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HBM-Based Education for Retinopathy of Prematurity Screening in Parents of Premature Infants

16 juin 2026 mis à jour par: Khadijah Abid, Aga Khan University

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

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

99

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Expérimental: 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.
Comparateur actif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Retinopathy of Prematurity Knowledge Score
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in HBM Perceptions Regarding ROP Screening
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

  • Chercheur principal: Khadijah Abid, Aga Khan University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 février 2027

Achèvement de l'étude (Estimé)

1 avril 2027

Dates d'inscription aux études

Première soumission

11 juin 2026

Première soumission répondant aux critères de contrôle qualité

16 juin 2026

Première publication (Réel)

22 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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