AI4HOPE Dementia Pain Assessment Pilot Study 1

Not Applicable

Not yet recruiting

• Conditions: Dementia
• Interventions: Other: Digital toolkit for assessment

• Registration Number: NCT06289322
• Lead Sponsor: University of Bonn

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-02-25
• Status Verified: 2024-03
• Study First Posted: 2024-03-01
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-05
• Study Start: 2025-07
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Mild or moderate dementia of any type
• Able to provide informed consent, or consent from surrogate decision maker
• Able to self-assess patient-related outcome (PROM) or experience (PREM) measures

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Exclusion Criteria

• Ongoing delir
• Severe cognitive impairment (MMSE < 10 [22])
• Unable to provide informed consent
• Life expectancy estimated less than 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital Toolkit for assessment of pain and distress	Digital toolkit for assessment	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

Primary Outcome Measures

Name	Time	Method
Accuracy of toolkit assessments	7 days	comparison of toolkit assessments of pain and distress (including facial emotional recognition) and PROM/PREM
Feasibility and acceptability of toolkit	7 days	patient feedback on feasibility, usefulness and burden of toolkit

Secondary Outcome Measures

Name	Time	Method
Effect of pain /distress interventions	7 days	comparison of before/after assessments of interventions to alleviate pain or distress using the digital toolkit