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

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.

Study Overview

• Status: Completed
• Conditions: Device Ineffective
• Intervention / Treatment: Device: Live With Wearable Monitoring Device program

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Siu Sai Wan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants will receive a 3-month Live With Wearable Monitoring Device program.	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.
No Intervention: Control group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Arkers Wong, Ph.D., The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2022
• Primary Completion (Actual): July 9, 2023
• Study Completion (Actual): July 9, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: community-dwelling older adults; Wearable monitoring device
• Other Study ID Numbers: A001523

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