HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia

Not Applicable

Recruiting

• Conditions: Devices; Artificial Intelligence; Dementia; Caregiver Burden; Older People
• Interventions: Device: HAAL platform

• Registration Number: NCT06307197
• Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani

Brief 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.

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).

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-02
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
older adults	HAAL platform	-

Primary Outcome Measures

Name	Time	Method
Care load of caregivers	baseline, 1, 2, and 3 months later	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.

Trial Locations

Locations (1)

IRCCS INRCA Hospital; 🇮🇹 Ancona, Italy