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

NCT07661654 | Not Yet Recruiting

• 1 other identifier: 2024-9718-29817
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Retinopathy of Prematurity (ROP)

Outcome Measures

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.

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

Secondary Outcomes (1)

• Change in HBM Perceptions Regarding ROP Screening

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

Study Arms (3)

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.

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.

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).

Behavioral: Standard Counselling and Pamphlet

Interventions

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.

Audio Message + Counselling + Pamphlet

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.

Counselling + Pamphlet (Control)

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.

Video Message + Counselling + Pamphlet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Parents with disability or cognitive impairment affecting participation
• Uncooperative participants
• Parents unwilling or unable to provide informed consent

Sponsors & Collaborators

• Aga Khan University: lead
• University of Alberta: collaborator

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Khadijah Abid

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khadijah Abid

CONTACT

+92-021-34930051; khadijah.abid@aku.edu

Fariha Ali

CONTACT

ali.fariha@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors responsible for evaluating study outcomes will remain blinded to participant group assignments. A separate assessment team not involved in intervention delivery and without access to the randomization list will conduct outcome assessments. Investigators delivering educational interventions will not be blinded due to the nature of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sr. Instructor (Research)

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share