Cystic Fibrosis (CF)NCT07304362
The School-Age Children With Cystic Fibrosis and Their Parents on Health Literacy
A study testing Online Education Program in people with Cystic Fibrosis (CF), run by University of Yalova at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- Online Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to School-Age Children With Cystic Fibrosis and Their Parents on Health Literacy Levels
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.
Read the detailed description
The study population will consist of school-age children aged 6-11 years who are diagnosed with cystic fibrosis and meet the inclusion criteria, along with their parents, followed at the Cystic Fibrosis Outpatient Clinic of Marmara University Pendik Training and Research Hospital.
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
- Cystic Fibrosis (CF)
- Being tested
- Online Education Program
- Keywords
- cystic fibrosis, Health Literacy, Chronic Disease, School-Age Child
- Medical subject headings
- Cystic Fibrosis, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online Education Group | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start10 May 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Demir, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304362
- Sponsor's protocol ID
- duygudemir KF Burcu
- Status last verified
- May 2026
- First submitted
- 28 Nov 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39589857Yuksek 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.
PubMed 39383558Ahmadpour 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.
PubMed 36684859McDonald 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.
PubMed 23269367de 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.
PubMed 32660459Li 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.
PubMed 38989817Broder 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.
PubMed 28441934
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to School-Age Children With Cystic Fibrosis and Their Parents on Health Literacy Levels
- ClinicalTrials.gov ID
- NCT07304362
- Acronym / sponsor ID
- duygudemir KF Burcu
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- cystic fibrosis, Health Literacy, Chronic Disease, School-Age Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 10 May 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study population will consist of school-age children aged 6-11 years who are diagnosed with cystic fibrosis and meet the inclusion criteria, along with their parents, followed at the Cystic Fibrosis Outpatient Clinic of Marmara University Pendik Training and Research Hospital.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Education ProgramChildren 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. | Behavioural | Online Education Group |
Primary outcome
Children's health literacy levels
Time frame: 4 weeks after the intervention
Will be assessed using the Health Literacy Scale for School-Age Children, indicating the child's ability to understand, interpret, and apply health information.
Parents' health literacy levels
Time frame: 4 weeks after the intervention
Will be measured via the Turkey Health Literacy Scale-32 to assess parents' ability to understand, interpret, and apply health-related information.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 39589857Cordeiro 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.
- Background: PubMed 39383558Yuksek 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.
- Background: PubMed 36684859Ahmadpour 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.
- Background: PubMed 23269367McDonald 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.
- Results publication: PubMed 32660459de 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.
- Results publication: PubMed 38989817Li 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.
- Results publication: PubMed 28441934Broder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Education Program in people with Cystic Fibrosis (CF), run by University of Yalova at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's health literacy levels (time frame: 4 weeks after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07304362, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.