Determining the effect of family-centered empowerment model on the care burden and self-efficacy of parents with a child with type 1 diabetes
Design
Simple randomized, 100 patients, randomized controlled field trial
Settings and conduct
Prepares a list of health centers in Birjand, then by referring to the main health centers (Javadieh, Rajai, Tohid, Ghadir and Avini centers) based on the number of patients in each center, first based on inclusion criteria, people are selected and then based on sampling A simple random number based on even or odd numbers is assigned to two groups of test and control.
Participants/Inclusion and exclusion criteria
Parents of children 6 to 14 years old. Parents with a child with approved diabetes 3. Having a health record in health centers 4. At least 6 months after the diagnosis of the child 5. Having a minimum literacy and exclusion criteria include 1. Reluctance to participate in research 2. Absence Completion of all questionnaire questions 3. Failure to send the questionnaire by the participant at the specified time 4. Absence of more than one session in training sessions
Intervention groups
The designed educational program will be done in 5 sessions of 90 minutes for 5 weeks, in group sessions with the active participation of parents in the form of discussions, questions and answers by the researcher in health centers using teaching aids such as whiteboards, PowerPoint and educational pamphlets. And the control group will not receive any training
Main outcome variables
The burden of care is the score that a person obtains from the standard 22-item questionnaire designed by Zarit et al., Whose score range is 0-88; self-efficacy is the score that a person obtains from the standard 17-item questionnaire designed by Moghimi Fam (1379). It is 17-85, earns
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220130053887N1
Registration date:2022-02-06, 1400/11/17
Registration timing:registered_while_recruiting
Last update:2022-02-06, 1400/11/17
Update count:0
Registration date
2022-02-06, 1400/11/17
Registrant information
Name
Zahra Akhondi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 6832
Email address
zahra.akhondi89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-03, 1400/11/14
Expected recruitment end date
2022-04-18, 1401/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model on the burden of care and self-efficacy of parents with a child with Type 1 diabetes
Public title
The effect of family-centered empowerment model on the burden of care and self-efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Parents of children 6 to 14 years old
Parents of a child with approved diabetes
Having a health record in health centers
At least 6 months after the diagnosis of the child's disease
Have a minimum literacy
Exclusion criteria:
Reluctance to participate in research
Failure to complete all questionnaire questions
Failure to send the questionnaire by the participant in due time
Absence of more than one session in training sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Birjand city has five health centers (Javadieh, Rajai, Tohid, Ghadir and Avini centers) that the electronic file of all people referring to these centers is registered in the apple system, so the researcher to sample each of these centers Refer and remove the list of all children with type 1 diabetes from the system, and then based on the inclusion criteria and the willingness of the patient's parents to participate in the study, participants are selected in each center and according to the sample size, from the centers Sampling will be done. The final selected samples of the centers are then randomly assigned to one of the intervention or control groups in such a way that first the list of all people from 1 to 100 will be numbered (according to the sample size) and then on 50 The letter A will be written (for the intervention group) and on 50 sheets of the letter B (for the control group) and all these sheets will be mixed in one container and then the sheets will be randomly selected one by one without placing them outside the container. And their sequence is recorded. According to the sequence created and the numbered list, these letters are assigned to the numbers in order, so the groups of each participant (intervention or control) will be determined. This will be done by someone outside the study.
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 birjand University of Medical Sciences
Street address
Ghaffari St., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2022-01-18, 1400/10/28
Ethics committee reference number
IR.BUMS.REC.1400.343
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Care load is the score that a person obtains from the standard 22-item questionnaire designed by Zarit et al., Whose score range is 0-88.
Timepoint
Before the intervention, after the training, 3 months after the end of the last training session
Method of measurement
Questionnaire for assessing the burden of care of Zarit et al
2
Description
Self-efficacy In this study, Scharrer self-efficacy refers to the score that a person obtains from a standard 17-item questionnaire designed by Moghimi Pham (2000) whose score range is 17-85.
Timepoint
Before the intervention, after the training, 3 months after the end of the last training session
Method of measurement
Scherer Self-Efficacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention training includes: The first step in the threat-based empowerment model is to understand that training materials related to illness, symptoms, complications, self-care methods (nutrition, physical activity, medication, etc.) will be discussed in a 90-minute session. At the end of each session, an educational pamphlet will be provided to parents to explain the learning material to the child in their own language. The second step will be problem solving, which will be held during a session using group problem-solving methods. Explain the goals, categorize and prioritize the goals, provide solutions and select the best solution and discuss the best solution. The third step is the skills needed to better control diabetes, including testing blood sugar using Glucometer, how to store insulin and how to draw and inject correctly using an insulin syringe in theory and practice. The fourth step will be educational participation. This step will ask parents to teach what they have learned and learned skills to another family member. . Step 5 Evaluate the process during the intervention in the previous sessions by asking and answering questions about what was said in the previous sessions
Category
Other
2
Description
Control group: At the end of the intervention, all educational booklets and pamphlets will be provided to the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand Health Centers
Full name of responsible person
Asma Nikkhah Bidokhti
Street address
Ghaffari St., Birjand University of Medical Sciences
City
Qaen
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
asmanikkhah52@gmail.com
Web page address
https://www.bums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammd Reza Miri
Street address
Ghaffari St., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
public_r@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zahra Akhondi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Ghaffari St., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 915 698 1406
Fax
Email
zahra.akhondi89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Asma Nikkhah Bidokhti
Position
coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
17 Shahrivar Square, Qaen School of Nursing and Midwifery
City
Qaen
Province
South Khorasan
Postal code
9761988978
Phone
+98 56 3253 1733
Email
asmanikkhah52@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zahra Akhondi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Ghaffari St., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 915 698 1406
Fax
Email
zahra.akhondi89@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All relevant information will be published
When the data will become available and for how long
Start access 6 months after printing results
To whom data/document is available
Researchers of Birjand University of Medical Sciences
Under which criteria data/document could be used
The reason for the need for information
From where data/document is obtainable
Email the responsible author
What processes are involved for a request to access data/document
Email the author and introduce yourself and the reason for the need