AI4HOPE Pilot Study 1 Digital Toolkit Assessment

NCT06289322 | Not Yet Recruiting

• 1 other identifier: EU101136769-CLIN1
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (2)

• Feasibility and acceptability of toolkit

  Patient feedback on feasibility, usefulness and burden of toolkit

  7 days

• Accuracy of toolkit assessments

  Comparison of toolkit assessments of pain and distress (including facial emotional recognition from weekly diary recordings) and PROM/PREM.

  7 days

Secondary Outcomes (4)

• Effect of pain/distress interventions

  7 days

• Exploration of specific linguistics and behavioural markers

  Baseline, once per intervention week (at the end of the week)

• Technology usability and usage metrics

  At the end of intervention

• Feedback on the diary interface

  At the end of intervention

Study Arms (1)

Digital Toolkit for assessment of pain and distress

OTHER

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.

Other: Digital toolkit for assessment

Interventions

Digital toolkit for assessment OTHER

The pilot study uses a digital assessment and intervention toolkit. The person with dementia and caregivers may choose from the digital interventions offered in the toolbox without any mandatory conditions.

Digital Toolkit for assessment of pain and distress

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bonn: lead
• University College Cork: collaborator
• University of Leeds: collaborator
• Fundacion Intras: collaborator
• Universidade do Porto: collaborator
• University Medical Centre Maribor: collaborator

MeSH Terms

Conditions

Dementia

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Lukas Radbruch, MD

  Department of Palliative Medicine, University Hospital Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Radbruch, MD

CONTACT

+4922828713495; lukas.radbruch@ukbonn.de

Holger Brunsch, Dr.

CONTACT

+49 228 287 10309; holger.brunsch@ukbonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Department of Palliative Medicine, University Hospital Bonn

Model Details: Feasibility study

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share