Device IneffectiveNCT05269303
Wearable Monitoring Device in Daily Lives of Community-dwelling Older Adults
A study testing Live With Wearable Monitoring Device program in people with Device Ineffective, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The aim is to implement an intervention program to promote the continued use of Wearable Monitoring Devices among older adults through a peer support approach facilitating the incorporation of Wearable Monitoring Devices in daily life. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Device Ineffective
- What is being tested?
- Live With Wearable Monitoring Device program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Jul 2022to 9 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 60 or above
- own a smartphone
- able to communicate in Cantonese or Mandarin
- able to access the Internet at home or elsewhere
Who cannot join
- have a confirmed diagnosis of cognitive impairment
- bed-bound
- currently own a wearable monitoring device
- have already engaged in other wearable device studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing the Health-related Functions of a Wearable Monitoring Device in the Daily Life of Community-dwelling Older Adults: A Randomized Pilot Study
The aim is to implement an intervention program to promote the continued use of Wearable Monitoring Devices among older adults through a peer support approach facilitating the incorporation of Wearable Monitoring Devices in daily life.
- Conditions
- Device Ineffective
- Being tested
- Live With Wearable Monitoring Device program
- Keywords
- community-dwelling older adults, Wearable monitoring device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live With Wearable Monitoring Device programDevice
The participants in the intervention group will receive a home visit by a Community Healthcare Worker in the first month, and biweekly motivational messages via Whats App in the second and third months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive a 3-month Live With Wearable Monitoring Device program. Receives: Device: Live With Wearable Monitoring Device program |
| Control group | No intervention | Usual care. As with the participants in the intervention group, those in the control group can utilize the features in the Wearable Monitoring Device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of use intention of wearable monitoring device
It will be measured using a 4-item, 5-point Likert scale adopted from Bhattacherjee (2001) and Windasari et al. (2021). The five-point scale ranges from 1 = not at all satisfied to 5 = very certain, with higher scores representing a higher chance of continuing to use the WMD.
Measured: Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Secondary outcomes (8)
The change of adherence rate of wearing wearable monitoring device
It will be measured by checking in our database the number of days that participants wore their device, and the average amount of time worn per day. Longer time worn represents better adherence rate
Measured: Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
The change in quality of life among baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Quality of life will be measured using the Hong Kong version of the EuroQol 5-dimension scale. The EQ-5D-5L is comprised of five dimensions, namely, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The utility score ranges from 0 to 1, with higher means better quality of life
Measured: baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
The change of health service utilization among baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
ealth service utilization includes the number of attendances at a general practitioner's office, emergency department, hospital, and general out-patient clinic. The data will be reported by the participants and confirmed with medical and attendance certificates
Measured: baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Recruitment rate
The recruitment rate will be calculated by dividing the number of participants who are recruited and randomized, by the number of eligible participants.
Measured: baseline pre-intervention
Attrition rate
The attrition rate refers to the number of participants who withdraw from the study or who are lost to follow up.
Measured: 6-month (T3) time points
Incidence of reports of adverse events
the incidence of reports of adverse events will be recorded by a staff member assigned to each of the community centres and a nurse
Measured: 6-month (T3) time points
Incidence of reports of technical difficulties
Incidence of reports of technical difficulties will be recorded by a staff member assigned to each of the community centres and a nurse
Measured: 6-month (T3) time points
The change of perceived usability of the wearable monitoring device before and after the program
The participants will be required to complete a questionnaire that measures their attitude towards using the WMD; the perceived usefulness, perceived ease of use, and self-efficacy of using the device; and their level of anxiety about using the device. The questionnaire was drawn up by Chen and Chan (2014). This 10-point Likert scale ranges from 1 (strongly disagree) to 10 (strongly agree), with higher marks indicating a better outcome, with the exception of the item on anxiety levels, where higher marks represent a higher level of anxiety in using the WMD.
Measured: baseline pre-intervention, 6-month (T3) time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start10 Jul 2022
- Primary completion9 Jul 2023
- Study completion9 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Device IneffectiveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 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
- NCT05269303
- Sponsor's protocol ID
- A001523
- Status last verified
- Sep 2023
- First submitted
- 24 Feb 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong AKC, Bayuo J, Su JJ, Wong FKY, Chow KKS, Wong BP, Wong SM, Hui V. Effectiveness of the Support From Community Health Workers and Health Care Professionals on the Sustained Use of Wearable Monitoring Devices Among Community-Dwelling Older Adults: Feasibility Randomized Controlled Trial. J Med Internet Res. 2024 Nov 18;26:e52435. doi: 10.2196/52435.
PubMed 39556810Wong AKC, Tso WC, Su JJ, Hui VCC, Chow KKS, Wong SM, Wong BB, Wong FKY. Effectiveness of support from community health workers on the sustained use of a wearable monitoring device among community-dwelling older adults: A randomized trial protocol. PLoS One. 2023 Dec 22;18(12):e0294517. doi: 10.1371/journal.pone.0294517. eCollection 2023.
PubMed 38134126
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Health-related Functions of a Wearable Monitoring Device in the Daily Life of Community-dwelling Older Adults: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05269303
- Acronym / sponsor ID
- A001523
- Conditions
- Device Ineffective
- Keywords
- community-dwelling older adults, Wearable monitoring device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 9 Jul 2023 (actual)
- Study completion
- 9 Jul 2023 (actual)
- First posted
- 7 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.
The aim is to implement an intervention program to promote the continued use of Wearable Monitoring Devices among older adults through a peer support approach facilitating the incorporation of Wearable Monitoring Devices in daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Live With Wearable Monitoring Device programParticipants will receive a 3-month Live With Wearable Monitoring Device program. |
| Control group | No intervention | –Usual care. As with the participants in the intervention group, those in the control group can utilize the features in the Wearable Monitoring Device. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 60 or above
- own a smartphone
- able to communicate in Cantonese or Mandarin
- able to access the Internet at home or elsewhere
Key exclusion criteria (4 listed)
- have a confirmed diagnosis of cognitive impairment
- bed-bound
- currently own a wearable monitoring device
- have already engaged in other wearable device studies
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 |
|---|---|---|
| Live With Wearable Monitoring Device programThe participants in the intervention group will receive a home visit by a Community Healthcare Worker in the first month, and biweekly motivational messages via Whats App in the second and third months. | Device | Intervention group |
Primary outcome
The change of use intention of wearable monitoring device
Time frame: Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
It will be measured using a 4-item, 5-point Likert scale adopted from Bhattacherjee (2001) and Windasari et al. (2021). The five-point scale ranges from 1 = not at all satisfied to 5 = very certain, with higher scores representing a higher chance of continuing to use the WMD.
8 secondary outcomes
The change of adherence rate of wearing wearable monitoring device
Time frame: Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
The change in quality of life among baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Time frame: baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
The change of health service utilization among baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Time frame: baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Recruitment rate
Time frame: baseline pre-intervention
Attrition rate
Time frame: 6-month (T3) time points
Incidence of reports of adverse events
Time frame: 6-month (T3) time points
Incidence of reports of technical difficulties
Time frame: 6-month (T3) time points
The change of perceived usability of the wearable monitoring device before and after the program
Time frame: baseline pre-intervention, 6-month (T3) time points
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 22 Sep 2023.
- Derived from this study: PubMed 39556810Wong AKC, Bayuo J, Su JJ, Wong FKY, Chow KKS, Wong BP, Wong SM, Hui V. Effectiveness of the Support From Community Health Workers and Health Care Professionals on the Sustained Use of Wearable Monitoring Devices Among Community-Dwelling Older Adults: Feasibility Randomized Controlled Trial. J Med Internet Res. 2024 Nov 18;26:e52435. doi: 10.2196/52435.
- Derived from this study: PubMed 38134126Wong AKC, Tso WC, Su JJ, Hui VCC, Chow KKS, Wong SM, Wong BB, Wong FKY. Effectiveness of support from community health workers on the sustained use of a wearable monitoring device among community-dwelling older adults: A randomized trial protocol. PLoS One. 2023 Dec 22;18(12):e0294517. doi: 10.1371/journal.pone.0294517. eCollection 2023.
- Individual participant dataSharing planned: No
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 Live With Wearable Monitoring Device program in people with Device Ineffective, 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 22 Sep 2023. 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 use intention of wearable monitoring device (time frame: Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05269303, which also lists 2 linked publications.
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 22 Sep 2023.