HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia

Dementia Clinical Trial

— HAAL  

Official title:

HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307197
• Other study ID #: INRCA_008_2023
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: October 2023
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: Anna Rita Bonfigli
• Phone: 0718003719
• Email: a.bonfigli[@]inrca.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

HAAL project aims to test several technological devices in order to improve the quality of life of older people with dementia and their informal and formal caregiver.

Description:

The HAAL study is a feasibility study. The general objectives of the HAAL project is to be assessed the stress relief at work for formal and informal caregivers, the improvement in the perceived quality of life for informal caregivers and person with dementia, the reduction in case load for the formal caregivers and the increased cost-effectiveness of the HAAL solution in comparison to the available services. The experimentation will be carried out in 3 sites: Italy, The Netherlands and Taiwan. The study consists in a alpha phase (5 older adults with dementia, 5 formal caregivers and 5 formal caregivers) and in a beta phase (10 older adults with dementia, 10 formal caregivers and 10 formal caregivers).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• being the caregiver of a person with cognitive impairment or dementia;

• availability of time to participate;

• visit the assisted person at least two times at week or live with him/her.

Exclusion Criteria:

• Lack of written informed consent

Related Conditions & MeSH terms

• Artificial Intelligence
• Caregiver Burden
• Dementia
• Older People

Intervention

Device:
• HAAL platform
The HAAL platform is composed by 6 devices (lifestyle monitoring system, a smart mattress, a GPS tracking system, a social robot, an interactive game for cognitive training, and an alarm system), 1 tablet and 1 dashboard. Each user benefits of a combination of such devices, according to its own needs. The dashboard, that is used by the Formal Caregiver, receives, analyses, and show data acquired by those devices. The platform uses Artificial Intelligence (AI) algorithms - in particular machine learning (ML) is used - to analyse the collected data. The main reason for using AI in HAAL is that the platform collects data from different sensors.

Locations

Country	Name	City	State
Italy	IRCCS INRCA Hospital	Ancona

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Care load of caregivers	The burden of the caregiver will be assessed through the ZARIT Burden Interview (ZBI). The ZBI is a caregiver self-report measure, containing 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).Total score range: 0 to 88. score range 0-21: no to mild burden; score range 21-40: mild to moderate burden; score range 41-60: moderate to severe burden score = 61: severe burden.	baseline, 1, 2, and 3 months later