Easy-to-Read Content Effectiveness Evaluation

NCT07036575 | Recruiting

• 1 other identifier: 202504004RINA
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with intellectual disabilities face challenges in accessing medical services and health education due to communication barriers and limited support tools. Traditional information delivery methods often fail to meet their needs, leading to unequal access to preventive care and early screening. This integrated program aims to promote visual health among individuals with intellectual disabilities through the development and implementation of inclusive technologies. The program consists of three sub-projects:

1. 1.Visual Health Promotion and Development of an Inclusive Information Platform for Individuals with Intellectual Disabilities - developing accessible health materials for individuals with intellectual disabilities and their families.
2. 2.Development and Promotion of a Digital Visual Health Screening System for Individuals with Intellectual Disabilities - designed to support early detection and intervention tailored to this population.
3. 3.Development of a Healthcare Access Platform and Assistive Technologies for Individuals with Intellectual Disabilities - reducing communication barriers during medical visits through technological support.

Conditions

Health Knowledge; Intellectual Developmental Disorder; Visual Impairment

Keywords

Easy-to-Read; intellectal disability; children; special needs; visual impairment; vision health education

Outcome Measures

Primary Outcomes (1)

• Test of basic eye health knowledge Knowledge

  This 8-question test assesses basic eye health knowledge. Each item has two stages: an open question (2 points if correct), followed by a yes/no question (1 point if correct) if the first is incorrect. It is given before and after the health education to measure learning outcomes.

  3 months

Study Arms (3)

General Health Education Group

ACTIVE COMPARATOR

Participants in this group receive standard health education using conventional visually-based educational materials (e.g., children's book) related to eye care. A trained instructor explains each image using a structured script designed for general comprehension.

Behavioral: Standard Visual Health Education

Easy-to-Read Guided Teaching Group

EXPERIMENTAL

Participants in this group receive health education using an Easy-to-Read version of the materials, consisting of 16 simplified images with pictorial supports and plain-language text. The instruction is delivered one-on-one by a trained educator following a scripted guide optimized for individuals with intellectual or developmental disabilities.

Behavioral: Easy-Read Instructor-Guided Education

Easy-to-Read Audio Self-Learning Group

EXPERIMENTAL

Participants in this group receive the same Easy-to-Read materials as Arm 2, but instead of guided teaching, they are instructed to operate a voice-assisted pen device to independently play back pre-recorded audio explanations linked to each image. A researcher supervises the interaction to ensure the device is used correctly, but no additional explanation is provided.

Behavioral: Easy-Read Audio-Based Self-Learning

Interventions

Standard Visual Health Education BEHAVIORAL

Participants receive conventional eye health education using standard visual materials, explained by an instructor.

General Health Education Group

Easy-Read Instructor-Guided Education BEHAVIORAL

Participants receive Easy-Read health education through 16 simplified images with instructor-guided explanation using plain language and pictorial content.

Easy-to-Read Guided Teaching Group

Easy-Read Audio-Based Self-Learning BEHAVIORAL

Participants use a voice-assisted pen device to self-learn Easy-Read materials (16 images) with audio explanations, without additional teacher guidance.

Easy-to-Read Audio Self-Learning Group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and adolescents aged 3 to under 18
• Children and adolescents with intellectual disabilities and developmental delays.
• Children and adolescents who are able to correctly identify at least two out of the three images in the pre-assessment phase.

You may not qualify if:

• Severe cognitive impairments, hearing impairments, speech disorders, or motor disabilities that would interfere with assessment procedures or participation in the instructional activities.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Health and Welfare, Taiwan: collaborator

Study Sites (1)

Intellectual and developmental disability centers and related institutions

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Intellectual Disability; Vision Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Sensation Disorders; Eye Diseases

Study Officials

• Li-Ting Tsai

  National Taiwan University

  STUDY CHAIR

Central Study Contacts

Li-Ting Tsai

CONTACT

886-2-3366-8164; litingtsai@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)