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NCT Number: NCT06292143

AI4HOPE Pilot Study 2 Digital Dementia Care Planning

This pilot study will test a digital care planning decision support system for patients with dementia.

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Key information

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 for advance care planning and decision making for patients with dementia and pilot-test this digital support system for feasibility and acceptability.

Other workpackages of the AI4HOPE project will design a digital technology platform to provide relevant, timely and appropriate information for people with dementia and their carers, and to facilitate them to document their goals, wishes, and preferences for future care.

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 develop a digital technology platform to facilitate ACP for clinical practice in any patient with cognitive impairment from any type of dementia.

Even though the digital platform could be adapted to be useful for patients with advanced dementia and more severe cognitive impairment, or for use just by their families, 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 for patient-related outcome or patient-related experience measures to inform the assessment of the digital technology platform.

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 up to 90 days, with optional extension to 180 days according to patients' preferences.

Patients with baseline data and at least one interaction with the digital platform and data completed before and after that interaction 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 or moderate dementia of any type
  • Montreal 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 conditions preventing the use of wearable body sensors

Treatment and study plan

Advance Care Planning Toolkit

Other

Participants or their caregivers will access the digital platform for advance care planning

Primary outcomes

  1. Feasibility and acceptability of digital ACP-platform, the Dementia Journey Companion (DJC)

    Time frame: 30 days

    Participant feedback on feasibility, usefulness and burden of ACP-platform; acceptability of content included in the ACP-platform for participantd, user satisfaction with conversational support and suc-cess rate in achieving communicative goals, answering questions and providing guidance.

Secondary outcomes

  1. Effect of DJC on documentation of ACP

    Time frame: 30 days

    Rating of benefit by health care professionals.

  2. Completion rate of preference documentation

    Time frame: 30 days

    Completion rate of preference documentation across domains (daily living, medical, end-of-life) and frequency of use; frequency of chatbot interactions; number of memories, stories, and preferences documented.

  3. Assessment of pain, distress and anxiety

    Time frame: 30 days

    Assessment of pain, distress and anxiety (PROM as part of assessment toolkit).

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]

+4915158233747

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 Ofr Dementia: Pilot Study 2 Digital Dementia Care Planning

Acronym: AI4HOPE2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2024
Registry last updated
Feb 2, 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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