AI-Enabled Mobile App for Safe Eating in Older Adults With Dysphagia

ConditionsDeglutition Disorders Dysphagia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60+

SponsorKAM Chi Shan Anna

About this trial

Difficulty swallowing (called dysphagia) is common in older adults and can make eating and drinking unsafe. It may lead to serious problems such as choking, lung infections, poor nutrition, and reduced quality of life. One common way to reduce these risks is to modify food and drink textures (for example, making foods softer or liquids thicker). However, people often find it difficult to prepare food at the correct texture level in everyday life, especially at home, which may reduce the effectiveness of this approach.

This study aims to test whether an artificial intelligence (AI)- powered smartphone application can help older adults with swallowing difficulties eat more safely. The app allows users (or their caregivers) to take a photo of food or drinks, then estimates the texture level and provides guidance to help them follow their recommended food texture level. It also gives simple prompts to double-check food texture when needed. The app is intended as a decision-support tool and does not replace clinical advice or prescribed dietary recommendations.

In this clinical trial, community-dwelling adults aged 60 years or above with swallowing difficulties will be randomly assigned to one of two groups. One group will receive usual care, which includes education about safe swallowing and written instructions on appropriate food textures. The other group will receive the same usual care plus access to the AI-enabled mobile app for 12 weeks. Participants will continue their daily eating routines at home. Participants will also be followed for an additional 8 weeks after the 12-week intervention period.

The main question this study aims to answer is: Does using the AI-enabled mobile app increase the frequency with which people eat foods that match their recommended safe texture level compared with usual care alone? This will be assessed at Week 12 using a structured 3-day dietary record and accompanying meal photographs.

The study will also examine whether the app helps reduce swallowing-related symptoms and adverse events, improves swallowing-related quality of life, and increases confidence in managing swallowing difficulties. In addition, the study will evaluate how easy the app is to use and whether it places any burden on users.

Hypothesis: Participants who use the AI-enabled app, in addition to usual care, will more consistently follow recommended food texture guidelines than those who receive usual care alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 60 years or above

Community-dwelling (living in a home or community setting)

Suspected or clinically identified oropharyngeal dysphagia

Currently consuming food or liquids orally at texture-modified levels

Disqualifiers

Exclusive dependence on non-oral feeding (e.g., tube feeding)

Severe cognitive impairment or severe visual impairment that prevents meaningful participation

Medical conditions or circumstances that make participation unsafe

Life expectancy less than 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

AI-Enabled Mobile Application plus Standard Care
Device
A smartphone-based application that uses artificial intelligence to classify food and liquid textures from images captured by the user. The application provides real-time guidance aligned with standardized dysphagia diet levels and delivers safety-focused prompts to verify texture using simple methods when needed. The tool is designed to support safe meal preparation and improve adherence to prescribed texture-modified diets in daily home settings. Participants receive onboarding and use the application during meals throughout the intervention period.
Standard Dysphagia Education
Behavioral
A structured education session providing guidance on safe swallowing practices and preparation of texture-modified foods and liquids. Participants receive printed educational materials describing appropriate food textures and simple methods for checking consistency. This reflects usual care in community dysphagia management and does not include digital or automated decision support.

Treatment groups

332 Participants

are divided into 2 treatment groups

Group A: AI-Enabled Mobile Application plus Standard CareExperimental treatment 1 intervention

Group B: Standard Care EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Proportion of Meals Adhering to Prescribed Texture Level

The participant-level proportion of meals that correctly match the prescribed food and liquid texture level, based on standardized dysphagia diet guidelines, during a defined assessment period. In the intervention group, classification is supported by the mobile application and verification procedures; in the control group, adherence is determined using structured dietary logs with verification. Measure Type / Units: Proportion (0 to 1, or percentage 0-100%) Interpretation: Higher values indicate better adherence to prescribed diet texture

Time frame

Baseline, Week12, 20

Secondary outcomes

Swallowing-Related Quality of Life

Swallowing-related quality of life measured using the Swallowing Quality of Life Questionnaire (SWAL-QOL). Domains include physical, emotional, and social aspects of eating and drinking. Scale Range: 0 to 100 Interpretation: Higher scores indicate better quality of life

Time frame

Baseline, Week 12, Week 20

Dysphagia symptom severity

Dysphagia symptom severity will be measured using the Eating Assessment Tool (EAT 10), a 10-item patient-reported questionnaire assessing swallowing-related symptoms. Each item is rated on a 5-point scale from 0 ("no problem") to 4 ("severe problem"), yielding a total score ranging from 0 to 40. Higher total scores indicate greater perceived swallowing difficulty, whereas lower scores indicate fewer swallowing-related symptoms. Scale Range: 0 to 40 Interpretation: A decrease in EAT-10 score from baseline therefore indicates improvement, while an increase indicates worsening of symptoms.

Time frame

Baseline, Week 6, 12, 20

Incidence of Dysphagia-Related Adverse Events

Incidence of swallowing-related safety events, including choking, near-choking episodes, emergency department visits, and hospitalizations associated with swallowing difficulties.

Time frame

Baseline to Week 12; Week 12 to Week 20

mHealth App Usability Questionnaire (MAUQ) Score

Usability of the mobile application will be assessed using the mHealth App Usability Questionnaire (MAUQ). User-reported usability of the mobile application, including ease of use, usefulness, and satisfaction, will be assessed. Scale Range: Typically 1 to 7 per item (mean total score reported) Interpretation: Higher scores indicate better usability

Time frame

Week 12

Other outcomes

Dysphagia Management Self--Efficacy

Dysphagia management self-efficacy will be assessed using an 8-item questionnaire developed based on Bandura's self-efficacy framework. Participants, or the primary caregiver responsible for meal preparation, will rate their confidence in performing dysphagia-management tasks (e.g., identifying appropriate food textures, modifying foods to the prescribed IDDSI level, and recognizing unsafe foods) on an 11-point scale from 0 ("cannot do at all") to 10 ("highly certain can do"). Score range: 0 - 80 Interpretation: Higher values indicate greater self-efficacy

Time frame

Baseline, Week 6, 12, 20

Sponsors and contacts

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

KAM Chi Shan Anna

Lead sponsor

Education University of Hong Kong

Sponsor institution

Source ClinicalTrials.gov

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