The School-Age Children With Cystic Fibrosis and Their Parents on Health Literacy

NCT07304362 | Recruiting

• 1 other identifier: duygudemir KF Burcu
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled experimental study is planned to examine the effect of an online education program provided to school-age children aged 6-11 years diagnosed with cystic fibrosis and their parents on health literacy levels. 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.

Conditions

Cystic Fibrosis (CF)

Keywords

cystic fibrosis; Health Literacy; Chronic Disease; School-Age Child

Outcome Measures

Primary Outcomes (2)

• Children's health literacy levels

  Will be assessed using the Health Literacy Scale for School-Age Children, indicating the child's ability to understand, interpret, and apply health information.

  4 weeks after the intervention

• Parents' health literacy levels

  Will be measured via the Turkey Health Literacy Scale-32 to assess parents' ability to understand, interpret, and apply health-related information.

  4 weeks after the intervention

Study Arms (2)

Online Education Group

EXPERIMENTAL

Behavioral: Online Education Program

Control Group

NO INTERVENTION

Children in the control group will receive only routine follow-up and standard care. No additional intervention will be provided to this group.

Interventions

Online Education Program BEHAVIORAL

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.

Online Education Group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-11 years at the time of the study.
• 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.

You may not qualify if:

• Children with severe visual, auditory, or cognitive impairments that would prevent them from understanding or completing the scales.
• 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.

Sponsors & Collaborators

• University of Yalova: lead

Study Sites (1)

Yalova Universty

Yalova, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Cordeiro SM, da Silva HB, Silva-Rodrigues FM. Family caregivers' needs for information on pediatric cystic fibrosis: A qualitative study. J Child Health Care. 2026 Mar;30(1):50-63. doi: 10.1177/13674935241303539. Epub 2024 Nov 26.

  PMID: 39589857 BACKGROUND

• 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.

  PMID: 39383558 BACKGROUND

• 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.

  PMID: 36684859 BACKGROUND

• 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.

  PMID: 23269367 BACKGROUND

• 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.

  PMID: 32660459 RESULT

• 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.

  PMID: 38989817 RESULT

• 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.

  PMID: 28441934 RESULT

MeSH Terms

Conditions

Cystic Fibrosis; Chronic Disease

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

DUYGU DEMİR Associate Professor

CONTACT

+905053662358; duygu.demir@yalova.edu.tr

BURCU UZUNOĞLU

CONTACT

+905542406344; burcusuzer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN

Model Details: The study is planned to be conducted as a randomized controlled experimental design with a pretest-posttest structure. The research will consist of two groups: an intervention group receiving the online education program and a control group receiving no additional intervention.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 26, 2025
• Study Start: June 10, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)