1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
The effect of family-centered empowerment model on the burden of care and self-efficacy of parents with a child with Type 1 diabetes
Protocol summary
Study aim
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
+98 915 698 1406 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
2 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
3 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
4 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
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
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
Comments
