An interventional study of AI-Enabled Mobile Application plus Standard Care and Standard Dysphagia Education in Deglutition Disorders and Dysphagia, sponsored by KAM Chi Shan Anna. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by KAM Chi Shan Anna · Not applicable, Interventional, and Treatment
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.
Dysphagia (swallowing impairment) is a highly prevalent condition in older adults and is associated with increased risks of aspiration, malnutrition, dehydration, and reduced quality of life. While the International Dysphagia Diet Standardization Initiative (IDDSI) framework provides standardized terminology and practical methods for modifying food and liquid textures, ensuring accurate and consistent adherence to prescribed texture levels remains challenging in community settings. In particular, adherence is often limited by a lack of real-time feedback, variable caregiver skills, and difficulty verifying food texture during routine meal preparation.
This study evaluates a novel, implementation-oriented digital health intervention designed to address these barriers. The intervention is an AI-enabled mobile application that supports real-time classification of food and liquid textures using smartphone-based image capture. The application incorporates a safety-first decision logic, providing conservative classification outputs and prompts that encourage users to verify textures using established IDDSI field tests (e.g., flow test, fork pressure test) when classification uncertainty is detected. The system is designed to operate within everyday meal-preparation workflows, thereby targeting behavioral adherence at the point of consumption rather than relying solely on retrospective education. The application is intended as a decision-support tool and does not replace clinician judgment or prescribed dietary recommendations.
The trial adopts a pragmatic, community-based randomized controlled design to assess real-world effectiveness under typical home-use conditions. The intervention is delivered over a defined 12-week period of active use, during which participants and/or caregivers may engage with the application during meal preparation or consumption. The application records usage metrics (e.g., frequency of image captures, classification outputs, and uncertainty prompts), enabling evaluation of engagement and fidelity. The intervention is supported by structured onboarding and ongoing technical support to ensure usability among older adults and their caregivers. The 12-week intervention period is followed by an 8-week follow-up period, resulting in a total study period of 20 weeks per participant.
The comparator reflects current standard practice in community dysphagia management and allows evaluation of the incremental benefit of digital decision support beyond education alone. The study is designed within a superiority framework to determine whether access to the AI-enabled tool leads to meaningful improvements in behavioral adherence, which is considered the proximal mechanism linking dietary modification to downstream clinical outcomes. By focusing on adherence as the primary target, the study aligns with an implementation science perspective, recognizing that the efficacy of dietary recommendations depends on their consistent and correct application in daily life.
The primary outcome is adherence to the clinician-prescribed IDDSI dietary recommendation at Week 12. Adherence will be assessed using a structured 3-day dietary record and accompanying meal photographs collected over two weekdays and one weekend day within the assessment week. A speech-language pathologist blinded to group allocation will review the dietary records and meal photographs and determine whether each meal is consistent with the participant's prescribed IDDSI level. Participant-level adherence will be calculated as the number of adherent meals divided by the total number of meals recorded. Adherence will also be assessed at Week 20 to evaluate maintenance of any intervention effects.
In addition to assessing behavioral outcomes, the trial incorporates a multidimensional evaluation framework spanning dysphagia symptom severity, swallowing-related quality of life, dysphagia-related adverse events, and dysphagia management self-efficacy. These domains provide a comprehensive understanding of both intended benefits and potential unintended consequences, including risks related to misclassification, over-reliance on automated guidance, or increased user burden.
The study also integrates human-technology interaction considerations, including usability and perceived workload, to evaluate the feasibility and scalability of implementation. App usability will be evaluated using the mHealth App Usability Questionnaire (MAUQ), and perceived workload associated with app use will be assessed using the NASA Task Load Index (NASA-TLX) at Week 12 in the intervention arm. These measures are important for determining whether the intervention can be sustainably adopted in routine practice, particularly among older populations with varying levels of digital literacy.
From an analytical perspective, the trial is designed to estimate real-world effectiveness using an intention-to-treat framework, capturing the impact of offering the intervention under typical conditions rather than ideal adherence scenarios. Exploratory analyses will examine associations between engagement metrics and clinical outcomes.
This research addresses a critical gap in dysphagia care by evaluating a scalable, technology-assisted approach that operationalizes standardized dietary guidelines in real-world settings. It also contributes to the emerging field of AI in healthcare by providing rigorous evidence from a randomized controlled trial conducted outside of highly controlled clinical environments. The findings are expected to inform both clinical practice and public health strategies aimed at improving adherence to recommended food textures and supporting safer eating behaviors among community-dwelling older adults with dysphagia.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 332 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →This is the only study on the registry with KAM Chi Shan Anna as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive access to an artificial intelligence-enabled mobile application designed to support real-time classification of food and liquid textures according to standardized dysphagia diet levels. The application provides safety-oriented guidance and prompts for verification of food texture during daily meal preparation and consumption. Participants also receive standard dysphagia education materials and training. The intervention is used in a home setting over the study period to support adherence to prescribed dietary recommendations. Intervention used: AI-Enabled Mobile Application plus Standard Care
Device: AI-Enabled Mobile Application plus Standard Care
Participants receive standard dysphagia education, including guidance on safe swallowing practices and instructions for preparing texture-modified foods and liquids. Educational materials and training are provided, reflecting usual community care. No digital or application-based decision support is provided.
Behavioral: Standard Dysphagia Education
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.
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.
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
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
NASA Task Load Index (NASA-TLX) Global Score
Perceived workload associated with app use will be assessed using the NASA Task Load Index (NASA-TLX). Participant-reported mental and physical workload associated with using the mobile application during daily activities will be measured. Scale Range: 0 to 100 Interpretation: Higher scores indicate greater perceived workload
Time frame: Week 12
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
Plan to share: No — Individual participant data will not be shared due to data privacy considerations and institutional data protection policies. De-identified, aggregate results will be reported in publications and presentations, and summaries of findings may be made available upon reasonable request.
No publications or documents are linked to this record.
Start is estimated for Jan 2028; primary completion for Dec 2030, 35 months later.
Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 35 months is above that.
Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.