CClinicalTrials.gg
CompletedNCT04984694Updated Jul 30, 2021

Computerized Virtual Reality in Elderly

An interventional study of Computerized virtual reality training programs group (Hot-Plus group) and Social interaction group in Cognitive Dysfunction, Cognitive Change and Independent Living, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-07-30.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 5 months after the study started (first participant enrolled Feb 2017, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

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

Keywords

  • cognitive dysfunction
  • computer-assisted instruction
  • independent living
  • video games
  • quality of life
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 45 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Computerized virtual reality training programs group (Hot-Plus group)

    Participants who are in Hot-Plus group will divide several small groups which will be 4 persons with mild cognitive impairment. Participants will receive computerized virtual reality training program by Hot-Plus as a group activity for one hour, once a week for 12 weeks.

    Behavioral: Computerized virtual reality training programs group (Hot-Plus group)

  • Active comparator
    Social interaction group

    The participants in the social interaction group will come as a group for social interaction one hour weekly for 12 weeks.

    Behavioral: Social interaction group

  • No intervention
    Control group

    The control group will maintain regular activities.

Interventions

  • BehavioralComputerized 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.

  • BehavioralSocial interaction group

    The social interaction group will get together as a group for social interaction one hour weekly for 12 weeks.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: At baseline.

  2. 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).

    Time frame: Immediately after intervention.

  3. 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).

    Time frame: At 4 weeks after intervention.

  4. 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).

    Time frame: At 12 weeks after intervention.

  5. 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).

    Time frame: At 24 weeks after intervention.

  6. 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.

    Time frame: At baseline.

  7. 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.

    Time frame: Immediately after intervention.

  8. 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.

    Time frame: At 4 weeks after intervention.

  9. 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.

    Time frame: At 12 weeks after intervention.

  10. 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.

    Time frame: At 24 weeks after intervention.

  11. Cognition-attention

    Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-Ⅲ (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.

    Time frame: At baseline.

  12. Cognition-attention

    Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-Ⅲ (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.

    Time frame: Immediately after intervention.

  13. Cognition-attention

    Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-Ⅲ (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.

    Time frame: At 4 weeks after intervention.

  14. Cognition-attention

    Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-Ⅲ (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.

    Time frame: At 12 weeks after intervention.

  15. Cognition-attention

    Attention was measured by the Digit Span (DS) subtest from the Taiwan version of the Wechsler Adult Intelligence Scale-Ⅲ (WAIS-IV; Wechsler, 2002), which contained two components: DS forward and DS backward.

    Time frame: At 24 weeks after intervention.

  16. 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).

    Time frame: At baseline.

  17. 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).

    Time frame: Immediately after intervention.

  18. 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).

    Time frame: At 4 weeks after intervention.

  19. 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).

    Time frame: At 12 weeks after intervention.

  20. 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).

    Time frame: At 24 weeks after intervention.

  21. 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).

    Time frame: At baseline.

  22. 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).

    Time frame: Immediately after intervention.

  23. 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).

    Time frame: At 4 weeks after intervention.

  24. 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).

    Time frame: At 12 weeks after intervention.

  25. 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).

    Time frame: At 24 weeks after intervention.

Secondary outcomes

  1. 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).

    Time frame: At baseline.

  2. 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).

    Time frame: Immediately after intervention.

  3. 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).

    Time frame: At 4 weeks after intervention.

  4. 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).

    Time frame: At 12 weeks after intervention.

  5. 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).

    Time frame: At 24 weeks after intervention.

  6. 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).

    Time frame: At baseline.

  7. 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).

    Time frame: Immediately after intervention.

  8. 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).

    Time frame: At 4 weeks after intervention.

  9. 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).

    Time frame: At 12 weeks after intervention.

  10. 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).

    Time frame: At 24 weeks after intervention.

  11. 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) .

    Time frame: At baseline.

  12. 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) .

    Time frame: Immediately after intervention.

  13. 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) .

    Time frame: At 4 weeks after intervention.

  14. 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) .

    Time frame: At 12 weeks after intervention.

  15. 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) .

    Time frame: At 24 weeks after intervention.

  16. 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).

    Time frame: At baseline.

  17. 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).

    Time frame: Immediately after intervention.

  18. 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).

    Time frame: At 4 weeks after intervention.

  19. 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).

    Time frame: At 12 weeks after intervention.

  20. 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).

    Time frame: At 24 weeks after intervention.

  21. 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).

    Time frame: At baseline.

  22. 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).

    Time frame: Immediately after intervention.

  23. 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).

    Time frame: At 4 weeks after intervention.

  24. 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).

    Time frame: At 12 weeks after intervention.

  25. 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).

    Time frame: At 24 weeks after intervention.

  26. 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).

    Time frame: At baseline.

  27. 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).

    Time frame: Immediately after intervention.

  28. 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).

    Time frame: At 4 weeks after intervention.

  29. 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).

    Time frame: At 12 weeks after intervention.

  30. 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).

    Time frame: At 24 weeks after intervention.

  31. 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.

    Time frame: At baseline.

  32. 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.

    Time frame: Immediately after intervention.

  33. 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.

    Time frame: At 4 weeks after intervention.

  34. 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.

    Time frame: At 12 weeks after intervention.

  35. 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.

    Time frame: At 24 weeks after intervention.

  36. 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).

    Time frame: At baseline.

  37. 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).

    Time frame: Immediately after intervention.

  38. 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).

    Time frame: At 4 weeks after intervention.

  39. 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).

    Time frame: At 12 weeks after intervention.

  40. 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).

    Time frame: At 24 weeks after intervention.

07

Study locations

1 site
  • TMU-Shuang-Ho Hospital, Taipei Medical University
    New Taipei City, 23561, Taiwan
08

References and documents

Publications

  • Supreme Investment. Interactive health service system. Supreme Investment website. https://supremeinvest.co/hotplus/. Updated 2016. Accessed March 17, 2017.
  • 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. doi: 10.1016/0022-3956(75)90026-6. No abstract available. PubMed 1202204 ↗
  • 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. doi: 10.1212/wnl.39.9.1159. PubMed 2771064 ↗
  • 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. doi: 10.1212/wnl.44.4.609. PubMed 8164812 ↗
  • 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. doi: 10.1212/wnl.59.6.898. PubMed 12297574 ↗
  • 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.
  • Golden CJ. A group version of the Stroop Color and Word Test. J Pers Assess. 1975 Aug;39(4):386-8. doi: 10.1207/s15327752jpa3904_10. PubMed 16367401 ↗
  • 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. PubMed 32617272 ↗
  • Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available. PubMed 5349366 ↗
  • Rikli RE, Jones CJ. Senior Fitness Test Manual. Champaign: Human Kinetics; 2001.
  • 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.
  • 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.
  • 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. doi: 10.1097/00002093-199809000-00002. PubMed 9772013 ↗
  • 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. doi: 10.1111/j.1532-5415.1975.tb00927.x. PubMed 1159263 ↗
  • 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. PubMed 24183199 ↗
  • 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. PubMed 18194908 ↗
  • EuroQol Research Foundation. EQ-5D-3L User Guidet, 2018. https://euroqol.org/publications/user-guides/. Updated October, 2018. Accessed August 16, 2019.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04984694
Lead sponsor
Taipei Medical University
Collaborators
Ministry of Science and Technology, Taiwan
Responsible party
Sponsor
First posted
Jul 30, 2021
Start date
Feb 3, 2017
Primary completion
Nov 21, 2018
Completion
Mar 6, 2019
Last update
Jul 30, 2021

Study contacts

Chia-Chi Chang, PhD
principal investigator · Taipei Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion