Effect of an empowerment program on health _ related quality of life of type 1diabetic adolescents.
Design
This is a clinical trial study of N=54 adolescent with T1DM from karbala Iraq
Settings and conduct
This research will be done in 2 stage. Firstly, the adolescent empowerment package is collected based on the necessities mentioned in print and online sources. In the second stage, after obtaining permission from the ethics committee of the Mashhad University of Medical Sciences, sampling will be done in Imam Hussein (PUH) Hospital in Karbala via convenience method. Also assignment will be done randomly via simple random method. Demographic. Michigan Diabetes Knowledge Test and KIDSCREEN questionaire will be used for data collection. Then the empowerment program for the intervention group will be implemented in groups of 6 to 8 people, and in 10 session, tree session per week.
The control group will receive routine care. After 10 weeks of intervention and 4 weeks after completing intervention, the quality of life score will be measured and compared again in the tow group. Data analysis will be done using SPSS 16. To observe ethical points after completing intervention and data collection, this package will be implemented for volunerees of the control group.
Participants/Inclusion and exclusion criteria
Satisfaction with participation in the study
Child age between 12_18 years
Have a minimum literacy of parents and children.
Do not suffer from complications of diabetes.
Being a resident of Karbala.
Intervention groups
Intervention group: 12-18 years old teenagers that will receive empowerment program.
Control group: 12-18 years old teenagers that will receive routine care
Main outcome variables
health _ related quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220119053762N1
Registration date:2022-02-10, 1400/11/21
Registration timing:prospective
Last update:2022-02-10, 1400/11/21
Update count:0
Registration date
2022-02-10, 1400/11/21
Registrant information
Name
Aramesh Rezaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
rezaeiana@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-22, 1400/12/03
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of empowerment program on quality of life in adolescents with type 1 diabetes
Public title
Effect of empowerment on health _ related quality of life in type 1diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction with participation in the study
Age between 12 and 18 years
Minimum literacy in the child
No complications of diabetes
Stay in Karbala
Exclusion criteria:
Age
From 12 years old to 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization in such a way that people with type 1 diabetes who are eligible to enter the study are selected and placed in the control and intervention group with a simple lottery.
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 Mashhad School of Nursing and Midwifery
Street address
Taghiabad Square, School of Nursing and Midwifery, Mashhad
City
Mashad
Province
Razavi Khorasan
Postal code
۹۱۷۷۸۱۶۵۵۹
Approval date
2022-01-03, 1400/10/13
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.075
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
Health Related Quality of Life
Timepoint
Before the intervention and 4 weeks after the end of the intervention
Method of measurement
Kidscreen tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: 12-18 years old teenagers that will receive empowerment program.Then the empowerment program for the intervention group will be implemented in groups of 10 to 15 people, and in 10 session, tree session per week. ،he adolescent empowerment package is collected based on the necessities mentioned in print and online sources. These dimensions are: 1- Theoretical nature of the disease, 2- Limited knowledge of acute complications, 3- How to prevent and deal with each of the acute complications, 4- Self-care in the field of insulin injection,5- Activity self-care, 6- Nutritional self-care7- Limited knowledge of long-term complications and prevention of long-term complications.
Category
Lifestyle
2
Description
Control group: Receive routine diabetes care
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital in Karbala, Iraq
Full name of responsible person
Aramesh Rezaian
Street address
No. 6, Delavaran Boulevard, mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177816559
Phone
+98 51 3859 1511
Email
rezaeiana@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayyur Mobarhan
Street address
University Street, next to Hoveyzeh Cinema, Ghorashi Building, Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@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
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
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaeian
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.6 , Delavaran Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177816559
Phone
009838591512
Email
rezaeiana@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaeian
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 6, Delavaran Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177816559
Phone
+98 51 3859 1512
Email
Rezaeiana@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaeian
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Delavaran Boulevard, Delavaran 6
City
Mashhad
Province
Razavi Khorasan
Postal code
9177816559
Phone
+98 51 3859 1513
Email
Rezaeiana@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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available