NCT06307197

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

March 12, 2024

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

March 4, 2024

Last Update Submit

March 8, 2024

Conditions

Keywords

dementiacaregiverolder peopletechnological devicesquality of life

Outcome Measures

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.

    baseline, 1, 2, and 3 months later

Study Arms (1)

older adults

EXPERIMENTAL
Device: HAAL platform

Interventions

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.

older adults

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Lack of written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS INRCA Hospital

Ancona, Italy

RECRUITING

MeSH Terms

Conditions

DementiaCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Roberta Bevilacqua

    IRCCS INRCA

    STUDY DIRECTOR

Central Study Contacts

Anna Rita Bonfigli

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

October 2, 2023

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

March 12, 2024

Record last verified: 2023-10

Locations