The Effects of Using Augmented Reality (AR) Simulation System to Train Foreign Care Workers.

Swallowing Disorder Clinical Trial

Official title:

The Effects of Using Augmented Reality (AR) Simulation System to Train Foreign Care Workers on Function of the Older People.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938166
• Other study ID #: KMUHIRB-SV(II)-20230019
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: leu k hsun, Master
• Phone: +886-7-3121101
• Email: leu1026[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the effect of augmented reality (AR) simulation training intervention of foreign care workers on the oral function of older people.

This randomized controlled trial included experimental group: AR group (EG) and control group(CG), respectively. The EG will receive augmented reality (AR) simulation training intervention with traditional classroom oral health education. The CG only receive traditional classroom oral health education.

Description:

A randomized experimental design was used. foreign care workers whose aged 21 to 65 years and by cared older peoples whose aged 65 to 75 years were recruited through community C site in Kaohsiung city. Each group was expected for 80 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), and masticatory efficiency (MoE) at baseline (Time 1), three months (Time 2) and six months (Time 3) follow-ups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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 under their care are between 65 and 75 years old.

• 3. The ADL(activity of daily living) evaluation score of the elderly under their care >= 61.

Exclusion Criteria:

• 1. Older people with no teeth.

• 2. Older people with moderate to severe mental impairment.

• 3. Older people with damaged face.

• 4. Older people with NG(nasogastric) .

Related Conditions & MeSH terms

• Deglutition Disorders
• Oral Manifestations
• Swallowing Disorder

Intervention

Device:
• oral care augmented reality (AR)
Augmented reality (AR) is an extension of perceptible reality, whereby additional information, such as texts or virtual objects, can be displayed in the user's field of vision.The oral care augmented reality (AR) simulation training can train foreign care workers by switching languages (Indonesian) and therefore reduce language-related learning barriers.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University	Kaohsiung	Sanmin Dist

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tongue Coating Index(TCI)	The tongue-coating status of 9 areas of tongue surfaces was recorded using the tongue coating index, as follows: Score 0: Tongue coating not visible.; Score 1: Tongue coating thin, papillae of tongue visible.; Score 2: Tongue coating very thick, papillae of tongue not visible.; Range= 0 to 18 Score	Change from Baseline TCI at 1-month after intervention
Primary	Tongue Coating Index(TCI)	The tongue-coating status of 9 areas of tongue surfaces was recorded using the tongue coating index, as follows: Score 0: Tongue coating not visible.; Score 1: Tongue coating thin, papillae of tongue visible.; Score 2: Tongue coating very thick, papillae of tongue not visible.; Range= 0 to 18 Score	Change from Baseline TCI at 3-month after intervention
Primary	Tongue Coating Index(TCI)	The tongue-coating status of 9 areas of tongue surfaces was recorded using the tongue coating index, as follows: Score 0: Tongue coating not visible.; Score 1: Tongue coating thin, papillae of tongue visible.; Score 2: Tongue coating very thick, papillae of tongue not visible.; Range= 0 to 18 Score	Change from Baseline TCI at 6-month after intervention
Primary	Oral Dryness Status	The oral dryness status of saliva flow rate was recorded using the saxon test(Chew gauze sponge for 2 mins), as follows: Normal: 2.75 g/2min.; Oral dryness: 2 g/2min.	Change from Baseline Oral Dryness Status at 1-month after intervention
Primary	Oral Dryness Status	The oral dryness status of saliva flow rate was recorded using the saxon test(Chew gauze sponge for 2 mins), as follows: Normal: 2.75 g/2min.; Oral dryness: 2 g/2min.	Change from Baseline Oral Dryness Status at 3-month after intervention
Primary	Oral Dryness Status	The oral dryness status of saliva flow rate was recorded using the saxon test(Chew gauze sponge for 2 mins), as follows: Normal: 2.75 g/2min.; Oral dryness: 2 g/2min.	Change from Baseline Oral Dryness Status at 6-month after intervention
Primary	Lip-Tongue Motor Function	The lip-tongue motor function status of count-by-time was recorded using the Oral diadochokinesis rate (lip-tongue function (Pa/ Ta /Ka) in syllables or times per 15 seconds), as follows: Pa:times/ per 15 seconds; Ta:times /per 15 seconds; Ka:times /per 15 seconds	Change from Baseline lip-tongue motor function Status at 1-month after intervention
Primary	Lip-Tongue Motor Function	The lip-tongue motor function status of count-by-time was recorded using the Oral diadochokinesis rate (lip-tongue function (Pa/ Ta /Ka) in syllables or times per 15 seconds), as follows: Pa:times/ per 15 seconds; Ta:times /per 15 seconds; Ka:times /per 15 seconds	Change from Baseline lip-tongue motor function Status at 3-month after intervention
Primary	Lip-Tongue Motor Function	The lip-tongue motor function status of count-by-time was recorded using the Oral diadochokinesis rate (lip-tongue function (Pa/ Ta /Ka) in syllables or times per 15 seconds), as follows: Pa:times/ per 15 seconds; Ta:times /per 15 seconds; Ka:times /per 15 seconds	Change from Baseline lip-tongue motor function Status at 6-month after intervention
Primary	Maximum tongue pressure (MTP)	The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: First times / Maximum Kpa value.; Second times / Maximum Kpa value.; Third times / Maximum Kpa value.; Average of maximum tongue pressure in 3 times.	Change from Baseline Maximum tongue pressure status at 1-month after intervention
Primary	Maximum tongue pressure (MTP)	The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: First times / Maximum Kpa value.; Second times / Maximum Kpa value.; Third times / Maximum Kpa value.; Average of maximum tongue pressure in 3 times.	Change from Baseline Maximum tongue pressure status at 2-month after intervention
Primary	Maximum tongue pressure (MTP)	The tongue pressure of 3 times pressure average was recorded using the Maximum tongue pressure test, as follows: First times / Maximum Kpa value.; Second times / Maximum Kpa value.; Third times / Maximum Kpa value.; Average of maximum tongue pressure in 3 times.	Change from Baseline Maximum tongue pressure status at 3-month after intervention
Primary	Masticatory Function	The mixing ability was assessed using color-changeable chewing gum (Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan) , as follows: To chew as usual on the gum 120 seconds. The chewing rhythm was kept constant at once per second.color scale consisting of five intermediate colors .; light green: very poor chewing ability.; light yellow: poor chewing ability.; light pink: no good chewing ability.; pink: good chewing ability.; red: very good chewing ability.	Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention status at 3-month after intervention
Primary	Masticatory Function	The mixing ability was assessed using color-changeable chewing gum (Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan) , as follows: To chew as usual on the gum 120 seconds. The chewing rhythm was kept constant at once per second.color scale consisting of five intermediate colors .; light green: very poor chewing ability.; light yellow: poor chewing ability.; light pink: no good chewing ability.; pink: good chewing ability.; red: very good chewing ability.	Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention status at 3-month after intervention
Primary	Masticatory Function	The mixing ability was assessed using color-changeable chewing gum (Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan) , as follows: To chew as usual on the gum 120 seconds. The chewing rhythm was kept constant at once per second.color scale consisting of five intermediate colors .; light green: very poor chewing ability.; light yellow: poor chewing ability.; light pink: no good chewing ability.; pink: good chewing ability.; red: very good chewing ability.	Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention status at 3-month after intervention
Primary	Saliva Swallowing Test(RSST)	The swallowing function states of times complete swallowing within 30 seconds was recorded using the Saliva Swallowing Test(RSST), as follows: participation was asked to swallow saliva as many times as possible for 30 s, while deglutition is counted through palpation of the larynx.	Change from Baseline Change from Baseline Maximum tongue pressure status at 1-month after intervention
Primary	Saliva Swallowing Test(RSST)	The swallowing function states of times complete swallowing within 30 seconds was recorded using the Saliva Swallowing Test(RSST), as follows: participation was asked to swallow saliva as many times as possible for 30 s, while deglutition is counted through palpation of the larynx.	Change from Baseline Change from Baseline Maximum tongue pressure status at 3-month after intervention
Primary	Saliva Swallowing Test(RSST)	The swallowing function states of times complete swallowing within 30 seconds was recorded using the Saliva Swallowing Test(RSST), as follows: participation was asked to swallow saliva as many times as possible for 30 s, while deglutition is counted through palpation of the larynx.	Change from Baseline Change from Baseline Maximum tongue pressure status at 6-month after intervention
Secondary	GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)	The GOHAI-T of 12 questions was assessment using self-assessment oral health questionnaire.; Have participants been totally unable to function" The scores ranged from one ("never") to five ("always"), with the total possible score ranging from 12 to 60.	Change from Baseline at 1 month after intervention
Secondary	GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)	The GOHAI-Scale of 12 questions was assessment using self-assessment oral health questionnaire.; Have participants been totally unable to function" The scores ranged from one ("never") to five ("always"), with the total possible score ranging from 12 to 60.	Change from Baseline at 3 month after intervention
Secondary	GOHAI-T(Geriatric Oral Health Assessment Index-Taiwan)	The GOHAI-Scale of 12 questions was assessment using self-assessment oral health questionnaire.; Have participants been totally unable to function" The scores ranged from one ("never") to five ("always"), with the total possible score ranging from 12 to 60.	Change from Baseline at 6 month after intervention