Anti-wandering System for People With Intellectual Disability

Study design

The trial is a single group pre-post test study at Haven of Hope Ming Tak Day Activity Centre and Hostel and Haven of Hope Sau Mau Ping Day Activity Centre Cum Hostel. There will be a pre-test of 4 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.

This protocol complies with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Guideline for Good Clinical Practice (ICH-GCP) and Declaration of Helsinki.

Procedures

1. Participants' selection and consent If it is feasible to install radio frequency identification (RFID) tags on all the clothes of all the residents in the study sites, all of them will be invited to participate in the trial. If this is not feasible, priority will be given to those who have higher risk in wandering (i.e. have a history of running off, attempting to leave authorized areas, or entering unauthorized areas). Participants and their family members will be notified about the utilization of the anti-wandering system and installation of the RFID tags in participants' clothes. If they do not want to participate, they can notify the care staff (Opt-out participation). For care staff, it will be presumed that they agree to participate in the study if they complete the anonymous questionnaire (i.e. implied consent) on that assesses the burden of care staff on keeping track of the residents. Written consent will be obtained from care staff before qualitative interview.
2. System installation The system installation includes installing the RFID sensors in the entrances of the kitchen, laundry room, storage room, activity room and pharmacy, inserting RFID tags (size about 4cm x 1cm x 0.3cm) in the participants' clothes, and installing related software(s) in computers in the general office. The service unit and the product supplier shall discuss the installation plan.
3. 1-month pre-test The objective of the pre-test period (Week 1 to Week 4) is to collect baseline data on the time it takes the care staff to spot a resident who has entered an unauthorized area. During the pre-test period, the alarm of the anti-wandering system will be muted. Existing anti-wandering measures will be maintained, including locking unauthorized areas, setting up carts or barriers at the entrance of the unauthorized areas, having staff stay in the unauthorized areas when the doors of the areas are open, and forbidding residents hanging around during certain time of the day. When care staff spots a resident in an unauthorized area, he or she will reset the anti-wandering system and then return the resident to a safe place. During the process, the system will record the response time of the care staff without system alarm. Reminders on contacting the general office staff to reset the anti-wandering system will be posted in unauthorized areas.
4. Training for care staff A few identical 1-hour training sessions will be provided to care staff. The supplier will instruct and demonstrate to care staff how to use the anti-wandering system. The University of Hong Kong (HKU) researcher will then explain the test flow and data collection. This training will be recorded so that care staff can re-watch it. A protocol with related operations will be provided to care staff.
5. Implementation

During the testing period, the system will promptly notify care staff if a participant enters unauthorized areas (e.g. the speaker installed at the hallway and monitor at the general office will broadcast and display the bed number of the participant and their position). A care staff will then go to that area and search for the participant. After the participant is found, care staff will contact the staff in the general office to reset the system, and then return the participant to a safe place. At the end of each shift, care staff will document any abnormal events, as determined by the care staff, during the use of the new anti-wandering system in a log book. HKU researcher will analyze the record to determine whether the alarm generated by the system is false or not. This experience will be used to revise the operation protocol.

Blinding

No blinding will be done for this single group study.

Sample size determination

The number of residents is estimated by the number of the residents residing in the study sites. The number of care staff is estimated by the number of related staff working in the study sites. It is expected that 40 residents and 20 care staff will be recruited.

Data analyses

1. Main analysis Independent sample t-test will be used to test the difference of the response time and the anonymous data of care staff burden (including 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) between pre-test (from Week 1 to Week 4) and main trial (from Week 5 to Week 16). Descriptive statistics will be used to examine whether the care staff have more time to handle other duties and whether they can better concentrate on other duties.
2. Process evaluations The number of alarms generated by the system, the number of false alarms reported by care staff, and the number of missing person report will be counted. False alarm rate will be calculated by dividing the number of false alarms by the total number of alarms. The reasons for keeping or loosening restrictions on users due to the use of the anti-wandering system will be summarised.
3. Qualitative interview

The interview content will be transcribed verbatim in Chinese for further analysis. The qualitative interview transcripts will be analyzed by using framework analysis to construct a coherent and logical structure from the classification of many opinions and perceptions of the anti-wandering system. The results will then be discussed and consolidated in the panel meetings with the co-authors.