose control indices in patients with type 2 diabetes mellitus treated with diabetes mellitus in Shahid Asghar Shaban Esfahan, 2018-19
Design
This is a randomized controlled clinical trial that was conducted in a three-stage and two-group method by selecting 64 samples of patients with type 2 diabetes in Isfahan. Before performing the intervention, the researcher sampled in an accessible month. In order to randomly assign samples to the two groups, the researcher wrote the sample names on small sheets after the end of the sampling, and started inserting the sheets out of the box without inserting them. In this way, the person (first, third, and ...) was assigned to the control group to the intervention group and the couple (second, fourth, and ...).
Settings and conduct
In this research, firstly, need assessment and sampling in the unit of education were carried out to the patient of the specialized clinic of Shahid Asghar Shabani Esfahan Diabetes Mellitus, and then home visit visits were held at the patients' homes.
Participants/Inclusion and exclusion criteria
1-There is a definite diagnosis of type 2 diabetes by a specialist 2. Being treated with insulin (pen or syringe). 3. Have a file in the center 4.Passed at least one year of diagnosis 5. The patient is 40 to 60 years old. 6.Lack of HbA1C control according to the doctor's opinion 7. The fasting blood glucose is greater than or equal to 126. Exit criteria: 1. A relative or neighbor is another participant in the study. 2. Getting complications of illness or any other reason (immigration, death, etc.)
Intervention groups
Teaching self-management behaviors by doing a home visit schedule and Receive education by the control group
Main outcome variables
Self-management behaviors, blood glucose control (fasting glucose and glycosylated hemoglobin)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130801014242N3
Registration date: 2019-10-06, 1398/07/14
Registration timing: retrospective

Last update: 2019-10-06, 1398/07/14
Update count: 0
Registration date
2019-10-06, 1398/07/14
Registrant information
Name
Maryam Shirazi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2904
Email address
m_shirazi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-07-14, 1397/04/23
Actual recruitment start date
2018-06-10, 1397/03/20
Actual recruitment end date
2018-07-14, 1397/04/23
Trial completion date
2018-09-06, 1397/06/15
Scientific title
The effect of Home visit programe on self- management behaiviors and glycemic control in Patients with Type 2 Diabetes treated by Insulin referred to shahid Asghar shabani diabetes clinic in Isfahan 2018-19.
Public title
The effect of Home visit programe on self- management behaiviors and glycemic control
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1- There is a definite diagnosis of type 2 diabetes by a specialist Being treated with insulin (pen or syringe). Have a file in the center. At least one year has passed since they diagnosed their illness. Have the desire to participate in research and get home visits. No cognitive impairment. Ability to speak and understand fully the Persian language and have a reading and writing literacy The patient is 40 to 60 years old. Is located in Isfahan. HbA1C is considered to be uncontrolled according to the medical records of the patient and the doctor's opinion. The fasting blood glucose is greater than or equal to 126. Due to the distance to the center, it is not possible to get regular visits to the center (at least 1-2 times a month) to receive education. Be a lady The long-term complications of diabetes have not been diagnosed. Previously, they have not participated in home visits for diabetes.
Exclusion criteria:
A relative or neighbor is another participant in the study. The patient's unwillingness to continue participating in the study If you have any complications of illness or any other reason (migration, death, etc.), the patient should be excluded from the investigator's access to the hospital for admission to hospital.
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Actual sample size reached: 64
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign samples to the intervention and control groups, the researcher will write the names of the samples on small sheets after the completion of the sampling and place them in the box and begin to remove the sheets without inserting them from the box. Individuals (first, third, ...) will be assigned to the control group to the intervention group and the couple (second, fourth, and ...).
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 Isfahan University Of Medical Sciences
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
13133437
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.MUI.REC.1396.3.871

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Self Management Behavior
Timepoint
Before, After and 3 month After The Prevention
Method of measurement
DSMQ Self Management Questionnaire

2

Description
Glycemic Control
Timepoint
Before and 3 month After The Prevention
Method of measurement
Blood Sampling (FBS and HbA1C)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Performing a home visit program (3-5 sessions) for each client and training self-management behaviors during home visits and taking fasting blood sugar and HbA1c samples at baseline and three months after interventions.
Category
Behavior

2

Description
Control group: Sampling of fasting blood sugar and HbA1c at baseline and three months after sampling and then giving them educational booklets.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
shahid Asghar shabani diabetes clinic in Isfahan
Full name of responsible person
Maryam Shirazi
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
13133437
Phone
+98 31 3792 7585
Email
m_shirazi@nm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Norouzi
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
13133437
Phone
+98 31 3792 7585
Email
norouzi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Shirazi
Position
Academic Member, Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
13133437
Phone
+98 31 3792 7585
Email
m_shirazi@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Shirazi
Position
Academic Member, Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
13133437
Phone
+98 31 3792 7585
Email
m_shirazi@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Shirazi
Position
Academic Member, Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezarjirib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
13133437
Phone
+98 31 3792 7585
Email
m_shirazi@nm.mui.ac.ir

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