- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05267444
The Effects of a Tele-health Program
February 27, 2024 updated by: Arkers, Wong, The Hong Kong Polytechnic University
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
202
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arkers Wong, Ph.D.
- Phone Number: 34003805
- Email: arkers.wong@polyu.edu.hk
Study Locations
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Hong Kong, Hong Kong
- Community center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Individualized motion-based interactive game program
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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.
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No Intervention: Control group
The control group participants will receive usual care, that is, service that provided by community elderly center
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of physical activity before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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.
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baseline pre-intervention, 4.5 months when the program is completed
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of balance before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
|
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
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baseline pre-intervention, 4.5 months when the program is completed
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The change of cognition status before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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
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baseline pre-intervention, 4.5 months when the program is completed
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The change of short-term memory before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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.
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baseline pre-intervention, 4.5 months when the program is completed
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The change of loneliness level before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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.
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baseline pre-intervention, 4.5 months when the program is completed
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The change of social isolation before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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.
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baseline pre-intervention, 4.5 months when the program is completed
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The change of quality of life before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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.
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baseline pre-intervention, 4.5 months when the program is completed
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The change of depression level before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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.
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baseline pre-intervention, 4.5 months when the program is completed
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The change of self-efficacy before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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.
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baseline pre-intervention, 4.5 months when the program is completed
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The change of social connectedness before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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
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baseline pre-intervention, 4.5 months when the program is completed
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The change of attitude towards elderly before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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
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baseline pre-intervention, 4.5 months when the program is completed
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The change of life satisfaction before and after the program
Time Frame: baseline pre-intervention, 4.5 months when the program is completed
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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
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baseline pre-intervention, 4.5 months when the program is completed
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The change of community involvement before and after the completion of the program
Time Frame: Six months after the completion of the program
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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
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Six months after the completion of the program
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Recruitment rate after the completion of the program
Time Frame: 6 months after the completion of the program
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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
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6 months after the completion of the program
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arkers Wong, Ph.D., The Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
November 11, 2023
Study Completion (Actual)
November 11, 2023
Study Registration Dates
First Submitted
February 24, 2022
First Submitted That Met QC Criteria
February 24, 2022
First Posted (Actual)
March 4, 2022
Study Record Updates
Last Update Posted (Estimated)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 27, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0036805
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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