Determining the effect of family-centered and individual-centered education on self-efficacy of patients with type 2 diabetes
Determining and comparing the mean score of self-efficacy in patients in the intervention and control groups before and after education
Determining and comparing the mean score of self-esteem in patients in the intervention and control groups before and after education
Determining and comparing the mean scores of FBS, 2HPP, TG, CHOL, HbA1C tests in patients in the intervention and control groups before and after education
Design
This clinical trial will be performed in parallel groups on 80 patients with type 2 diabetes.
Settings and conduct
This project is carried out in Yazd Diabetes Research Center. From the patients referred to the center, 80 patients are randomly selected and divided into two groups. One group receives training with a family member and the other group receives training alone.
Participants/Inclusion and exclusion criteria
History of diabetes for at least one year;
Having a medical record at the Diabetes Center;
Drug treatment with insulin;
Lack of impaired hearing and vision problems and mental illness;
Literacy for reading and writing;
The patient's relatives are not medical or care staff;
Intervention groups
Patients in the intervention group are accompanied by a family member who has a caring role, will be participated in 7 sessions of 40 to 45 minutes and, the second group of patients will receive individual training.
Main outcome variables
Self-efficacy; self-esteem
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200426047208N2
Registration date:2021-05-16, 1400/02/26
Registration timing:retrospective
Last update:2021-05-16, 1400/02/26
Update count:0
Registration date
2021-05-16, 1400/02/26
Registrant information
Name
Akram Mehrabbeik
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3728 0226
Email address
mehrabbeyk@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of family-centered and patient-centered education on self-efficacy and self-esteem of patients with type 2 diabetes.
Public title
The effect of education on self-efficacy and self-esteem of patients with diabetes.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
History of diabetes for at least one year
Having a medical record at the Diabetes Center
Drug treatment with insulin
Lack of impaired hearing and vision problems and mental illness
Literacy for reading and writing
The patient's relatives are not medical or care staff
Exclusion criteria:
History of depression and mental illness
History of death of first-degree relatives during the last 6 months
History of participating in training classes
Age
From 18 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
Simple random sampling is used. First, it is assigned to the file of each eligible patient and then using the software random allocation And specifying the sample size and number of groups by generating a random sequence, the samples of each group (family-centered and patient-centered) are determined.
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 shahid sadoughi university of medical sciences
Street address
Bahonar squire
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.SSU.RSI.REC.1398.048
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Self-efficacy score
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Diabestes Management Self –Efficacy questionnaire
2
Description
Self esteem score
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Coopersmith Self-Esteem Inventory
3
Description
FBS
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
blood test
4
Description
HA1c
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
blood test
5
Description
Cholesterol
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
blood test
6
Description
2hpp
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: patients with an active family member will be educated in In 7 sessions of 40 to 45 minutes for 7 weeks(one session per week).Training based on the family-centered empowerment model (empowering the patient and active family member to promote the patient's health) will be provided one week after the introductory session, thus the family-centered empowerment model in four steps of perceived limitation, problem solving, strengthening Self-esteem and evaluation will be done.
Category
Behavior
2
Description
Intervention group2: patients will be educated in In 7 sessions of 40 to 45 minutes for 7 weeks(one session per week).Training based on the patient-centered empowerment model (empowering the patient to promote their health) will be provided one week after the introductory session, thus the patient-centered empowerment model in four steps of perceived limitation, problem solving, strengthening Self-esteem and evaluation will be done.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center
Full name of responsible person
Bahare Fallah
Street address
No. 32. Shahid Beheshti Alley. South Salman Street.Yazd.
City
Yazd
Province
Yazd
Postal code
891574534396
Phone
+98 35 3824 1751
Email
baharefallah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
The central building of Yazd University of Medical Sciences, Bahonar Square, Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3146 2136
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Bahare Fallah
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 32. Shahid Beheshti Alley. South Salman Street.Yazd.
City
یزد
Province
Yazd
Postal code
891574534396
Phone
+98 35 3824 1751
Email
baharefallah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Bahare fallah
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 32. Shahid Beheshti Alley. South Salman Street.Yazd.
City
Yazd
Province
Yazd
Postal code
891574534396
Phone
+98 35 3824 1751
Email
baharefallah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Bahare fallah
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 32. Shahid Beheshti Alley. South Salman Street.Yazd.
City
Yazd
Province
Yazd
Postal code
891574534396
Phone
+98 35 3824 1751
Email
baharefallah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All researchers
Under which criteria data/document could be used
Carrying out research activities by mentioning the source
From where data/document is obtainable
Bahare fallah
baharefallah@gmail.com
What processes are involved for a request to access data/document
The files will be sent to them one week after receiving the requesting email.