FrailtyNCT05267444
The Effects of a Tele-health Program
A study testing Individualized motion-based interactive game program in people with Frailty and Old Age; Debility, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Old Age; Debility
- What is being tested?
- Individualized motion-based interactive game program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 11 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- aged 17 to 35
- having educational level of secondary 5 or above
Who cannot join
- currently receiving any kind of rehabilitation service
- living with another older adult who is participating in the same study.
- For young adults:
- having a full-time job
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Frailty, Old Age; Debility
- Being tested
- Individualized motion-based interactive game program
- Keywords
- technology device, occupational therapy, young adult, frail older adults, self-care
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized motion-based interactive game programProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Individualized motion-based interactive game program Receives: Procedure: Individualized motion-based interactive game program |
| Control group | No intervention | The control group participants will receive usual care, that is, service that provided by community elderly center |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline pre-intervention, 4.5 months when the program is completed
Secondary outcomes (13)
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
Measured: baseline pre-intervention, 4.5 months when the program is completed
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
Measured: baseline pre-intervention, 4.5 months when the program is completed
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.
Measured: baseline pre-intervention, 4.5 months when the program is completed
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.
Measured: baseline pre-intervention, 4.5 months when the program is completed
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.
Measured: baseline pre-intervention, 4.5 months when the program is completed
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.
Measured: baseline pre-intervention, 4.5 months when the program is completed
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.
Measured: baseline pre-intervention, 4.5 months when the program is completed
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.
Measured: baseline pre-intervention, 4.5 months when the program is completed
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
Measured: baseline pre-intervention, 4.5 months when the program is completed
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
Measured: baseline pre-intervention, 4.5 months when the program is completed
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
Measured: baseline pre-intervention, 4.5 months when the program is completed
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
Measured: Six months after the completion of the program
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
Measured: 6 months after the completion of the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Jun 2022
- Primary completion11 Nov 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arkers, Wong, The Hong Kong Polytechnic University
- Investigators
- Arkers Wong, Ph.D., Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267444
- Sponsor's protocol ID
- P0036805
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05267444
- Acronym / sponsor ID
- P0036805
- Conditions
- Frailty, Old Age; Debility
- Keywords
- technology device, occupational therapy, young adult, frail older adults, self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Individualized motion-based interactive game programIndividualized motion-based interactive game program |
| Control group | No intervention | –The control group participants will receive usual care, that is, service that provided by community elderly center |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
- aged 17 to 35
- having educational level of secondary 5 or above
Key exclusion criteria (4 listed)
- currently receiving any kind of rehabilitation service
- living with another older adult who is participating in the same study.
- having a full-time job
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized motion-based interactive game programThe 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. | Procedure or surgery | Intervention group |
Primary outcome
The change of physical activity before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
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.
13 secondary outcomes
The change of balance before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of cognition status before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of short-term memory before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of loneliness level before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of social isolation before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of quality of life before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of depression level before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of self-efficacy before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of social connectedness before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of attitude towards elderly before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of life satisfaction before and after the program
Time frame: baseline pre-intervention, 4.5 months when the program is completed
The change of community involvement before and after the completion of the program
Time frame: Six months after the completion of the program
Recruitment rate after the completion of the program
Time frame: 6 months after the completion of the program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arkers Wong, Ph.D. principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized motion-based interactive game program in people with Frailty and Old Age; Debility, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of physical activity before and after the program (time frame: baseline pre-intervention, 4.5 months when the program is completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.