Retinopathy of Prematurity (ROP)NCT07661654
HBM-Based Education for Retinopathy of Prematurity Screening in Parents of Premature Infants
A study testing HBM-Based Video Education, HBM-Based Audio Education and Standard Counselling and Pamphlet in people with Retinopathy of Prematurity (ROP), run by Aga Khan University.
Trial summary
The goal of this clinical trial is to learn whether Health Belief Model (HBM)-based educational interventions can improve knowledge and practices related to Retinopathy of Prematurity (ROP) screening among parents of premature infants attending ROP clinics in Karachi, Pakistan. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- What is being tested?
- HBM-Based Video Education, HBM-Based Audio Education and Standard Counselling and Pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Apr 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mother or father of a premature infant attending Retinopathy of Prematurity (ROP) clinic
- Parent aged 18 years or older
- Parent of a premature infant who was admitted to the Neonatal Intensive Care Unit (NICU)
- Able to understand English or Urdu
- Willing and able to provide written informed consent
Who cannot join
- Parents with disability or cognitive impairment affecting participation
- Uncooperative participants
- Parents unwilling or unable to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Fariha Ali contact
About this study
Official title: Impact of Health Belief Model-Based Education on Retinopathy of Prematurity Screening Knowledge and Practices in Parents of Premature Infants: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether Health Belief Model (HBM)-based educational interventions can improve knowledge and practices related to Retinopathy of Prematurity (ROP) screening among parents of premature infants attending ROP clinics in Karachi, Pakistan. The main questions it aims to answer are:
- Do HBM-based educational interventions improve parents' knowledge about Retinopathy of Prematurity screening?
- Do HBM-based educational interventions improve parents' screening-related practices and follow-up for Retinopathy of Prematurity?
Read more
Researchers will compare different educational approaches, including video-based education, audio-based education, and standard educational material, to see which method is more effective in improving parental understanding and practices regarding ROP screening.
Participants will:
- Complete a questionnaire assessing their knowledge and practices related to Retinopathy of Prematurity screening at baseline
- Receive one of the following educational approaches: video message plus counselling and pamphlet, audio message plus counselling and pamphlet, or counselling and pamphlet only
- Attend a follow-up visit approximately 2 weeks after the initial visit
- Complete a follow-up questionnaire to assess changes in knowledge and practices related to Retinopathy of Prematurity screening
Read the detailed description
Retinopathy of Prematurity (ROP) is a retinal vascular disorder affecting premature infants and remains a leading preventable cause of childhood blindness worldwide. Premature infants, particularly those born before 37 weeks of gestation and with low birth weight, are at increased risk of developing ROP. Timely screening and follow-up are critical to prevent severe visual impairment; however, delayed presentation and poor adherence to follow-up appointments remain important barriers to effective management, especially in low- and middle-income countries.
Parental awareness and engagement are essential for ensuring timely screening and treatment. Conventional parental education methods, such as routine verbal communication and printed informational materials, may be limited by parental stress, health literacy, language barriers, and inconsistent access to healthcare information. Consequently, there is a need for evidence-based educational strategies that improve parental understanding and encourage timely health-seeking behavior.
The Health Belief Model (HBM) provides a theoretical framework for understanding and promoting preventive health behaviors by addressing perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action. Applying this framework to parent education may improve awareness regarding the risks of untreated ROP and the importance of screening and follow-up.
This randomized controlled trial will evaluate the effectiveness of Health Belief Model-based educational interventions for parents of premature infants attending Retinopathy of Prematurity clinics at Aga Khan University Hospital, Karachi, Pakistan. The study compares multiple educational delivery methods integrated into routine clinical care to determine whether structured educational approaches can improve parental understanding and engagement in ROP screening.
Educational materials have been developed by the Department of Ophthalmology and Visual Sciences and are available in English and Urdu to improve accessibility and cultural appropriateness. Findings from this study are expected to inform strategies for strengthening parental education and improving neonatal ophthalmic care in resource-limited settings.
