Determining the Effect of Family-Based Empowerment Model on Quality of Life and Self-efficacy in Children with Rheumatoid Arthritis.
Design
Clinical trial with control and intermediate group, randomized with sample size 60 (30 controls and 30 intervention groups)
Settings and conduct
This study was a randomized controlled clinical trial. Sixty children with rheumatoid arthritis were randomly divided into two groups, randomly and in the rheumatology department of Akbar Children Hospital in Mashhad. Four phases of family-centered empowerment model (knowledge upgrading, self-efficacy, self-esteem and evaluation) through Face-to-face education, practical demonstration, educational participation and presentation of a training book were conducted for six 45-minute sessions for the experimental group. After one month, the questionnaire Quality of life and self-efficacy were completed by children.
Participants/Inclusion and exclusion criteria
The criteria for entering the study: the children and their parents tend to participate in the study; ages 8 to 12 years old; diagnosis of rheumatoid arthritis according to the physician (at least 3 months ago); lack of specific mental illness; the child's ability to complete the questionnaire and participate in the study. The empowerment plan has no other chronic disease other than rheumatoid arthritis.
Incapacity: the child and parents' desire to leave the study; creating a special incident affecting the quality of life and the underlying illness and mental disorder.
Intervention groups
Children with rheumatoid arthritis
Main outcome variables
Family-centric empowerment model
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180319039131N1
Registration date:2019-03-27, 1398/01/07
Registration timing:retrospective
Last update:2019-03-27, 1398/01/07
Update count:0
Registration date
2019-03-27, 1398/01/07
Registrant information
Name
Nahid Pilehvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3766 5593
Email address
pilehvarn941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-04-03, 1398/01/14
Scientific title
Effect of Family-Centered Empowerment Model on Quality of Life and Self-Efficacy in Children with Rheumatoid Arthritis.
Public title
Effect of Family-Centered Empowerment Model on Quality of Life and Self-Efficacy in Children with Rheumatoid Arthritis.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The tendency of the child and their parents to participate in the study
Aged 8 to 12 years old
Diagnosis of rheumatoid arthritis according to the physician (at least 3 months ago)
Lack of specific mental illness
The child's ability to complete the questionnaire
Absence of other chronic disease other than arthritis rheumatoid
Exclusion criteria:
The desire of the child and parents to leave the study
Creating a special incident that affects the quality of life and the development of a known mental and psychological disorder
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The assignment of research units to random and control groups was intervention and control. In order to prevent data leakage in the two groups after the draw, the sampling from the control group first began. After sampling in this group, the intervention group sampling was started
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Khorasan Razavi, Mashhad, Blvrshahid Fakori, Shahid Javan Square and Shahidi Square, Science and Welfare
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Approval date
2018-02-09, 1396/11/20
Ethics committee reference number
IR.MUMS.REC.1396.391
Health conditions studied
1
Description of health condition studied
Juvenile Rheumatoid Arthritis
ICD-10 code
M08.0
ICD-10 code description
Juvenile rheumatoid arthritis
Primary outcomes
1
Description
Quality of Life
Timepoint
Measurement of quality of life in the beginning of the study (before the beginning of the study) and one month after the implementation of the family-centered empowerment model
Method of measurement
PedsQL Questionnaire; Quality of life for children ages 8 to12
2
Description
Self-efficacy
Timepoint
Measurement of self-efficacy in the beginning of the study (before the beginning of the study) and one month after the implementation of the family-centered empowerment model
Method of measurement
Self-efficacy questionnaire SEQ-C
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the implementation of the family-centered empowerment model consists of four steps (knowledge upgrading, self-efficacy, self-esteem and evaluation) on children with rheumatoid arthritis
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Rheumatology, Akbar Hospital
Full name of responsible person
Abdolreza Malek (Head of Department of Rheumatology)
Street address
No. 14 , Shahid Kaveh Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9196697435
Phone
+98 51 3871 3802
Fax
+98 51 3870 9201
Email
pilehvarn941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Zare (Deputy of Finance), Faculty of Nursing
Street address
Ebne Sina Street,Faculty of Nursing and Midwifery, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3859 1511
Email
zareMD@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
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
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Pilehvar
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.95, West Hedayat Blvd., Hedayat 35/10
City
Mashhad
Province
Razavi Khorasan
Postal code
9196696665
Phone
+98 51 3751 7971
Email
pilehvarn941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Pilehvar
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 95 , West Hedayat Blvd., Hedayat 35/10
City
Mashhad
Province
Razavi Khorasan
Postal code
9196696665
Phone
+98 51 3751 7971
Email
pilehvarn941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Pilehvar
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.95, West Hedayat Blvd., Hedayat 35/10
City
Mashhad
Province
Razavi Khorasan
Postal code
9196696665
Phone
+98 51 3751 7971
Email
pilehvarn941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available