Back to resultsThe Effects of a Tele-health Program
Primary Purpose
Frailty, Old Age; Debility
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Individualized motion-based interactive game program
Sponsored by
About this trial
This is an interventional prevention trial for Frailty focused on measuring technology device, occupational therapy, young adult, frail older adults, self-care
Eligibility Criteria
For older adults:
Inclusion Criteria:
- aged 60 or above
- having level of frailty from "managing well" to "living with severe frailty" (Clinical Frailty Scale score 3-7) -- HK-MoCA score 23 or less (add one point to people who had less than 6 year formal education and add 2 points to people who had no formal education)
Exclusion Criteria:
- currently receiving any kind of rehabilitation service
- living with another older adult who is participating in the same study.
For young adults:
Inclusion Criteria:
- aged 17 to 35
- having educational level of secondary 5 or above
Exclusion Criteria:
- having a full-time job
Sites / Locations
- Community centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Individualized motion-based interactive game program
The control group participants will receive usual care, that is, service that provided by community elderly center
Outcomes
Primary Outcome Measures
The change of physical activity before and after the program
Physical activities of the older adults will be measured by the Chinese version of the Physical Activity Scale for the Elderly. The PASE-C is a 12-items scale estimating the frequency and intensity of older adults' lifestyle physical activities with three types of physical activities (leisure-time activity: 5 items; household activity: 6 items; work-related activity: 1 item) during the previous 7-day period. The total score is computed by the multiplication on the time spent (recorded as never, seldom: 1-2 days per week, sometimes: 3-4 days per week, and often: 5-7 days per week) or participation (yes/no) on each activity by items weights, and summarize all the items. Higher scores mean higher frequency and intensity of physical activities.
Secondary Outcome Measures
The change of balance before and after the program
Balance will be assessed using the Berg functional balance scale. It is a 14-item scale designed to measure balance of the older adult in a community setting. The scores of the scale range from 0 to 56, with higher the score, better the balance
The change of cognition status before and after the program
Cognition status will be measured by the Chinese version of the Mini-Mental State Examination. The Mini mental state examination contains questions in seven domains, such as temporal and spatial orientation, word encoding, attention and calculation, word recall, language, and visual constructive capacity. The scores of scale range from 0 to 30, with higher scores indicate better cognitive status
The change of short-term memory before and after the program
Short-term memory will be assessed using the digit span forward test. It consists of the presentation of a list of numbers, which should be correctly repeated in a forward order immediately after their presentation. Higher scores mean better short-term memory.
The change of loneliness level before and after the program
Loneliness will be assessed using the UCLA Loneliness Scale. Each participant will be asked the following three questions: "How often do you feel that you lack companionship?", "How often do you feel left out?" and "How often do you feel isolated from others?". Each question had three options to reflect the frequency:1 = Hardly ever, 2 = Some of the time, and 3 = Often). The values for each question will be summed to get a loneliness score ranging from 3 to 9, with higher values indicating greater loneliness.
The change of social isolation before and after the program
Social isolation will be measured by the two subscales of the 6-item Lubben Social Network Scale-6. Each subscale score ranges from 0 to 15, with lower score indicating greater isolation.
The change of quality of life before and after the program
Quality of life will be measured by SF-12v2, which has been translated, validated and proven reliable for use among the Hong Kong Chinese population. Score 50 is a norm globally. Higher score means better quality of life.
The change of depression level before and after the program
Depression will be measured by the Chinese version of the Geriatric Depression Scale. The scale ranges from 0-12, with higher score indicates higher depression level.
The change of self-efficacy before and after the program
Self-efficacy will be assessed using the Chinese version of the General Self-Efficacy Scale. It is a ten-item scale measuring a broad and stable sense of personal competence to deal efficiently with a variety of stressful situations. The C-GSE measures the strength dimension of self-efficacy on a four-point Likert scale. Scores are summed to give a total range from 10 to 40; higher scores represent greater self-efficacy.