- Conditions
- Retinopathy of Prematurity (ROP)
- Being tested
- HBM-Based Video Education, HBM-Based Audio Education, Standard Counselling and Pamphlet
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBM-Based Video EducationBehavioural
Participants will receive a Health Belief Model-based educational video regarding Retinopathy of Prematurity (ROP), including information on disease development, risk factors, importance of timely screening, treatment options, and follow-up. Counselling by an ophthalmologist and a user-friendly pamphlet in English or Urdu will also be provided.
HBM-Based Audio EducationBehavioural
Participants will receive a Health Belief Model-based educational audio message regarding Retinopathy of Prematurity (ROP), including information on disease development, risk factors, importance of timely screening, treatment options, and follow-up. Counselling by an ophthalmologist and a user-friendly pamphlet in English or Urdu will also be provided.
Standard Counselling and PamphletBehavioural
Participants will receive standard educational information through counselling by an ophthalmologist and a user-friendly pamphlet regarding Retinopathy of Prematurity (ROP). Educational materials will be provided in English or Urdu.
| Study group | Role | What they receive |
|---|---|---|
| Video Message + Counselling + Pamphlet | Experimental | Participants will receive a Health Belief Model-based educational video regarding Retinopathy of Prematurity (ROP), along with counselling by an ophthalmologist and a user-friendly educational pamphlet in English or Urdu. Receives: Behavioral: HBM-Based Video Education |
| Audio Message + Counselling + Pamphlet | Experimental | Participants will receive a Health Belief Model-based educational audio message regarding Retinopathy of Prematurity (ROP), along with counselling by an ophthalmologist and a user-friendly educational pamphlet in English or Urdu. Receives: Behavioral: HBM-Based Audio Education |
| Counselling + Pamphlet (Control) | Active comparator | Participants will receive standard educational information through counselling by an ophthalmologist and a user-friendly educational pamphlet regarding Retinopathy of Prematurity (ROP). Receives: Behavioral: Standard Counselling and Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Retinopathy of Prematurity Knowledge Score
Knowledge regarding Retinopathy of Prematurity (ROP) will be assessed using a structured 10-item ROP Knowledge Questionnaire completed by parents. Items assess knowledge related to ROP risk factors, screening, treatment, and complications. Correct responses receive a score of 1 and incorrect or "I do not know" responses receive a score of 0. Total scores range from 0 to 10, with higher scores indicating better knowledge. Change in total score will be assessed by comparing baseline and follow-up questionnaire scores.
Measured: Baseline to follow-up visit (approximately 2 weeks after initial visit)
Secondary outcomes (1)
Change in HBM Perceptions Regarding ROP Screening
Parental perceptions regarding Retinopathy of Prematurity (ROP) screening will be assessed using a structured Health Belief Model (HBM)-Based ROP Screening Questionnaire evaluating perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy. Questionnaire items are measured using a 5-point Likert scale ranging from 1 to 5, with higher scores indicating stronger agreement with positive health beliefs related to ROP screening. Change in questionnaire scores will be assessed between baseline and follow-up.
Measured: Baseline to follow-up visit (approximately 2 weeks after initial visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of Prematurity (ROP)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of three parallel groups to receive Health Belief Model-based educational interventions related to Retinopathy of Prematurity (ROP). Group 1 will receive a video message, counselling, and a user-friendly pamphlet; Group 2 will receive an audio message, counselling, and a user-friendly pamphlet; and Group 3 (control) will receive counselling and a user-friendly pamphlet only. Participants will remain in their assigned group throughout the study period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Responsible party
- Principal investigator, Khadijah Abid, Aga Khan University Hospital, Pakistan
- Investigators
- Khadijah Abid, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661654
- Sponsor's protocol ID
- 2024-9718-29817
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to participant confidentiality considerations and institutional data protection policies. The study involves questionnaire-based data collected from parents of premature infants, and no formal data-sharing agreement or repository is planned as part of the approved study protocol.