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NCT Number: NCT06289322

AI4HOPE Pilot Study 1 Digital Toolkit Assessment

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility and acceptability of toolkit

    Time frame: 7 days

    Patient feedback on feasibility, usefulness and burden of toolkit

  2. Accuracy of toolkit assessments

    Time frame: 7 days

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

Secondary outcomes

  1. Effect of pain/distress interventions

    Time frame: 7 days

    Comparison of before/after assessments of interventions to alleviate pain or distress using the digital toolkit.

  2. Exploration of specific linguistics and behavioural markers

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

    Exploration of specific linguistics and behavioural markers and their correlation with clinical assess-ment tools' scores.

  3. Technology usability and usage metrics

    Time frame: At the end of intervention

    PROM/PREM completion rates, user engagement patterns, and dropout analysis.

  4. Feedback on the diary interface

    Time frame: At the end of intervention

    Feedback on the diary interface and user experience that could inform future iterations.

Study contacts

Contact information is provided by the study sponsor or research team.

Holger Brunsch, Dr.

CONTACT

[email protected]

+49 228 287 10309

Lukas Radbruch, MD

CONTACT

[email protected]

+4922828713495

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Collaborators

  • Fundacion Intras
  • Universidade do Porto
  • University College Cork
  • University Medical Centre Maribor
  • University of Leeds

Registry information

Official study title

AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose and Endurance in Palliative Care for Dementia: Pilot Study 1 Digital Toolkit Assessment

Acronym: AI4HOPE1

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2024
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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