Wearable Monitoring Device in Daily Lives of Community-dwelling Older Adults

Device Ineffective Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269303
• Other study ID #: A001523
• Status: Completed
• Phase: N/A
• Start date: July 10, 2022
• Est. completion date: July 9, 2023

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 9, 2023
• Est. primary completion date: July 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• aged 60 or above

• own a smartphone

• able to communicate in Cantonese or Mandarin

• able to access the Internet at home or elsewhere

Exclusion Criteria:

• have a confirmed diagnosis of cognitive impairment

• bed-bound

• currently own a wearable monitoring device

• have already engaged in other wearable device studies

Related Conditions & MeSH terms

• Device Ineffective

Intervention

Device:
• Live With Wearable Monitoring Device program
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.

Locations

Country	Name	City	State
Hong Kong	Siu Sai Wan	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Secondary	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	Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Secondary	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	baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Secondary	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	baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points
Secondary	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.	baseline pre-intervention
Secondary	Attrition rate	The attrition rate refers to the number of participants who withdraw from the study or who are lost to follow up.	6-month (T3) time points
Secondary	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	6-month (T3) time points
Secondary	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	6-month (T3) time points
Secondary	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.	baseline pre-intervention, 6-month (T3) time points