AI4HOPE Pilot Study 1 Digital Toolkit Assessment (AI4HOPE1)

University of Bonn

Status: Not yet enrolling

Conditions: Dementia

Treatments: Other: Digital toolkit for assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06289322

EU101136769-CLIN1

Details and patient eligibility

About

The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired patients with dementia.

Full description

The clinical study is part of an EU-funded project on the use of artificial intelligence for patients with dementia. This study will test a digital toolkit fo assessment and monitoring of patients with mild or moderate dementia and pilot-test this toolkit for feasibility and acceptability.

Patients with mild to moderate dementia will be recruited for the pilot study in the six participating countries. The study population includes all types of dementia without stratification, as the aim of the study is to construct a digital assessment and intervention toolkit for clinical practice in any patient with cognitive impairment from any type of dementia.

Even though the final assessment and intervention toolkit could also be useful for patients with advanced dementia and more severe cognitive impairment, the pilot study will recruit only patients with mild or moderate dementia, who will still be able to provide informed consent, and who will be able to self-assess at least minimum patient-related outcome or patient-related experience measures to validate the behavioural and observational scales and biomarkers used in the toolkit.

Patients with dementia treated in the participating study centers will be screened for inclusion criteria and, if suitable will be invited to participate. The study will be performed for seven days, with optional extension to 30 days according to patients' preferences.

Patients with baseline data and at least one intervention performed from the digital toolkit and data completed before and after that intervention will be included in the evaluation.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild to moderate dementia of any type
• Montrea Cognitive Assessment (MoCA) score of 16-25
• Living at home, or in residential or nursing home care
• Receiving adequate social support

Exclusion criteria

• Moderate/severe cognitive impairment (MoCA < 16)
• No cognitive impairment (MoCA >25)
• Inpatient or acute hospital treatment
• Infectious diseases or lokal skin conditons preventing the use of wearable body sensors

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Digital Toolkit for assessment of pain and distress

Other group

Description:

A digital toolkit will be developed using facial emotional recognition and other instruments as well as questionnaires for the assessment of pain and distress in patients with dementia.

Treatment:

Other: Digital toolkit for assessment