The change of social connectedness before and after the program
Social connectedness will be assessed using the Social Connectedness Scale-Revised. The SCS-R, like its predecessor, measures social connectedness as a psychological sense of belonging or, more specifically, as a cognition of enduring interpersonal closeness with the social world in toto. The scale consists of 20 items (10 positive and 10 negative) rated on a 6-point Likert scale with higher scores represent better social connectedness
The change of attitude towards elderly before and after the program
Attitude towards elderly will be assessed using Kogan's (1961) Attitude toward Old People scale. The Attitude toward old people scale consists of 34 items grouped into two factors that assess positive and negative attitudes toward old people. Kogan's attitude toward old people consisted of 3 domains: personal appearance, resemblance, and the nature of interpersonal relations across age generations. The scores of the scale range from 34 to 204, with higher scores mean better attitude towards elderly
The change of life satisfaction before and after the program
Life satisfaction will be assessed using the satisfaction with life scale (SWLS).It is a 5-item scale designed to measure global cognitive judgments of one's life satisfaction (not a measure of either positive or negative affect). Participants will indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. Higher scores indicate better life satisfaction
The change of community involvement before and after the completion of the program
Community involvement will be assessed by asking the participants their number of hours involved in elderly services six months after the completion of the program. Higher hours represent better community involvement
Recruitment rate after the completion of the program
Recruitment rate will be obtained by asking the participant their working status at 6 months after the completion of the program. More people recruited to elderly service work, better the recruitment rate
Full Information
NCT ID
NCT05267444
First Posted
February 24, 2022
Last Updated
September 20, 2023
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT05267444
Brief Title
The Effects of a Tele-health Program
Official Title
The Effects of a Tele-health Program to Facilitate the Usage of Internet of Things Among Community-dwelling Frail Older Adults: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 11, 2023 (Anticipated)
Study Completion Date
November 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Frailty is a state of being vulnerable and functional disable due to age-related decline of multiple physiological systems, and is often associated with higher risk of falls, institutionalization, hospitalization, disability, dementia, and death. One of the best strategies to combat the burden of frailty is to promote physical activity in the aging population, especially to the older adults who are already in a frail condition
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Old Age; Debility
Keywords
technology device, occupational therapy, young adult, frail older adults, self-care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Individualized motion-based interactive game program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group participants will receive usual care, that is, service that provided by community elderly center
Intervention Type
Procedure
Intervention Name(s)
Individualized motion-based interactive game program
Intervention Description
The participants will receive a 12-session, 4.5 months home visit service that is provided by the young adults, and supervised by an occupational therapist. Young adults will follow the individualized exercise plan with the older adults, facilitate their use of interactive games, provide psychological and technological support to help older adults cope with their fear of using technologies to perform physical activity.
Primary Outcome Measure Information:
Title
The change of physical activity before and after the program
Description
Physical activities of the older adults will be measured by the Chinese version of the Physical Activity Scale for the Elderly. The PASE-C is a 12-items scale estimating the frequency and intensity of older adults' lifestyle physical activities with three types of physical activities (leisure-time activity: 5 items; household activity: 6 items; work-related activity: 1 item) during the previous 7-day period. The total score is computed by the multiplication on the time spent (recorded as never, seldom: 1-2 days per week, sometimes: 3-4 days per week, and often: 5-7 days per week) or participation (yes/no) on each activity by items weights, and summarize all the items. Higher scores mean higher frequency and intensity of physical activities.
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Secondary Outcome Measure Information:
Title
The change of balance before and after the program
Description
Balance will be assessed using the Berg functional balance scale. It is a 14-item scale designed to measure balance of the older adult in a community setting. The scores of the scale range from 0 to 56, with higher the score, better the balance
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of cognition status before and after the program
Description
Cognition status will be measured by the Chinese version of the Mini-Mental State Examination. The Mini mental state examination contains questions in seven domains, such as temporal and spatial orientation, word encoding, attention and calculation, word recall, language, and visual constructive capacity. The scores of scale range from 0 to 30, with higher scores indicate better cognitive status
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of short-term memory before and after the program
Description
Short-term memory will be assessed using the digit span forward test. It consists of the presentation of a list of numbers, which should be correctly repeated in a forward order immediately after their presentation. Higher scores mean better short-term memory.
