Anti-wandering System for People With Intellectual Disability

NCT05785702 | Unknown

• 1 other identifier: Anti-wandering system_protocol
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study has 6 research questions regarding the use of the anti-wandering system in day activity centre cum hostel for persons with intellectual disabilities: Primary study questions:

1. 1.Can the anti-wandering system reduce the time in seconds to turn off the alarm made by the system (a proxy measure of the response time of care staff)?
2. 2.Can the anti-wandering system reduce the burden of care staff on keeping track of the residents?
3. 3.How many alarms does the anti-wandering system generate?
4. 4.How many false alarms does the anti-wandering system made as reported by staff?
5. 5.What are the reasons for keeping or loosening restrictions on users due to the use of the anti-wandering system?
6. 6.What are the perceived benefits and feasibility of anti-wandering system compared to conventional anti-wandering practices?

Conditions

Technology

Keywords

Gerontechnology; Anti-wandering system; Intellectual disability

Outcome Measures

Primary Outcomes (2)

• The time in seconds to turn off the alarm (a proxy measure of the response time of care staff in spotting residents in unauthorized areas)

  The time in seconds from the alarm going off to the alarm being turned off will be recorded by anti-wandering system.

  From the start of pre-test to the end of the 12-week trial period

• The burden of care staff on keeping track of the residents

  Care staff will complete five items indicating their burden in tracking of the participants under the anti-wandering system on a 5-point Likert scale (i.e. 1 indicating no burden and 5 indicating severe burden). The minimum and maximum values of the scale are 5 and 30 respectively, with higher score indicating care staff having burden. The contents include the perceived frequency of giving residents freedom of movement, feeling guilt in restricting residents, having conflicts with residents due to restricting them, and worrying residents to enter unauthorized areas unsupervised. At the end of the trial, they will fill in two additional questions of whether they have more time to handle other duties and whether they can better concentrate on other duties.

  Before the pre-test and the end of the 12-week trial period

Secondary Outcomes (5)

• The number of system alarms

  From the start of 4-week pre-test to the end of the 12-week trial period

• The number of false alarms reported by staff

  From the start to the end of the 12-week trial period

• The reasons for keeping or loosening restrictions on users due to the use of the anti-wandering system

  In the mid-term review meeting during the 12-week trial period

• The feasibility of anti-wandering system

  At the end of the 12-week trial period

• Qualitative measures: The perceived benefits and feasibility of anti-wandering system compared to conventional anti-wandering practices in care staff

  At the end of the 12-week trial period

Study Arms (1)

The anti-wandering system

EXPERIMENTAL

The experimental group will use the anti-wandering system 4-6-week of pre-test and 12-week of test trial.

Device: The anti-wandering system

Interventions

The anti-wandering system DEVICE

During the testing period, the system will promptly notify care staff if a participant enters unauthorized areas. A care staff will then go to that area and search for the participant. After the participant is found, care staff will reset the system, and then return the participant to a safe place.

The anti-wandering system

Eligibility Criteria

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

You may qualify if:

• Residents of the study sites
• Responsible for the operation of the anti-wandering system

You may not qualify if:

• Not independently mobile (i.e. unable to walk around without care staff assistance)
• Nil

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 (1)

Haven of Hope Residential Service for the Disabled

Hong Kong, 00, Hong Kong

RECRUITING

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Yee Tak Cheung, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yee Tak Cheung, PhD

CONTACT

+852 3917 6652; derekcheung@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: The trial is a single group pre-post test study at Haven of Hope Ming Tak Day Activity Centre. There will be a pre-test of 4-6 weeks and trial of 12 weeks. During pre-test, the alarm of the anti-wandering system will be muted, and the response time in spotting participants in selected unauthorized areas without system alarm can be recorded. During the trial period, the alarm will be turned on, so that care staff will be alerted when participants enter unauthorized area.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: September 25, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

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

Locations

HK (1)