Clinical trial NCT06289322: AI4HOPE Dementia Pain Assessment Pilot Study 1
Official title: AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose and Endurance in Palliative Care for Dementia: Pilot Study 1 Digital Toolkit Assessment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: University College Cork
name: University of Leeds
name: Fundacion Intras
name: Universidade do Porto
name: University Medical Centre Maribor
First posted: 2024-03-01
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility and acceptability of toolkit
timeFrame: 7 days
measure: Accuracy of toolkit assessments
timeFrame: 7 days
Secondary outcomes:
measure: Effect of pain /distress interventions
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Department of Palliative Medicine, University Hospital Bonn
name: Lukas Radbruch, MD
role: PRINCIPAL_INVESTIGATOR
References: