Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Alberta | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khadijah Abid | Contact | +92-021-34930051 | khadijah.abid@aku.edu | |
| Fariha Ali | Contact | ali.fariha@aku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Khadijah Abid | Aga Khan University | Principal Investigator |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
| 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. |
|
| Baseline to follow-up visit (approximately 2 weeks after initial visit) |
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |