Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289322
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-25
Brief Title:
AI4HOPE Dementia Pain Assessment Pilot Study 1
Sponsor:
University of Bonn
Organization:
University of Bonn
Study Overview
Official Title:
AI4HOPE - Artificial Intelligence Based Health Optimism Purpose and Endurance in Palliative Care for Dementia Pilot Study 1 Digital Toolkit Assessment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AI4HOPE1
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None