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RecruitingNCT06307197HAALUpdated Mar 12, 2024

HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia

An interventional study of HAAL platform in Dementia, Devices and Artificial Intelligence, sponsored by Istituto Nazionale di Ricovero e Cura per Anziani. Recruiting at 1 site in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Istituto Nazionale di Ricovero e Cura per Anziani · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Oct 2023, registered Mar 2024).
  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed 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).

02

Conditions studied

  • Dementia
  • Devices
  • Artificial Intelligence
  • Older People
  • Caregiver Burden

Keywords

  • dementia
  • caregiver
  • older people
  • technological devices
  • quality of life
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's planned enrollment of 10 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani is the lead sponsor of 41 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Lack of written informed consent
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    older adults

    Device: HAAL platform

Interventions

  • DeviceHAAL 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 1, 2, and 3 months later

07

Study locations

1 of 1 sites recruiting
  • IRCCS INRCA Hospital
    Ancona, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06307197
Lead sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Responsible party
Sponsor
First posted
Mar 12, 2024
Start date
Oct 2, 2023
Primary completion
Apr 15, 2024 (estimated)
Completion
Apr 15, 2024 (estimated)
Last update
Mar 12, 2024

Study contacts

Anna Rita Bonfigli
Contact
a.bonfigli@inrca.it
0718003719
Roberta Bevilacqua
study director · IRCCS INRCA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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