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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Device Ineffective

Intervention / Treatment
-----------------
* Device: Live With Wearable Monitoring Device program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will receive a 3-month Live With Wearable Monitoring Device program. | Device: Live With Wearable Monitoring Device program<br>* 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.<br>|
| No Intervention: Control group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
community-dwelling older adults, Wearable monitoring device