- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07654088
AI-Enabled Mobile App for Safe Eating in Older Adults With Dysphagia
Efficacy of an AI-enabled Mobile Application for Safe Eating in Community-dwelling Older Adults With Dysphagia: a Randomized Controlled 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 a smartphone application powered by artificial intelligence (AI) 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, and the app then estimates the texture level and provides guidance to help ensure it is safe to swallow. It also gives simple prompts to double-check food texture when needed.
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 16 weeks. Participants will continue their daily eating routines at home.
The main question this study is trying to answer is: Does using the AI-enabled mobile app improve how often people eat foods that match their recommended safe texture level compared with usual care alone?
The study will also examine whether the app helps reduce swallowing-related problems (such as choking), improves quality of life, and supports better overall eating ability. In addition, the study will evaluate how easy the app is to use and whether it places any burden on users.
Hypothesis: The researchers hypothesize that participants who use the AI-enabled app, in addition to usual care, will more consistently follow recommended food texture guidelines and experience safer eating compared with those who receive usual care alone.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 the lack of real-time feedback, variable caregiver skills, and difficulties in 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 alongside prompts encouraging 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 function within everyday meal preparation workflows, thereby targeting behavioral adherence at the point of consumption rather than relying solely on retrospective education.
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 period of active use, during which participants and/or caregivers may engage with the application during meal preparation, food purchase, 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 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 under a superiority framework to determine whether access to the AI-enabled tool results in 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 efficacy of dietary recommendations depends on their consistent and correct application in daily life.
In addition to assessing behavioral outcomes, the trial incorporates a multidimensional evaluation framework spanning symptom burden, functional oral intake, health-related quality of life, and safety events. 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. A subsample will undergo instrumental swallowing assessments to explore potential changes in swallowing physiology associated with improved adherence, thereby linking behavioral and mechanistic outcomes.
The study also integrates human-technology interaction considerations, including usability and perceived workload, to evaluate implementation feasibility and scalability. 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, as well as potential effect modifiers such as baseline functional status, cognitive factors, and living arrangements.
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 safe eating behaviors among community-dwelling older adults with dysphagia.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Anna Kam, AuD
- Numero di telefono: 852-29488194
- Email: annakam@eduhk.hk
Luoghi di studio
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Hong Kong, Hong Kong
- The Education University of Hong Kong
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Contatto:
- Anna Kam, AuD
- Numero di telefono: 852+29488194
- Email: annakam@eduhk.hk
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- 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
- Able to provide informed consent, or with caregiver support if mild cognitive impairment is present
- Access to a smartphone or tablet, either independently or with caregiver assistance
- Willing and able to participate in study procedures and follow-up assessments
Exclusion Criteria:
- 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
- Current participation in another dysphagia-related interventional study
- Use of other digital tools specifically designed for food texture classification during the study period
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: AI-Enabled Mobile Application plus Standard Care
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 |
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.
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Comparatore attivo: Standard Care Education
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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Proportion of Meals Adhering to Prescribed Texture Level
Lasso di tempo: Week 16
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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 |
Week 16
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Swallowing-Related Quality of Life
Lasso di tempo: Baseline, Week 16, Week 24
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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 |
Baseline, Week 16, Week 24
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Functional Oral Intake
Lasso di tempo: Baseline, Week 16, Week 24
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Functional oral intake will be assessed using the Functional Oral Intake Scale (FOIS), a 7-level ordinal scale. Change in the level of oral intake, reflecting the degree to which participants can consume food and liquids safely and independently. Scale Range: 1 to 7 Interpretation: Higher levels indicate better oral intake and less reliance on modified diets or non-oral feeding |
Baseline, Week 16, Week 24
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Incidence of Dysphagia-Related Adverse Events
Lasso di tempo: Baseline to Week 16; Week 16 to Week 24
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Incidence of swallowing-related safety events, including choking, near-choking episodes, emergency department visits, and hospitalizations associated with swallowing difficulties.
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Baseline to Week 16; Week 16 to Week 24
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mHealth App Usability Questionnaire (MAUQ) Score
Lasso di tempo: Week 16
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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 |
Week 16
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NASA Task Load Index (NASA-TLX) Global Score
Lasso di tempo: Week 16
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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 |
Week 16
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Score
Lasso di tempo: Baseline, Week 16
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Swallowing safety and efficiency will be assessed using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale during instrumental evaluation. Scale Range: 0 to 4 Interpretation: Higher scores indicate more severe swallowing impairment |
Baseline, Week 16
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Mobile Application Engagement (Usage Frequency)
Lasso di tempo: During the intervention period (Weeks 1-16)
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Engagement with the application will be measured by system-generated logs, including participant interaction with the mobile application, frequency of use, number of food scans performed, and response to system prompts. Measure Type / Units: Count (number of scans per participant) Interpretation: Higher values indicate greater engagement |
During the intervention period (Weeks 1-16)
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Response to Application Prompts
Lasso di tempo: Weeks 1-16
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Frequency of responses to application-generated prompts for texture verification will be recorded. Measure Type / Units: Count and proportion Interpretation: Higher values indicate greater interaction with system guidance |
Weeks 1-16
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International Dysphagia Diet Standardization Initiative (IDDSI) Adherence at Intermediate and Follow-Up Time Points
Lasso di tempo: Week 8, Week 24
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Changes in dietary adherence patterns at intermediate and follow-up time points will be measured to explore sustainability of behavior change. Proportion of meals adhering to prescribed IDDSI level at additional time points will be measured. All meals in the whole week 8 and week 24 will be included in the measurement. Measure Type / Units: Proportion (0-1 or 0-100%) Interpretation: Higher values indicate better adherence |
Week 8, Week 24
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Anna Kam, AuD, The Education University of Hong Kong
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Primo Inserito (Effettivo)
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Ultimo aggiornamento pubblicato (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- Disfagia
- Disturbi della deglutizione
- Adulti più anziani
- Disturbi della deglutizione
- Dieta modificata dalla consistenza
- Sistemi di supporto alle decisioni cliniche
- Invecchiamento della popolazione
- Intervento sanitario digitale
- Applicazioni sanitarie mobili
- Food texture assessment
- Artificial intelligence in health care
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025-2026-0777
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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