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

16 giugno 2026 aggiornato da: 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

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

99

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Retinopathy of Prematurity Knowledge Score
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in HBM Perceptions Regarding ROP Screening
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Khadijah Abid, Aga Khan University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 aprile 2027

Date di iscrizione allo studio

Primo inviato

11 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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