Determining the effect of self-care training on the quality of life of elderly women with type 2 diabetes covered by health care centers of Shahid Beheshti University of Medical Sciences.
Design
Two stages before and after in two intervention and control groups, sampling by cluster method, sample size: 52 people in each group (total: 104 people), selection of 3 clusters and random selection from each center, 2 comprehensive health service centers
Settings and conduct
Explaining the objectives and duration of the study to the participants
Self-care training in 7 sessions for 30 to 60 minutes for 2 months
Educational materials include: general self-care, exercise and nutrition, mental health, foot care
Location: comprehensive health service centers
Participants/Inclusion and exclusion criteria
Entry requirements: female gender, suffering from type 2 diabetes, having basic literacy, having a health record in the Sib system
Exit conditions: immigration, death, hospitalization
Intervention groups
Providing diabetes self-care education to the intervention group
Failure to provide diabetes self-care education to the control group
Main outcome variables
Quality of life of elderly women with type 2 diabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230305057625N1
Registration date:2023-05-20, 1402/02/30
Registration timing:retrospective
Last update:2023-05-20, 1402/02/30
Update count:0
Registration date
2023-05-20, 1402/02/30
Registrant information
Name
Fatemeh sadat Nekoee Avanjee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 9140
Email address
nekoee1376@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-31, 1401/11/11
Expected recruitment end date
2023-05-01, 1402/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education on the quality of life of old women with type2 diabetes
Public title
The effect of self-care education on the quality of life of old women with type2
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The gender of the person is female.
A person with type 2 diabetes.
The person's age should be 60 years or older.
The person has basic literacy.
The person has a health record in the Sib system.
A person does not suffer from severe diseases and disabilities such as blindness, amputation, heart, respiratory, brain, and kidney problems which need to be dialyzed.
The person wants to participate in the study.
Exclusion criteria:
The person is blind.
A person with heart disease.
The person has a respiratory disease.
The person has a brain disease.
A person with kidney disease leading to dialysis.
The person has an amputation.
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Not 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
Ethics Committee of Faculty of Health and Neurosciences Shahid Beheshti University of Medical Scienc
before the intervention and one month after the intervention
Method of measurement
Lipad quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1, providing self-care education in the field of diabetes in 7 sessions, each session for 30 to 45 minutes, including topics, general and special care, importance and prevalence of diabetes in the elderly, symptoms and complications of diabetes, exercise and nutrition, foot care, consumption Medicine, mental health
Category
Lifestyle
2
Description
The first control group: not providing self-care training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dokmeh chee comprehensive health service center
Full name of responsible person
Fatemeh sadat Nekoee
Street address
Kerman St
City
Tehran
Province
Tehran
Postal code
1634754691
Phone
+98 21 2252 5140
Email
nekoee1376@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Taleghani comprehensive health service center
Full name of responsible person
Fatemeh Sadat Nekoee
Street address
Dezashib St
City
Tehran
Province
Tehran
Postal code
1935617351
Phone
+98 21 2275 8689
Email
nekoee1376@sbmu.ac.ir
3
Recruitment center
Name of recruitment center
Salavati Comprehensive Health Service Center
Full name of responsible person
Fatemeh sadat Nekoee
Street address
Piroozi street
City
Tehran
Province
Tehran
Postal code
000000000
Phone
+98 21 7742 8070
Email
nekoee1376@sbmu.ac.ir
4
Recruitment center
Name of recruitment center
Chizar comprehensive health service center
Full name of responsible person
Fatemeh sadat Nekoee
Street address
Chizar
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2221 9085
Email
nekoee1376@sbmu.ac.ir
5
Recruitment center
Name of recruitment center
Ahmadi comprehensive health service center
Full name of responsible person
Fatemeh Sadat Nekoee
Street address
Damavand St
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 7758 3367
Email
nekoee1376@sbmu.ac.ir
6
Recruitment center
Name of recruitment center
Jafari Comprehensive Health Service Center
Full name of responsible person
Fatemeh Sadat Nekoee
Street address
17 Shahrivar St
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 3313 1812
Email
nekoee1376@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Student Blvd , Shahid Beheshti University of Medical Sciences, Faculty of Health and Safety
City
Tehran
Province
Tehran
Postal code
1983535511
Phone
+98 21 2243 1993
Email
mkarami@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data that can be published from this study include the following: patient age, education, employment status, life status, level of quality of life before and after the intervention, level of anxiety and depression before and after the intervention, level of changes in self-care scores before and after From the intervention, the amount of changes in life satisfaction scores before and after the intervention, the amount of changes in life status scores before and after the intervention
When the data will become available and for how long
The access period will start 6 months after the project results are published in the form of an article.
To whom data/document is available
The data obtained from this study will be available to researchers who intend to design a similar study.
Under which criteria data/document could be used
It is possible to use the data to evaluate the effectiveness of self-care training and conduct analyzes that compare the average of the variables.
From where data/document is obtainable
Researchers can contact the person in charge of data collection through the following email to get the data:nekoee1376@sbmu.ac.ir
What processes are involved for a request to access data/document
The applicant must first submit the proposal and the code of ethics of the project that he intends to implement to the person in charge of collecting the project, and after the review by the project executive team, the information will be provided to him within a period of one month.