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The effect of family-centered empowerment model on the burden of care and self-efficacy of parents with a child with Type 1 diabetes

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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)

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)

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)

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

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

Comments

Referensi

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Blinding investigator's opinion Not blinded Blinding description Placebo Not used Assignment Parallel Other design features Secondary Ids empty Ethics committees 1 Ethics

Blinding investigator's opinion Not blinded Blinding description Placebo Not used Assignment Parallel Other design features Secondary Ids empty Ethics committees 1 Ethics