HBM-Based Education for Retinopathy of Prematurity Screening in Parents of Premature Infants
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?
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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Khadijah Abid
- Telefoonnummer: +92-021-34930051
- E-mail: khadijah.abid@aku.edu
Studie Contact Back-up
- Naam: Fariha Ali
- E-mail: ali.fariha@aku.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- Parents with disability or cognitive impairment affecting participation
- Uncooperative participants
- Parents unwilling or unable to provide informed consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Video Message + Counselling + Pamphlet
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.
|
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.
|
|
Experimenteel: Audio Message + Counselling + Pamphlet
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.
|
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.
|
|
Actieve vergelijker: Counselling + Pamphlet (Control)
Participants will receive standard educational information through counselling by an ophthalmologist and a user-friendly educational pamphlet regarding Retinopathy of Prematurity (ROP).
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Retinopathy of Prematurity Knowledge Score
Tijdsspanne: Baseline to follow-up visit (approximately 2 weeks after initial visit)
|
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.
|
Baseline to follow-up visit (approximately 2 weeks after initial visit)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in HBM Perceptions Regarding ROP Screening
Tijdsspanne: Baseline to follow-up visit (approximately 2 weeks after initial visit)
|
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.
|
Baseline to follow-up visit (approximately 2 weeks after initial visit)
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Khadijah Abid, Aga Khan University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2024-9718-29817
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
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