Talking Pen Audio-Interactive Program for Oral Frailty Delay in Community-Dwelling Elderly

Not Applicable

Not yet recruiting

• Conditions: Oral Health of Older Men

• Registration Number: NCT07191600
• Lead Sponsor: Chang Gung University of Science and Technology

Brief Summary

This study aims to develop and evaluate the effectiveness of a talking pen audio-interactive technology integrated with an oral frailty delay care program for community-dwelling older adults in rural agricultural regions of Chiayi County, Taiwan. The intervention is designed to improve oral function, physical health, and mental well-being. Bilingual (Mandarin and Taiwanese) teaching materials on oral frailty care will be developed. Usability and satisfaction testing will be conducted with older adults at local community bases. A quasi-experimental design will be implemented with 10 participants, who will be randomly assigned to an intervention group or a control group. The intervention group will receive the oral frailty care program with talking pen audio-interactive technology, while the control group will continue with regular community activities. Outcomes, including oral function, physical performance, and mental health, will be measured at baseline, 3 months, and 6 months. This study seeks to provide evidence for innovative, accessible, and sustainable approaches to oral frailty prevention in rural elderly populations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-29
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• Study Start: 2026-01-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adults aged 65 years or older residing in community settings of Chiayi County.
• Able to perform basic self-care.
• No severe swallowing difficulties and not dependent on nasogastric tube feeding.
• Clear consciousness and able to communicate in Mandarin or Taiwanese.
• Willing to provide written informed consent and participate in the study.

Exclusion Criteria

• Individuals not residing in Chiayi County communities.
• Individuals unable to perform activities of daily living independently or with impaired consciousness.
• Individuals with cognitive impairment or psychiatric disorders that prevent cooperation with study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Anterior Tongue Pressure	Baseline, 3 months, and 6 months	Maximum tongue pressure at the anterior tongue will be assessed using the Iowa Oral Performance Instrument (IOPI). Each participant will perform 3 trials with 1-2 minutes rest between trials. The maximum value across 3 trials will be recorded as Pmax.
Change in Posterior Tongue Pressure (Pmax)	Baseline, 3 months, and 6 months.	Maximum tongue pressure at the posterior tongue will be assessed using the Iowa Oral Performance Instrument (IOPI). Each participant will perform 3 trials with 1-2 minutes rest between trials. The maximum value across 3 trials will be recorded as Pmax.
Change in Lip Muscle Pressure (Pmax)	Baseline, 3 months, and 6 months.	Maximum tongue pressure at the lip muscles will be assessed using the Iowa Oral Performance Instrument (IOPI). Each participant will perform 3 trials with 1-2 minutes rest between trials. The maximum value across 3 trials will be recorded as Pmax.
Change in Orbicularis Oris Pressure (Pmax)	Baseline, 3 months, and 6 months.	Maximum tongue pressure at the orbicularis oris will be assessed using the Iowa Oral Performance Instrument (IOPI). Each participant will perform 3 trials with 1-2 minutes rest between trials. The maximum value across 3 trials will be recorded as Pmax.
Change in Oral Moisture	Baseline, 3 months, and 6 months	Oral moisture will be assessed using a moisture-checking device placed on the tongue surface. Higher values indicate better salivary condition.