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of loneliness level before and after the program
Description
Loneliness will be assessed using the UCLA Loneliness Scale. Each participant will be asked the following three questions: "How often do you feel that you lack companionship?", "How often do you feel left out?" and "How often do you feel isolated from others?". Each question had three options to reflect the frequency:1 = Hardly ever, 2 = Some of the time, and 3 = Often). The values for each question will be summed to get a loneliness score ranging from 3 to 9, with higher values indicating greater loneliness.
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of social isolation before and after the program
Description
Social isolation will be measured by the two subscales of the 6-item Lubben Social Network Scale-6. Each subscale score ranges from 0 to 15, with lower score indicating greater isolation.
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of quality of life before and after the program
Description
Quality of life will be measured by SF-12v2, which has been translated, validated and proven reliable for use among the Hong Kong Chinese population. Score 50 is a norm globally. Higher score means better quality of life.
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of depression level before and after the program
Description
Depression will be measured by the Chinese version of the Geriatric Depression Scale. The scale ranges from 0-12, with higher score indicates higher depression level.
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of self-efficacy before and after the program
Description
Self-efficacy will be assessed using the Chinese version of the General Self-Efficacy Scale. It is a ten-item scale measuring a broad and stable sense of personal competence to deal efficiently with a variety of stressful situations. The C-GSE measures the strength dimension of self-efficacy on a four-point Likert scale. Scores are summed to give a total range from 10 to 40; higher scores represent greater self-efficacy.
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of social connectedness before and after the program
Description
Social connectedness will be assessed using the Social Connectedness Scale-Revised. The SCS-R, like its predecessor, measures social connectedness as a psychological sense of belonging or, more specifically, as a cognition of enduring interpersonal closeness with the social world in toto. The scale consists of 20 items (10 positive and 10 negative) rated on a 6-point Likert scale with higher scores represent better social connectedness
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of attitude towards elderly before and after the program
Description
Attitude towards elderly will be assessed using Kogan's (1961) Attitude toward Old People scale. The Attitude toward old people scale consists of 34 items grouped into two factors that assess positive and negative attitudes toward old people. Kogan's attitude toward old people consisted of 3 domains: personal appearance, resemblance, and the nature of interpersonal relations across age generations. The scores of the scale range from 34 to 204, with higher scores mean better attitude towards elderly
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of life satisfaction before and after the program
Description
Life satisfaction will be assessed using the satisfaction with life scale (SWLS).It is a 5-item scale designed to measure global cognitive judgments of one's life satisfaction (not a measure of either positive or negative affect). Participants will indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. Higher scores indicate better life satisfaction
Time Frame
baseline pre-intervention, 4.5 months when the program is completed
Title
The change of community involvement before and after the completion of the program
Description
Community involvement will be assessed by asking the participants their number of hours involved in elderly services six months after the completion of the program. Higher hours represent better community involvement
Time Frame
Six months after the completion of the program
Title
Recruitment rate after the completion of the program
Description
Recruitment rate will be obtained by asking the participant their working status at 6 months after the completion of the program. More people recruited to elderly service work, better the recruitment rate
Time Frame
6 months after the completion of the program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For older adults:
Inclusion Criteria:
aged 60 or above
having level of frailty from "managing well" to "living with severe frailty" (Clinical Frailty Scale score 3-7) -- HK-MoCA score 23 or less (add one point to people who had less than 6 year formal education and add 2 points to people who had no formal education)
Exclusion Criteria:
currently receiving any kind of rehabilitation service
living with another older adult who is participating in the same study.
For young adults:
Inclusion Criteria:
aged 17 to 35
having educational level of secondary 5 or above
Exclusion Criteria:
- having a full-time job
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arkers Wong, Ph.D.
Phone
34003805
Email
arkers.wong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arkers Wong, Ph.D.
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community center
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bob Liu
Phone
85229045647
Email
bob.liu@hklss.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects of a Tele-health Program
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