Efficiency of an All-in-one Health Monitoring Device in Elderly Residential Setting

NCT05302895 | Completed FDA Device

• 1 other identifier: HKU_healthmonitor_protocol_v3
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

The study explores the benefits from the application of an all-in-one health monitoring device by care staff in old-age home setting: whether the average time consumed for measuring vital signs (including temperature, blood pressure and SpO2) will be shortened after the adoption of the new device. The study also assesses the satisfaction and perceived usability of the stakeholders towards the all-in-one health monitoring device.

Conditions

Technology

Keywords

Gerontechnology; Smart Healthcare Device; Digital Health Technology

Outcome Measures

Primary Outcomes (1)

• Average time required for health monitoring operation during the 12-week period

  The change in average daily operation time from using all-in-one health monitoring device compared to using traditional devices. The daily operation time from using all-in-one health monitoring device is recorded in log sheets by the staff.

  12 weeks

Secondary Outcomes (3)

• Qualitative measure: Perceived acceptance in using all-in-one health monitoring device

  at the end of 12-week trial period

• Qualitative measure: Perceived benefits in using all-in-one health monitoring device

  at the end of 12-week trial period

• Qualitative measure: Perceived concerns in using all-in-one health monitoring device

  at the end of 12-week trial period

Study Arms (1)

single-group

The health monitoring data of all the resident participants are measured using traditional device and the all-in-one health monitoring device on the same day for 12 weeks

Device: All-in-one health monitoring device

Interventions

All-in-one health monitoring device DEVICE

The staff will use the new monitoring device to carry out the health monitoring on every day during the 12-week period. After each round of health monitoring by the traditional and the new devices, the staff will need to fill in log sheets designed by HKU to document the time consumed for the entire process.

single-group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study populations are residents in Haven of Hope Woo Ping Care \& Attention Home, residents in Haven of Hope Nursing Home, and nurses, health workers, and/or family members of the residents

You may qualify if:

• are responsible for the supervision of the health monitoring procedure and those who are responsible for the operation of daily health monitoring
• are able to hold the all-in-one health monitoring device with his/her thumbs and index fingers of both hands under the assistance of the staff
• Having participated in the main trial
• Having participated in the main trial
• Able to verbally communicate in Cantonese as perceived by the staff of the related home
• Having witnessed the daily operation of the all-in-one health monitoring device

You may not qualify if:

• None
• Residents with implanted pacemakers and/or implanted cardio-defibrillators (ICDs)
• None
• None
• None

Sponsors & Collaborators

• The University of Hong Kong: lead
• Haven of Hope Hospital: collaborator
• The Social Innovation and Entrepreneurship Development Fund, Hong Kong: collaborator

Study Sites (2)

Haven of Hope Nursing Home

Hong Kong, Hong Kong

Location

Haven of Hope Woo Ping Care & Attention Home

Hong Kong, Hong Kong

Location

Related Publications (2)

• Piau A, Campo E, Rumeau P, Vellas B, Nourhashemi F. Aging society and gerontechnology: a solution for an independent living? J Nutr Health Aging. 2014 Jan;18(1):97-112. doi: 10.1007/s12603-013-0356-5.

  PMID: 24402399 BACKGROUND

• Carmeli, E. (2009). Aspects of assistive gerontechnology. International Journal on Disability and Human Development, 8(3), 215-218.

  BACKGROUND

Study Officials

• Yee Tak Cheung, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 31, 2022
• Study Start: May 12, 2022
• Primary Completion: August 19, 2022
• Study Completion: September 1, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for 10 years.

Locations

HK (2)