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NCT Number: NCT07191600

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

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.

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Key information

Conditions

Oral Health of Older Men Behavior Personal Satisfaction Psychological Well-Being

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Talking Pen Audio-Interactive Oral Frailty Care Program

Behavioral

Participants in the intervention group will receive a structured oral frailty delay care program integrated with talking pen audio-interactive technology. The program includes bilingual (Mandarin and Taiwanese) teaching materials with audio support to enhance comprehension and engagement. Training sessions will focus on oral frailty prevention, oral function exercises, and related health education. The intervention is delivered over 3 to 6 months, with outcomes measured at baseline, 3 months, and 6 months.

Primary outcomes

  1. Change in Anterior Tongue Pressure

    Time frame: 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.

  2. Change in Posterior Tongue Pressure (Pmax)

    Time frame: 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.

  3. Change in Lip Muscle Pressure (Pmax)

    Time frame: 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.

  4. Change in Orbicularis Oris Pressure (Pmax)

    Time frame: 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.

  5. Change in Oral Moisture

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ya-Wen Kuo Professor, PhD, RN

CONTACT

[email protected]

+886-5-3628800 ext. 2120

Sponsors and collaborators

Lead sponsor

Chang Gung University of Science and Technology

Other

Registry information

Official study title

A Study on the Integration of Talking Pen Audio-Interactive Technology With Oral Frailty Delay Care Programs for Enhancing the Physical and Mental Health of Community-Dwelling Elderly: Development, Testing, and Effectiveness Evaluation in Agricultural Counties

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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