Determining the impact of the treatment adherence promotion program on academic performance and quality of life of adolescents with cystic fibrosis
Design
The quasi-experimental study has one group, sampling in a targeted manner (available), sample size: 48 patients
The results before and after the intervention will be compared on a group of 48 patients.
Settings and conduct
Research environment: respiratory diseases clinic of children's medical center in Tehran
The results before and after the intervention will be compared on a group of 48 patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering from cystic fibrosis, not suffering from learning and cognitive diseases (according to the patient's file), adolescents aged 12-16 years old, being engaged in education, declaration of the consent of the adolescent and parental consent to participate in the study, not suffering from other disorders disabling
Exclusion criteria: In case of dissatisfaction at any stage of the research, failure to participate in 3 or more orientation classes
Intervention groups
The intervention in this research is in the form of a handbook, pamphlet and holding group orientation classes, based on the CF.R.I.S.E. program, the interventions that have been done in other studies to promote treatment compliance and the recommendations of the Cystic Fibrosis Association of Iran, during 6 sessions 60 minutes, it will be done once a week.
Main outcome variables
Adherence to treatment, quality of life, academic performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240718062462N1
Registration date:2024-08-11, 1403/05/21
Registration timing:prospective
Last update:2024-08-11, 1403/05/21
Update count:0
Registration date
2024-08-11, 1403/05/21
Registrant information
Name
soraya hossein pour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 5999
Email address
hosseinpoorsoraya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-10-30, 1403/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of the treatment adherence promotion program on academic performance and quality of life of adolescents with cystic fibrosis
Public title
the impact of the treatment adherence promotion program on academic performance and quality of life of adolescents with cystic fibrosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from cystic fibrosis
Not suffering from learning and cognitive diseases
Adolescents aged 12-16 years
Be busy studying
Declare the adolescent's consent and parents' consent to participate in the study
Not suffering from other debilitating disorders
Exclusion criteria:
In case of lack of satisfaction at any stage of the research, the participants can be excluded from the study
n case of not participating in 3 or more sessions in the orientation classes, the participant will be excluded from the study
Age
From 12 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
N/A
Randomization description
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
Ethics Committee in Research Faculty of Nursing and Midwifery and Faculty of Rehabilitation - Tehran
Street address
No. 62, School of Nursing and Midwifery Tehran University of Medical Sciences, Mirkhani St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2024-07-16, 1403/04/26
Ethics committee reference number
IR.TUMS.FNM.REC.1403.055
Health conditions studied
1
Description of health condition studied
Cystic fibrosis disease
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis
Primary outcomes
1
Description
The quality of life score in the PEDSQL children's quality of life questionnaire
Timepoint
Measuring the quality of life score at the beginning of the study and 30 days after the completion of the training classes
Method of measurement
In this study, the quality of life score of adolescents is measured with the valid and reliable "PEDQL children's quality of life" questionnaire.
2
Description
Academic performance score in the Academic Performance Questionnaire (EPT)
Timepoint
Measuring the academic performance score at the beginning of the study and 30 days after the completion of the experimental classes
Method of measurement
In this study, the academic performance score of adolescents is measured with a valid and reliable "Educational Performance (EPT)" questionnaire.
Secondary outcomes
1
Description
Adolescent treatment adherence score
Timepoint
The treatment compliance score of adolescents is measured at the beginning of the study and 30 days after the completion of the training classes.
Method of measurement
The treatment compliance score in this study is measured with the treatment compliance questionnaire of Modanlo et al.
Intervention groups
1
Description
Intervention group: The current study is quasi-experimental and has a group of 48 teenagers with cystic fibrosis who meet the inclusion criteria. The content of the training will be approved by 10 professors and specialists who are experts in the field of pediatric nursing, as well as by the families and patients themselves, and during 6 training sessions in 6 weeks in the form of 60 minutes using the teaching methods of lectures, questions And the answer, the use of images and educational clips will be held. The intervention in this research will be conducted in the form of handbooks, pamphlets and holding group orientation classes, based on the program of CF.R.I.S.E., interventions that have been carried out in other studies to promote treatment compliance, and the recommendations of the Cystic Fibrosis Association of Iran. Head of the session: Session 1: Lung health and nutrition in CF patients, Session 2: Diabetes and liver diseases in CF patients, Session 3: Infection and its prevention in CF patients, Session 4 : Sexual health of women and men with CF, Session 5: Activity and lifestyle of CF patients, Session 6: Career and education future of CF patients. According to the sources and studies carried out in the field of group training for adolescents with cystic fibrosis, the research community will be divided into groups of 6 people in order to maintain safety and prevent infection, and according to the space of the training classes in the children's medical center, they will respect the distance. They sit at least 2 meters from each other in classes .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Respiratory Diseases Clinic, Children's Medical Center
Full name of responsible person
Dr. Mohammad Reza Modrasi
Street address
No. 62, Children's Medical Center Hospital, Dr. Gharib St., at the end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
cmcpr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Granmayeh
Street address
No. 62, School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani St., Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm-researchdeputy@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
medical University Tehran
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soraya Hossein pour
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 62, School of Nursing and Midwifery Tehran University of Medical Sciences, Mirkhani St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
hosseinpoorsoraya@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Jamaluddin Begjani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 62, School of Nursing and Midwifery Tehran University of Medical Sciences, Mirkhani St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6693 7120
Email
jamalbegjani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soraya Hossein pour
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 62, School of Nursing and Midwifery Tehran University of Medical Sciences, Mirkhani St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
hosseinpoorsoraya@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not 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
After deidentifying people, the overall results will be published in file format.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Research subjects and research team
Under which criteria data/document could be used
No other type of analysis is allowed by people other than the research team.
From where data/document is obtainable
Contact the project manager: Soraya Hosseinpour 09154902752
What processes are involved for a request to access data/document