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Not yet recruiting NCT07191600

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

No phase Interventional Oral Health of Older Men

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Talking Pen Audio-Interactive Oral Frailty Care Program.
Who it may be relevant to
Registry conditions: Oral Health of Older Men. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Behavioral Talking Pen Audio-Interactive Oral Frailty Care Program
    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, an

Primary outcome measures

  • Change in Anterior Tongue Pressure [Time frame: Baseline, 3 months, and 6 months]
  • Change in Posterior Tongue Pressure (Pmax) [Time frame: Baseline, 3 months, and 6 months.]
  • Change in Lip Muscle Pressure (Pmax) [Time frame: Baseline, 3 months, and 6 months.]
  • Change in Orbicularis Oris Pressure (Pmax) [Time frame: Baseline, 3 months, and 6 months.]
  • Change in Oral Moisture [Time frame: Baseline, 3 months, and 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07191600 · 113-813

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