Oral Health of Older MenNCT07191600
Talking Pen Audio-Interactive Program for Oral Frailty Delay in Community-Dwelling Elderly
A study testing Talking Pen Audio-Interactive Oral Frailty Care Program in people with Oral Health of Older Men, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health of Older Men
- What is being tested?
- Talking Pen Audio-Interactive Oral Frailty Care Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung University of Science and Technology, Chiayi Campus
Chiayi City, Chiayi, 613
About this study
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
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.
- Conditions
- Oral Health of Older Men
- Being tested
- Talking Pen Audio-Interactive Oral Frailty Care Program
- Keywords
- Interactive Technology, Community-Dwelling Older Adults, Oral Frailty, Physical Health, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talking Pen Audio-Interactive Oral Frailty Care ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will receive an oral frailty delay care program integrated with talking pen audio-interactive technology. The program includes bilingual (Mandarin and Taiwanese) teaching materials and structured oral frailty care activities, supported by audio-interactive tools. The intervention is conducted over 3-6 months, with follow-up assessments at baseline, 3 months, and 6 months. Receives: Behavioral: Talking Pen Audio-Interactive Oral Frailty Care Program |
| Arm 2 | No intervention | Participants will continue their usual community activities without exposure to the talking pen audio-interactive oral frailty care program. Assessments will be conducted at baseline, 3 months, and 6 months for comparison with the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anterior Tongue Pressure
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.
Measured: Baseline, 3 months, and 6 months
Change in Posterior Tongue Pressure (Pmax)
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.
Measured: Baseline, 3 months, and 6 months.
Change in Lip Muscle Pressure (Pmax)
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.
Measured: Baseline, 3 months, and 6 months.
Change in Orbicularis Oris Pressure (Pmax)
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.
Measured: Baseline, 3 months, and 6 months.
Change in Oral Moisture
Oral moisture will be assessed using a moisture-checking device placed on the tongue surface. Higher values indicate better salivary condition.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Jan 2026
- Primary completion30 Sep 2026
- Study completion20 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health of Older MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191600
- Sponsor's protocol ID
- 113-813
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07191600
- Acronym / sponsor ID
- 113-813
- Conditions
- Oral Health of Older Men
- Keywords
- Interactive Technology, Community-Dwelling Older Adults, Oral Frailty, Physical Health, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 20 Oct 2026 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Talking Pen Audio-Interactive Oral Frailty Care ProgramParticipants will receive an oral frailty delay care program integrated with talking pen audio-interactive technology. The program includes bilingual (Mandarin and Taiwanese) teaching materials and structured oral frailty care activities, supported by audio-interactive tools. The intervention is conducted over 3-6 months, with follow-up assessments at baseline, 3 months, and 6 months. |
| Arm 2 | No intervention | –Participants will continue their usual community activities without exposure to the talking pen audio-interactive oral frailty care program. Assessments will be conducted at baseline, 3 months, and 6 months for comparison with the intervention group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talking Pen Audio-Interactive Oral Frailty Care ProgramParticipants 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. | Behavioural | Arm 1 |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talking Pen Audio-Interactive Oral Frailty Care Program in people with Oral Health of Older Men, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anterior Tongue Pressure (time frame: Baseline, 3 months, and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.