A comparison of the effectiveness of empowerment program of nurses and health services providers in self-care of middle-aged people with diabetes of selected comprehensive health centers of Isfahan in 2018.
The effectiveness of empowerment program of nurses and health services providers in self-care of middle-aged people with diabetes of selected comprehensive health centers
Design
This study is a non-blinded clinical trial. The study population will be included nurses and health care providers at Isfahan Health Center No. 1. A total of 480 eligible people will be selected conveniently and randomly will be assigned to four groups (two intervention groups and two control groups)
Settings and conduct
This study which will be conducted in Isfahan Health Center No. 1,is non-blinded one.At the beginning of the study and the end of the study, self-care questionnaire will be provided for middle-aged people
Participants/Inclusion and exclusion criteria
Inclusion criteria: Service providers (nurses and health care providers) working in comprehensive health centers; Middle-aged people aged between30- 59 years old
Exclusion criteria: Not having a bachelor's degree in nursing and carers be the bachelor of disease control, public health or family health; Illiterate
Intervention groups
In the first intervention group, nurses will be trained self-care in empowerment program of nurses and health services providers of Comprehensive Health Services Centers for seven sessions.
In the second intervention group, health care providers will be involved in self-care education of Comprehensive Health Services Centers for seven sessions.
In the first control group, nurses will not receive any training.
In the second intervention group, health care providers will not receive any training
Main outcome variables
Self-care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181225042121N1
Registration date:2019-01-07, 1397/10/17
Registration timing:registered_while_recruiting
Last update:2019-01-07, 1397/10/17
Update count:0
Registration date
2019-01-07, 1397/10/17
Registrant information
Name
masoume karimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3500 2118
Email address
masoume.karimian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effectiveness of empowerment program of nurses and health services providers in self-care of middle-aged people with diabetes of selected comprehensive health centers of Isfahan in 2018.
Public title
A comparison of the effectiveness of empowerment program of nurses and health services providers in self-care of middle-aged people with diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Receive notification from the health department of Isfahan province.
Service providers (nurses and health care providers) working in comprehensive health centers.
Diagnosis of type 2 diabetes by the doctor ( FBS≥ 126 or taking diabetes medication.
Middle aged people aged between30- 59 years old
Exclusion criteria:
Not having a bachelor's degree in nursing and carers be the bachelor of disease control, public health or family health.
Illiterate
Age
From 30 years old to 59 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
480
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
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
Committee Ethics, Islamic Azad University Esfahan Branch
Street address
University Blvd. Arghavaniyeh,East G Street,
City
Esfahan
Province
Isfehan
Postal code
۳۹۹۹۸۸۱۵۵۱
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.157
Health conditions studied
1
Description of health condition studied
Type II diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
self-care
Timepoint
The beginning and end of the study
Method of measurement
Based on the self-care questionnaire of Tubert
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, nurses will be trained self-care in empowerment program of nurses and health services providers of Comprehensive Health Services Centers for seven sessions
Category
Lifestyle
2
Description
In the second intervention group, health care providers will be involved in self-care education of Comprehensive Health Services Centers for seven sessions
Category
Lifestyle
3
Description
In the first control group, nurses will not receive any training.
Category
Other
4
Description
In the second intervention group, health care providers will not receive any training
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 1 in Isfahan
Full name of responsible person
Masomeh Karimian
Street address
Roknulmolk crossroad,Feyz Street,
City
Esfahan
Province
Isfehan
Postal code
3999881548
Phone
+98 31 3662 0880
Email
masoume.karimian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Majid Toghyani
Street address
University Blvd, Arghavaniyeh, East G Street
City
Esfahan
Province
Isfehan
Postal code
۳۹۹۹۸۸۱۵۵۱
Phone
+98 31 3535 4033
Email
Research@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Masomeh Karimian
Position
MSc student of Nursing and Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University Blvd, Arghavaniyeh, East G Street
City
Kermanshah
Province
Isfehan
Postal code
۳۹۹۹۸۸۱۵۵۱
Phone
+98 31 3535 4033
Email
masoume.karimian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mino Motaghi
Position
Faculty Member of Isfahan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University Blvd, Arghavaniyeh, East G Street
City
Esfahan
Province
Isfehan
Postal code
۳۹۹۹۸۸۱۵۵۱
Phone
+98 31 3535 4001
Email
m.motaghi@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masomeh Karimian
Position
MSc student of Nursing and Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University Blvd, Arghavaniyeh, East G Street
City
Esfahan
Province
Isfehan
Postal code
۳۹۹۹۸۸۱۵۵۱
Phone
+98 31 3535 4033
Email
masoume.karimian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
5 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail