Computerized Virtual Reality in Elderly

Quality of Life Clinical Trial

Official title:

Evaluation of Computerized Virtual Reality on FunctionalAbility and Quality of Life in Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04984694
• Other study ID #: MOST 105-2314-B-038 -063 -MY2
• Status: Completed
• Phase: N/A
• Start date: February 3, 2017
• Est. completion date: March 6, 2019

Study information

• Verified date: November 2016
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The number of dementia patients increased with aging population. People with subjective memory complaints or mild cognitive impairment (MCI) may have a high risk of developing dementia. Cognitive /memory training programs have shown the potential positive effects for improving or maintaining the cognitive progression. However, the impact of those cognitive progressions on functional ability and quality of life is not well understood. In addition, it appears to have large variability responsiveness among trained subjects. Most studies did not examine the individual difference associated with training. The major aim will evaluate the cognitive training programs on functional ability and quality of life in older adults. The results will be expected to understand the effectiveness of the computerized virtual reality training, improving or maintaining cognition, physical and psychosocial function, enhancing quality of life, and reducing the risk of developing disability even conversion into dementia in later life.

Description:

Prevention strategies for dementia are needed because of the increasing prevalence of dementia. People with mild cognitive impairment are at high risk of developing a disability, even conversion into dementia in later life. Cognitive /memory training programs have shown the potential positive effects for improving or maintaining the cognitive progression. However, the impact of those cognitive progressions on functional ability and quality of life is not well understood. The major aim of this total project is to evaluate the short and long-term effects of computerized virtual reality training programs (Xavix Hot-Plus) on functional ability (cognition, physical and psychosocial function) and quality of life in older adults with mild cognitive impairment.

The experimental research design with three groups, one pretest and four posttests will be conducted to examine the short-term and long-term effects on cognition (primary outcome), physical (secondary outcome), psychosocial function (secondary outcome), and quality of life (secondary outcome). Independent adults will be recruited from the community base on sample criteria. The total subjects will be 160 to 190 older adults and the community care centers include all eligible participants will be randomly assigned into computerized virtual reality training programs group (Hot-Plus group) or social interaction group. The subjects for the control group will be recruited in the community and be referred by neurological, psychiatric, or gerontological physicians.

Participants who are in the Hot-Plus group will divide several small groups which will be 4 persons with mild cognitive impairment. Participants will receive a computerized virtual reality training program by Hot-Plus as a group activity one hour, once a week for 12 weeks. The participants in the social interaction group will come as a group for social interaction one hour weekly for 12 weeks. The control group will maintain their regular activities.

Data will be analysed by using SPSS version 18.0 (SPSS, Chicago, IL), with the significance level is set at p< .05. The normal distribution of the data will be evaluated using the Kolmogorov-Smirnov test. Mean, Standard deviation, frequency, and percentage will be performed to describe all variables. One-way analysis of variance (ANOVA) will be used to evaluate differences between groups according to the continuous variables, non-normal distribution of data will be calculated by Kruskasl-Wallis test. The chi-square test will be used for the comparison of categorical variables, and Fisher's exact test will be used due to the expected value less than four. Generalised Estimating Equation (GEE) will be used to examine the main effects, time effects, and interactions in outcomes over time.

The results will be expected to understand the effectiveness of the computerized virtual reality training, improving or maintaining cognition, physical, psychosocial function, enhancing quality of life, and reducing the risk of developing disability even conversion into dementia in later life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 6, 2019
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Equal to or older than 60 years old

• The SPMSQ scores range from 4-7 ( illiterate: 4-5, elementary: 5-6, junior high school: 6-7) or Clinical Dementia Rating Scale (CDR): 0.5

• Be able to communicate in Mandarin or Taiwanese

• Has the ability to see and hear well enough to follow the instructions

• Agree to participate in this study.

Exclusion Criteria:

• Activity restrictions from physician recommendation

• Unstable disease progress could affect their participation

• Surgery for joints or spinal cord within 6 months

• Unable to walk 50 meters with the assistant device

• Learning disability

Related Conditions & MeSH terms

• Cognitive Change
• Cognitive Dysfunction
• Independent Living
• Quality of Life
• Video Games

Intervention

Behavioral:
• Computerized virtual reality training programs group (Hot-Plus group)
In this study, the investigators utilised interactive-video games called "Xavix Hot Plus"(Hot-plus, Shinsedai[SSD] Co. Ltd, Shiga Japan), which was designed specifically for rehabilitation and reported high participant motivation and enjoyment while playing.
• Social interaction group
The social interaction group will get together as a group for social interaction one hour weekly for 12 weeks.

Locations

Country	Name	City	State
Taiwan	TMU-Shuang-Ho Hospital, Taipei Medical University	New Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (17)

Chang TJ, Tarn YH, Hsieh CL, Liou WS, Shaw JW, Chiou XG. Taiwanese version of the EQ-5D: validation in a representative sample of the Taiwanese population. J Formos Med Assoc. 2007 Dec;106(12):1023-31. doi: 10.1016/S0929-6646(08)60078-9. — View Citation

Chang W J, Su MP. Exploring the effects of self-concept and interpersonal relationship who attends the music program for middle-aged and elderly adults in community. Journal of Community Research. 2011:2:109-157.

EuroQol Research Foundation. EQ-5D-3L User Guidet, 2018. https://euroqol.org/publications/user-guides/. Updated October, 2018. Accessed August 16, 2019.

Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. — View Citation

Golden CJ. A group version of the Stroop Color and Word Test. J Pers Assess. 1975 Aug;39(4):386-8. — View Citation

Hawk C, Dusio ME, Wallace H, Bernard T, Rexroth C. Development of a patient-centered instrument for the assessment of global well-being: a study of reliability, validity, and clinical responsiveness. Palmer J Res. 1995;2(1):15-22.

Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. — View Citation

Lee HY, Hung MC, Hu FC, Chang YY, Hsieh CL, Wang JD. Estimating quality weights for EQ-5D (EuroQol-5 dimensions) health states with the time trade-off method in Taiwan. J Formos Med Assoc. 2013 Nov;112(11):699-706. doi: 10.1016/j.jfma.2012.12.015. Epub 2013 Feb 12. — View Citation

Liu HC, Fuh JL, Wang SJ, Liu CY, Larson EB, Lin KN, Wang HC, Chou P, Wu ZA, Lin CH, Wang PN, Teng EL. Prevalence and subtypes of dementia in a rural Chinese population. Alzheimer Dis Assoc Disord. 1998 Sep;12(3):127-34. — View Citation

Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. — View Citation

Pashmdarfard M, Azad A. Assessment tools to evaluate Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) in older adults: A systematic review. Med J Islam Repub Iran. 2020 Apr 13;34:33. doi: 10.34171/mjiri.34.33. eCollection 2020. Review. — View Citation

Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975 Oct;23(10):433-41. — View Citation

Powlishta KK, Von Dras DD, Stanford A, Carr DB, Tsering C, Miller JP, Morris JC. The clock drawing test is a poor screen for very mild dementia. Neurology. 2002 Sep 24;59(6):898-903. — View Citation

Rikli RE, Jones CJ. Senior Fitness Test Manual. Champaign: Human Kinetics; 2001.

Shulman K, Shedletsky R, Silver I. The challenge of time: Clock-drawing and cognitive function in the elderly. Int J Geriat Psychiatry. 1986:1(2):135-140.

Supreme Investment. Interactive health service system. Supreme Investment website. https://supremeinvest.co/hotplus/. Updated 2016. Accessed March 17, 2017.

Welsh KA, Butters N, Mohs RC, Beekly D, Edland S, Fillenbaum G, Heyman A. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part V. A normative study of the neuropsychological battery. Neurology. 1994 Apr;44(4):609-14. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition-Global cognition	Global cognition was measured by the Mini-Mental State Examination (MMSE), a modified version of a neuropsychological battery in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD), which maximum score was 30 including orientation, memory, concentration, language, and praxis (Folstein, Folstein, & McHugh, 1975; Morris et al., 1989).	At baseline.
Primary	Cognition-Global cognition	Global cognition was measured by the Mini-Mental State Examination (MMSE), a modified version of a neuropsychological battery in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD), which maximum score was 30 including orientation, memory, concentration, language, and praxis (Folstein, Folstein, & McHugh, 1975; Morris et al., 1989).	Immediately after intervention.
Primary	Cognition-Global cognition	Global cognition was measured by the Mini-Mental State Examination (MMSE), a modified version of a neuropsychological battery in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD), which maximum score was 30 including orientation, memory, concentration, language, and praxis (Folstein, Folstein, & McHugh, 1975; Morris et al., 1989).	At 4 weeks after intervention.
Primary	Cognition-Global cognition	Global cognition was measured by the Mini-Mental State Examination (MMSE), a modified version of a neuropsychological battery in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD), which maximum score was 30 including orientation, memory, concentration, language, and praxis (Folstein, Folstein, & McHugh, 1975; Morris et al., 1989).	At 12 weeks after intervention.
Primary	Cognition-Global cognition	Global cognition was measured by the Mini-Mental State Examination (MMSE), a modified version of a neuropsychological battery in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD), which maximum score was 30 including orientation, memory, concentration, language, and praxis (Folstein, Folstein, & McHugh, 1975; Morris et al., 1989).	At 24 weeks after intervention.
Primary	Cognition-memory	Memory was measured by the Word List test, contained three types as following (Morris et al., 1989; Welsh et al., 1994): 1) Immediately recall; 2) Delayed recall; 3) Recognition.	At baseline.
Primary	Cognition-memory	Memory was measured by the Word List test, contained three types as following (Morris et al., 1989; Welsh et al., 1994): 1) Immediately recall; 2) Delayed recall; 3) Recognition.	Immediately after intervention.
Primary	Cognition-memory	Memory was measured by the Word List test, contained three types as following (Morris et al., 1989; Welsh et al., 1994): 1) Immediately recall; 2) Delayed recall; 3) Recognition.	At 4 weeks after intervention.
Primary	Cognition-memory	Memory was measured by the Word List test, contained three types as following (Morris et al., 1989; Welsh et al., 1994): 1) Immediately recall; 2) Delayed recall; 3) Recognition.	At 12 weeks after intervention.
Primary	Cognition-memory	Memory was measured by the Word List test, contained three types as following (Morris et al., 1989; Welsh et al., 1994): 1) Immediately recall; 2) Delayed recall; 3) Recognition.	At 24 weeks after intervention.
Primary	Cognition-attention	Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-? (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.	At baseline.
Primary	Cognition-attention	Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-? (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.	Immediately after intervention.
Primary	Cognition-attention	Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-? (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.	At 4 weeks after intervention.
Primary	Cognition-attention	Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-? (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.	At 12 weeks after intervention.
Primary	Cognition-attention	Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-? (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.	At 24 weeks after intervention.
Primary	Cognition-visual/spatial function	Visual/spatial function was measured by the Clock Drawing Test (CDT). Participants were asked to draw a clock face, place all the numbers on it, and set the time to 11 past 10 (Powlishta et al., 2002; Shulman, Shedletsky, & Silver, 1986).	At baseline.
Primary	Cognition-visual/spatial function	Visual/spatial function was measured by the Clock Drawing Test (CDT). Participants were asked to draw a clock face, place all the numbers on it, and set the time to 11 past 10 (Powlishta et al., 2002; Shulman, Shedletsky, & Silver, 1986).	Immediately after intervention.
Primary	Cognition-visual/spatial function	Visual/spatial function was measured by the Clock Drawing Test (CDT). Participants were asked to draw a clock face, place all the numbers on it, and set the time to 11 past 10 (Powlishta et al., 2002; Shulman, Shedletsky, & Silver, 1986).	At 4 weeks after intervention.
Primary	Cognition-visual/spatial function	Visual/spatial function was measured by the Clock Drawing Test (CDT). Participants were asked to draw a clock face, place all the numbers on it, and set the time to 11 past 10 (Powlishta et al., 2002; Shulman, Shedletsky, & Silver, 1986).	At 12 weeks after intervention.
Primary	Cognition-visual/spatial function	Visual/spatial function was measured by the Clock Drawing Test (CDT). Participants were asked to draw a clock face, place all the numbers on it, and set the time to 11 past 10 (Powlishta et al., 2002; Shulman, Shedletsky, & Silver, 1986).	At 24 weeks after intervention.
Primary	Cognition-executive function	Executive function was measured by the Stroop Color and Word Test (SCWT)(Golden et al., 2002). It consisted of three subtasks: word reading (RED, GREEN, and BLUE), color naming (XXXX's colored in red, green, or blue ink), and incongruent color-word naming (the words RED, GREEN, and BLUE printed in not matching red, green, or blue ink).	At baseline.
Primary	Cognition-executive function	Executive function was measured by the Stroop Color and Word Test (SCWT)(Golden et al., 2002). It consisted of three subtasks: word reading (RED, GREEN, and BLUE), color naming (XXXX's colored in red, green, or blue ink), and incongruent color-word naming (the words RED, GREEN, and BLUE printed in not matching red, green, or blue ink).	Immediately after intervention.
Primary	Cognition-executive function	Executive function was measured by the Stroop Color and Word Test (SCWT)(Golden et al., 2002). It consisted of three subtasks: word reading (RED, GREEN, and BLUE), color naming (XXXX's colored in red, green, or blue ink), and incongruent color-word naming (the words RED, GREEN, and BLUE printed in not matching red, green, or blue ink).	At 4 weeks after intervention.
Primary	Cognition-executive function	Executive function was measured by the Stroop Color and Word Test (SCWT)(Golden et al., 2002). It consisted of three subtasks: word reading (RED, GREEN, and BLUE), color naming (XXXX's colored in red, green, or blue ink), and incongruent color-word naming (the words RED, GREEN, and BLUE printed in not matching red, green, or blue ink).	At 12 weeks after intervention.
Primary	Cognition-executive function	Executive function was measured by the Stroop Color and Word Test (SCWT)(Golden et al., 2002). It consisted of three subtasks: word reading (RED, GREEN, and BLUE), color naming (XXXX's colored in red, green, or blue ink), and incongruent color-word naming (the words RED, GREEN, and BLUE printed in not matching red, green, or blue ink).	At 24 weeks after intervention.
Secondary	Physical function-IADL	Instrumental Activities of Daily Living (IADL) were evaluated with eight abilities, including shopping, transportation, meal preparation, ordinary housework, doing laundry, medications, phone use, and managing finances. Individual items are summed to produce a scale that ranges from 0 to 8 (Lawton, & Brody; 1969; Pashmdarfard & Azad, 2020).	At baseline.
Secondary	Physical function-IADL	IADL was evaluated with eight abilities including shopping, transportation, meal preparation, ordinary housework, doing laundry, medications, phone use, and managing finances. Individual items are summed to produce a scale that ranges from 0 to 8 (Lawton, & Brody; 1969; Pashmdarfard & Azad, 2020).	Immediately after intervention.
Secondary	Physical function-IADL	IADL was evaluated with eight abilities including shopping, transportation, meal preparation, ordinary housework, doing laundry, medications, phone use, and managing finances. Individual items are summed to produce a scale that ranges from 0 to 8 (Lawton, & Brody; 1969; Pashmdarfard & Azad, 2020).	At 4 weeks after intervention.
Secondary	Physical function-IADL	IADL was evaluated with eight abilities including shopping, transportation, meal preparation, ordinary housework, doing laundry, medications, phone use, and managing finances. Individual items are summed to produce a scale that ranges from 0 to 8 (Lawton, & Brody; 1969; Pashmdarfard & Azad, 2020).	At 12 weeks after intervention.
Secondary	Physical function-IADL	IADL was evaluated with eight abilities including shopping, transportation, meal preparation, ordinary housework, doing laundry, medications, phone use, and managing finances. Individual items are summed to produce a scale that ranges from 0 to 8 (Lawton, & Brody; 1969; Pashmdarfard & Azad, 2020).	At 24 weeks after intervention.
Secondary	Physical function-senior fitness test (SFT)	A series of functional test include chair stand test, 8-ft up and go test, chair sit and reach test, 6-min walk test, and unipedal stance test was developed by Rikli & Jones.; It has good reliability and validity and test-retest reliability is above 0.9 (Rikli & Jones, 2001).	At baseline.
Secondary	Physical function-senior fitness test (SFT)	A series of functional test include chair stand test, 8-ft up and go test, chair sit and reach test, 6-min walk test, and unipedal stance test was developed by Rikli & Jones.; It has good reliability and validity and test-retest reliability is above 0.9 (Rikli & Jones, 2001).	Immediately after intervention.
Secondary	Physical function-senior fitness test (SFT)	A series of functional test include chair stand test, 8-ft up and go test, chair sit and reach test, 6-min walk test, and unipedal stance test was developed by Rikli & Jones.; It has good reliability and validity and test-retest reliability is above 0.9 (Rikli & Jones, 2001).	At 4 weeks after intervention.
Secondary	Physical function-senior fitness test (SFT)	A series of functional test include chair stand test, 8-ft up and go test, chair sit and reach test, 6-min walk test, and unipedal stance test was developed by Rikli & Jones.; It has good reliability and validity and test-retest reliability is above 0.9 (Rikli & Jones, 2001).	At 12 weeks after intervention.
Secondary	Physical function-senior fitness test (SFT)	A series of functional test include chair stand test, 8-ft up and go test, chair sit and reach test, 6-min walk test, and unipedal stance test was developed by Rikli & Jones.; It has good reliability and validity and test-retest reliability is above 0.9 (Rikli & Jones, 2001).	At 24 weeks after intervention.
Secondary	Physical function-unipedal stance test (UST)	Unipedal stance test was used to examine the static balance on the preferred leg. Participants performed three trials with the eyes open during the test (Goldberg, Casby, & Wasielewski, 2011) .	At baseline.
Secondary	Physical function-unipedal stance test (UST)	Unipedal stance test was used to examine the static balance on the preferred leg. Participants performed three trials with the eyes open during the test (Goldberg, Casby, & Wasielewski, 2011) .	Immediately after intervention.
Secondary	Physical function-unipedal stance test (UST)	Unipedal stance test was used to examine the static balance on the preferred leg. Participants performed three trials with the eyes open during the test (Goldberg, Casby, & Wasielewski, 2011) .	At 4 weeks after intervention.
Secondary	Physical function-unipedal stance test (UST)	Unipedal stance test was used to examine the static balance on the preferred leg. Participants performed three trials with the eyes open during the test (Goldberg, Casby, & Wasielewski, 2011) .	At 12 weeks after intervention.
Secondary	Physical function-unipedal stance test (UST)	Unipedal stance test was used to examine the static balance on the preferred leg. Participants performed three trials with the eyes open during the test (Goldberg, Casby, & Wasielewski, 2011) .	At 24 weeks after intervention.
Secondary	Psychosocial factors-Global Well-Being Scale (GWBS)	Global Well-Being Scale (GWBS): It is a 10-centimeter visual analog scale to measures individuals' perception of well-being. The score of GWBS ranged from 0 to 10 (Hawk et al., 2010).; Analog Scale (VAS) with a ten-centimeter horizontal line (Hawk et al., 2010).	At baseline.
Secondary	Psychosocial factors-Global Well-Being Scale (GWBS)	Global Well-Being Scale (GWBS): It is a 10-centimeter visual analog scale to measures individuals' perception of well-being. The score of GWBS ranged from 0 to 10 (Hawk et al., 2010).; Analog Scale (VAS) with a ten-centimeter horizontal line (Hawk et al., 2010).	Immediately after intervention.
Secondary	Psychosocial factors-Global Well-Being Scale (GWBS)	Global Well-Being Scale (GWBS): It is a 10-centimeter visual analog scale to measures individuals' perception of well-being. The score of GWBS ranged from 0 to 10 (Hawk et al., 2010).; Analog Scale (VAS) with a ten-centimeter horizontal line (Hawk et al., 2010).	At 4 weeks after intervention.
Secondary	Psychosocial factors-Global Well-Being Scale (GWBS)	Global Well-Being Scale (GWBS): It is a 10-centimeter visual analog scale to measures individuals' perception of well-being. The score of GWBS ranged from 0 to 10 (Hawk et al., 2010).; Analog Scale (VAS) with a ten-centimeter horizontal line (Hawk et al., 2010).	At 12 weeks after intervention.
Secondary	Psychosocial factors-Global Well-Being Scale (GWBS)	Global Well-Being Scale (GWBS): It is a 10-centimeter visual analog scale to measures individuals' perception of well-being. The score of GWBS ranged from 0 to 10 (Hawk et al., 2010).; Analog Scale (VAS) with a ten-centimeter horizontal line (Hawk et al., 2010).	At 24 weeks after intervention.
Secondary	Psychosocial factors-Interpersonal Relationship Scale (IRS)	This scale was developed by Chang and Su (2011) in order to know the interpersonal relationship for middle-aged and older Adults.; It's composed of 22 questions related to the interpersonal relationship: close interaction, approach to others, and friendship support (Chang & Su, 2011).	At baseline.
Secondary	Psychosocial factors-Interpersonal Relationship Scale (IRS)	This scale was developed by Chang and Su (2011) in order to know the interpersonal relationship for middle-aged and older Adults.; It's composed of 22 questions related to the interpersonal relationship: close interaction, approach to others, and friendship support (Chang & Su, 2011).	Immediately after intervention.
Secondary	Psychosocial factors-Interpersonal Relationship Scale (IRS)	This scale was developed by Chang and Su (2011) in order to know the interpersonal relationship for middle-aged and older Adults.; It's composed of 22 questions related to the interpersonal relationship: close interaction, approach to others, and friendship support (Chang & Su, 2011).	At 4 weeks after intervention.
Secondary	Psychosocial factors-Interpersonal Relationship Scale (IRS)	This scale was developed by Chang and Su (2011) in order to know the interpersonal relationship for middle-aged and older Adults.; It's composed of 22 questions related to the interpersonal relationship: close interaction, approach to others, and friendship support (Chang & Su, 2011).	At 12 weeks after intervention.
Secondary	Psychosocial factors-Interpersonal Relationship Scale (IRS)	This scale was developed by Chang and Su (2011) in order to know the interpersonal relationship for middle-aged and older Adults.; It's composed of 22 questions related to the interpersonal relationship: close interaction, approach to others, and friendship support (Chang & Su, 2011).	At 24 weeks after intervention.
Secondary	Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)	Chinese version of the GDS-S consisted 15 items with yes/no questions and higher scores indicate a more severe level of depression (Lu, Liu, & Yu, 1998; Pfeiffer, 1975).	At baseline.
Secondary	Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)	Chinese version of the GDS-S consisted 15 items with yes/no questions and higher scores indicate a more severe level of depression (Lu, Liu, & Yu, 1998; Pfeiffer, 1975).	Immediately after intervention.
Secondary	Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)	Chinese version of the GDS-S consisted 15 items with yes/no questions and higher scores indicate a more severe level of depression (Lu, Liu, & Yu, 1998; Pfeiffer, 1975).	At 4 weeks after intervention.
Secondary	Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)	Chinese version of the GDS-S consisted 15 items with yes/no questions and higher scores indicate a more severe level of depression (Lu, Liu, & Yu, 1998; Pfeiffer, 1975).	At 12 weeks after intervention.
Secondary	Psychosocial factors-Geriatric Depression Scale-Short Form (GDS-SF)	Chinese version of the GDS-S consisted 15 items with yes/no questions and higher scores indicate a more severe level of depression (Lu, Liu, & Yu, 1998; Pfeiffer, 1975).	At 24 weeks after intervention.
Secondary	Quality of Life-EQ5D-Utility	EQ-5D-3L Taiwanese version questionnaire was selected to measure health-related quality of life (HRQOL) which was recommended in older adults and people with mild dementia (Aguirre, Kang, Hoare, Edwards, & Orrell, 2016; León-Salas et al., 2015). According to the self-report index scores, it can be converted to a single summary utility score by using the time trade-off (TTO) technique. The range of this EQ-5D-3L utility score (EQ5D-Utility) was -0.67 to 1.00 by using the Taiwanese value set (Lee et al., 2013), as the score closer to 1 indicated the better health, a negative score indicated worse than dead, and a 0.5 score could be acceptable.	At baseline.
Secondary	Quality of Life-EQ5D-Utility	EQ-5D-3L Taiwanese version questionnaire was selected to measure health-related quality of life (HRQOL) which was recommended in older adults and people with mild dementia (Aguirre, Kang, Hoare, Edwards, & Orrell, 2016; León-Salas et al., 2015). According to the self-report index scores, it can be converted to a single summary utility score by using the time trade-off (TTO) technique. The range of this EQ-5D-3L utility score (EQ5D-Utility) was -0.67 to 1.00 by using the Taiwanese value set (Lee et al., 2013), as the score closer to 1 indicated the better health, a negative score indicated worse than dead, and a 0.5 score could be acceptable.	Immediately after intervention.
Secondary	Quality of Life-EQ5D-Utility	EQ-5D-3L Taiwanese version questionnaire was selected to measure health-related quality of life (HRQOL) which was recommended in older adults and people with mild dementia (Aguirre, Kang, Hoare, Edwards, & Orrell, 2016; León-Salas et al., 2015). According to the self-report index scores, it can be converted to a single summary utility score by using the time trade-off (TTO) technique. The range of this EQ-5D-3L utility score (EQ5D-Utility) was -0.67 to 1.00 by using the Taiwanese value set (Lee et al., 2013), as the score closer to 1 indicated the better health, a negative score indicated worse than dead, and a 0.5 score could be acceptable.	At 4 weeks after intervention.
Secondary	Quality of Life-EQ5D-Utility	EQ-5D-3L Taiwanese version questionnaire was selected to measure health-related quality of life (HRQOL) which was recommended in older adults and people with mild dementia (Aguirre, Kang, Hoare, Edwards, & Orrell, 2016; León-Salas et al., 2015). According to the self-report index scores, it can be converted to a single summary utility score by using the time trade-off (TTO) technique. The range of this EQ-5D-3L utility score (EQ5D-Utility) was -0.67 to 1.00 by using the Taiwanese value set (Lee et al., 2013), as the score closer to 1 indicated the better health, a negative score indicated worse than dead, and a 0.5 score could be acceptable.	At 12 weeks after intervention.
Secondary	Quality of Life-EQ5D-Utility	EQ-5D-3L Taiwanese version questionnaire was selected to measure health-related quality of life (HRQOL) which was recommended in older adults and people with mild dementia (Aguirre, Kang, Hoare, Edwards, & Orrell, 2016; León-Salas et al., 2015). According to the self-report index scores, it can be converted to a single summary utility score by using the time trade-off (TTO) technique. The range of this EQ-5D-3L utility score (EQ5D-Utility) was -0.67 to 1.00 by using the Taiwanese value set (Lee et al., 2013), as the score closer to 1 indicated the better health, a negative score indicated worse than dead, and a 0.5 score could be acceptable.	At 24 weeks after intervention.
Secondary	Quality of Life-EQ5D-visual analogue scale	A 20-cm visual analogue scale in which respondents are asked to rate their current health status ranging from 0 (Worst imaginable health state) to 100 (Chang et al., 2007; EuroQol Research Foundation, 2018).	At baseline.
Secondary	Quality of Life-EQ5D-visual analogue scale	A 20-cm visual analogue scale in which respondents are asked to rate their current health status ranging from 0 (Worst imaginable health state) to 100 (Chang et al., 2007; EuroQol Research Foundation, 2018).	Immediately after intervention.
Secondary	Quality of Life-EQ5D-visual analogue scale	A 20-cm visual analogue scale in which respondents are asked to rate their current health status ranging from 0 (Worst imaginable health state) to 100 (Chang et al., 2007; EuroQol Research Foundation, 2018).	At 4 weeks after intervention.
Secondary	Quality of Life-EQ5D-visual analogue scale	A 20-cm visual analogue scale in which respondents are asked to rate their current health status ranging from 0 (Worst imaginable health state) to 100 (Chang et al., 2007; EuroQol Research Foundation, 2018).	At 12 weeks after intervention.
Secondary	Quality of Life-EQ5D-visual analogue scale	A 20-cm visual analogue scale in which respondents are asked to rate their current health status ranging from 0 (Worst imaginable health state) to 100 (Chang et al., 2007; EuroQol Research Foundation, 2018).	At 24 weeks after intervention.