Clinical trial NCT05938166: The Effects of Using Augmented Reality (AR) System to Train Foreign Care Workers.
Official title: The Effects of Using Augmented Reality (AR) System to Train Foreign Care on Salivary Biomarker and Oral Function of the Elderly People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Dryness and Saliva Altered
Oral Manifestations
Swallowing Disorder
Keywords: AR (augmented reality)
Oral Care Behavior
Saliva Biomarker
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to evaluate the effect of augmented reality (AR) system training intervention of foreign care workers on the salivary biomarker and oral function of older people.

This randomized controlled trial included experimental group: AR group (EG-A) Video group (EG-B) and control group(CG), respectively. The EG-A will receive augmented reality (AR) system training intervention with AR tooth-cleaning skills session course add video-based oral hygiene education course . The EG-B receive video-based oral hygiene education course and The CG only receive only a leaflet.

Detailed description: A randomized experimental design was used. Female foreign care workers whose aged 21 to 65 years and by cared older peoples whose aged 65 to 75 years were recruited through community-based site of long-term care service in Kaohsiung city. Each group was expected for 12 care workers and by cared older peoples who each group. G\*Power (version 3.1.9.4) was used for power analysis.

All foreign care workers whose participants will underwent questionnaire examination at baseline and at 1-month, 3-month, 6-month follow-ups. The information of foreign care workers regarding oral care cognition, attitude, self-efficacy, and oral care behavior intention will be collected by a self-report questionnaire before and after intervention.

Each by cared older peoples will be evaluation oral hygiene and function by oral hygienist, and will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up. Older people by cared will assess plaque control record (PCR), tongue coating index (TCI), repetitive saliva swallowing test (RSST), oral diadochokinetic (DDK), oral moisture degree (OMD),masticatory efficiency (MoE) and salivary biomarker at baseline (Time 1), three months (Time 2) and six months (Time 3) follow-ups.

Eligibility criteria: Inclusion Criteria:

* 1. The Indonesian caregivers who are employed in Kaohsiung City are aged between 21 and 65 and have simple Chinese communication skills.
* 2. The elderly people being cared for is over 65 years old.

Exclusion Criteria:

* 1. Elderly people who are unable to cooperate with instructions.
* 2. Elderly people with facial impairment.

Primary outcomes:
measure: Tongue Coating Index(TCI)
timeFrame: Change from Baseline TCI at 1-month after intervention
measure: Tongue Coating Index(TCI)
timeFrame: Change from Baseline TCI at 3-month after intervention
measure: Tongue Coating Index(TCI)
timeFrame: Change from Baseline TCI at 6-month after intervention
measure: Oral Dryness Status
timeFrame: Change from Baseline Oral Dryness Status at 1-month after intervention
measure: Oral Dryness Status
timeFrame: Change from Baseline Oral Dryness Status at 3-month after intervention
measure: Oral Dryness Status
timeFrame: Change from Baseline Oral Dryness Status at 6-month after intervention
measure: Lip-Tongue Motor Function
timeFrame: Change from Baseline lip-tongue motor function Status at 1-month after intervention
measure: Lip-Tongue Motor Function
timeFrame: Change from Baseline lip-tongue motor function Status at 3-month after intervention
measure: Lip-Tongue Motor Function
timeFrame: Change from Baseline lip-tongue motor function Status at 6-month after intervention
measure: Maximum tongue pressure (MTP)
timeFrame: Change from Baseline Maximum tongue pressure status at 1-month after intervention
measure: Maximum tongue pressure (MTP)
timeFrame: Change from Baseline Maximum tongue pressure status at 2-month after intervention
measure: Maximum tongue pressure (MTP)
timeFrame: Change from Baseline Maximum tongue pressure status at 3-month after intervention
measure: Masticatory Function
timeFrame: Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention status at 3-month after intervention
measure: Masticatory Function
timeFrame: Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention status at 3-month after intervention
measure: Masticatory Function
timeFrame: Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention status at 3-month after intervention
measure: Saliva Swallowing Test(RSST)
timeFrame: Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention
measure: Saliva Swallowing Test(RSST)
timeFrame: Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention
measure: Saliva Swallowing Test(RSST)
timeFrame: Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention
Secondary outcomes:
measure: GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
timeFrame: Change from Baseline at 1 month after intervention
measure: GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
timeFrame: Change from Baseline at 3 month after intervention
measure: GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)
timeFrame: Change from Baseline at 6 month after intervention
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
state: Sanmin Dist
Study officials:
References:
citation: Chang AH, Lin PC, Lin PC, Lin YC, Kabasawa Y, Lin CY, Huang HL. Effectiveness of Virtual Reality-Based Training on Oral Healthcare for Disabled Elderly Persons: A Randomized Controlled Trial. J Pers Med. 2022 Feb 4;12(2):218. doi: 10.3390/jpm12020218.