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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAga Khan University

About this 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Parents with disability or cognitive impairment affecting participation

Uncooperative participants

Parents unwilling or unable to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • HBM-Based Video Education

    Behavioral

    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 Education

    Behavioral

    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 Pamphlet

    Behavioral

    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.

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: Video Message + Counselling + PamphletExperimental treatment 1 intervention
Group B: Audio Message + Counselling + PamphletExperimental treatment 1 intervention
Group C: Counselling + Pamphlet (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
Baseline to follow-up visit (approximately 2 weeks after initial visit)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aga Khan University

Lead sponsor

Aga Khan University Hospital, Pakistan

Sponsor institution

University of Alberta

Collaborator

This trial is not recruiting at the moment. You can still explore other options: