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Completed

NCT Number: NCT05269303

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

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.

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Key information

Conditions

Device Ineffective

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siu Sai Wan

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Live With Wearable Monitoring Device program

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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

  4. Recruitment rate

    Time frame: baseline pre-intervention

    The recruitment rate will be calculated by dividing the number of participants who are recruited and randomized, by the number of eligible participants.

  5. Attrition rate

    Time frame: 6-month (T3) time points

    The attrition rate refers to the number of participants who withdraw from the study or who are lost to follow up.

  6. Incidence of reports of adverse events

    Time frame: 6-month (T3) time points

    the incidence of reports of adverse events will be recorded by a staff member assigned to each of the community centres and a nurse

  7. Incidence of reports of technical difficulties

    Time frame: 6-month (T3) time points

    Incidence of reports of technical difficulties will be recorded by a staff member assigned to each of the community centres and a nurse

  8. 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

    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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Optimizing the Health-related Functions of a Wearable Monitoring Device in the Daily Life of Community-dwelling Older Adults: A Randomized Pilot Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2022
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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