The School-Age Children With Cystic Fibrosis and Their Parents on Health Literacy
NCT ID: NCT07304362
Last Updated: 2025-12-26
Study Results
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Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2025-06-10
2026-06-01
Brief Summary
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The study population will consist of 123 school-age children with cystic fibrosis and their parents who are followed at the Cystic Fibrosis Outpatient Clinic of Marmara University Pendik Training and Research Hospital. The study sample will include 104 children and their parents, who will be randomly assigned to either the intervention group (n = 52) or the control group (n = 52).
Data will be collected using the Introductory Information Form, the Health Literacy Scale for School-Age Children, and the Turkey Health Literacy Scale-32. Following the pre-test assessments, an online education program developed by the researcher will be delivered to the intervention group. The control group will not receive any additional intervention. Both groups will complete post-test assessments four weeks after the pre-test.
Detailed Description
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This study is planned to be designed as a randomized controlled experimental study with a pretest-posttest design in order to determine the effect of an online education program that will be delivered to children with cystic fibrosis and their parents on health literacy levels. The study will aim to evaluate parents' ability to understand, evaluate, and use health information accurately, as well as children's understanding of their disease, their responsibility in managing their health, and the development of healthy lifestyle behaviors.
To ensure homogeneous distribution of the groups, randomization will be performed using a computer-based system (http://www.randomization.com, balanced permutation method). Children who meet the inclusion criteria and whose parents provide consent will be randomly assigned to either the intervention group or the control group according to the randomization list.
The online education program, developed by the researcher, will be administered to the intervention group following the pretest. The control group will not receive any additional intervention. Both groups will complete posttest assessments four weeks after the pretest.
Study Variables
• Independent Variable: The independent variable of the study will be the online education program that will be delivered to school-age children with cystic fibrosis and their parents.
• Dependent Variables: The dependent variables will be the health literacy levels of children diagnosed with cystic fibrosis and their parents.
• Control Variables: The control variables will include the descriptive characteristics of the children (age, gender).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Online Education Group
Online Education Program
Children with cystic fibrosis and their parents in the intervention group will receive an online education program designed to improve health literacy. The program will be delivered once, immediately after the pretest, through an online platform. The session will last approximately 30-40 minutes and will follow a standardized educational protocol reviewed by expert faculty members. Posttest assessment will be conducted 4 weeks after the intervention. The program aims to enhance parents' ability to interpret, apply, and make decisions based on health information, and to help children understand and take responsibility for their own health.
Control Group
Children in the control group will receive only routine follow-up and standard care. No additional intervention will be provided to this group.
No interventions assigned to this group
Interventions
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Online Education Program
Children with cystic fibrosis and their parents in the intervention group will receive an online education program designed to improve health literacy. The program will be delivered once, immediately after the pretest, through an online platform. The session will last approximately 30-40 minutes and will follow a standardized educational protocol reviewed by expert faculty members. Posttest assessment will be conducted 4 weeks after the intervention. The program aims to enhance parents' ability to interpret, apply, and make decisions based on health information, and to help children understand and take responsibility for their own health.
Eligibility Criteria
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Inclusion Criteria
Children receiving treatment at the Cystic Fibrosis Diagnosis and Treatment Center during the study period.
Children able to understand and complete the Health Literacy Scales (no visual, auditory, or cognitive impairments that would prevent scale completion).
Children with sufficient proficiency in Turkish to answer the scales.
Children and parents who voluntarily agree to participate.
Children who have not previously received any health literacy education.
Exclusion Criteria
Children who have already received health literacy education.
Children who are outside the age range of 6-11 years.
Children not receiving follow-up at the Cystic Fibrosis Diagnosis and Treatment Center during the study period.
6 Years
11 Years
ALL
Yes
Sponsors
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University of Yalova
OTHER
Responsible Party
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Duygu Demir
PhD, RN
Locations
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Yalova Universty
Yalova, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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DUYGU DEMİR, Assistant Professor
Role: primary
References
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Cordeiro SM, da Silva HB, Silva-Rodrigues FM. Family caregivers' needs for information on pediatric cystic fibrosis: A qualitative study. J Child Health Care. 2024 Nov 26:13674935241303539. doi: 10.1177/13674935241303539. Online ahead of print.
Yuksek BN, Ayaz-Alkaya S. Effectiveness of health literacy education on health literacy in early adolescence: A randomized controlled trial. Public Health. 2024 Dec;237:135-140. doi: 10.1016/j.puhe.2024.09.024. Epub 2024 Oct 9.
Ahmadpour M, Omidvar N, Shakibazadeh E, Doustmohammadian A, Rahimiforoushani A. Development and evaluation of an intervention to improve food and nutrition literacy among Iranian Kurdish primary school children: An application of intervention mapping approach. Front Public Health. 2023 Jan 4;10:1059677. doi: 10.3389/fpubh.2022.1059677. eCollection 2022.
McDonald CM, Haberman D, Brown N. Self-efficacy: empowering parents of children with cystic fibrosis. J Cyst Fibros. 2013 Sep;12(5):538-43. doi: 10.1016/j.jcf.2012.11.014. Epub 2012 Dec 24.
de Buhr E, Tannen A. Parental health literacy and health knowledge, behaviours and outcomes in children: a cross-sectional survey. BMC Public Health. 2020 Jul 13;20(1):1096. doi: 10.1186/s12889-020-08881-5.
Li Y, Xiao Q, Chen M, Jiang C, Kang S, Zhang Y, Huang J, Yang Y, Li M, Jiang H. Improving Parental Health Literacy in Primary Caregivers of 0- to 3-Year-Old Children Through a WeChat Official Account: Cluster Randomized Controlled Trial. JMIR Public Health Surveill. 2024 Jul 4;10:e54623. doi: 10.2196/54623.
Broder J, Okan O, Bauer U, Bruland D, Schlupp S, Bollweg TM, Saboga-Nunes L, Bond E, Sorensen K, Bitzer EM, Jordan S, Domanska O, Firnges C, Carvalho GS, Bittlingmayer UH, Levin-Zamir D, Pelikan J, Sahrai D, Lenz A, Wahl P, Thomas M, Kessl F, Pinheiro P. Health literacy in childhood and youth: a systematic review of definitions and models. BMC Public Health. 2017 Apr 26;17(1):361. doi: 10.1186/s12889-017-4267-y.
Other Identifiers
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duygudemir KF Burcu
Identifier Type: -
Identifier Source: org_study_id