AI4HOPE Pilot Study 1 Digital Toolkit Assessment
ConditionDementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Bonn
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Digital toolkit for assessment
Other interventionThe 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Digital Toolkit for assessment of pain and distressOther 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility and acceptability of toolkit
Patient feedback on feasibility, usefulness and burden of toolkit
Time frame
7 days2
Accuracy of toolkit assessments
Comparison of toolkit assessments of pain and distress (including facial emotional recognition from weekly diary recordings) and PROM/PREM.
Time frame
7 daysSecondary outcomes
1
Effect of pain/distress interventions
Comparison of before/after assessments of interventions to alleviate pain or distress using the digital toolkit.
Time frame
7 days2
Exploration of specific linguistics and behavioural markers
Exploration of specific linguistics and behavioural markers and their correlation with clinical assess-ment tools' scores.
Time frame
Baseline, once per intervention week (at the end of the week)3
Technology usability and usage metrics
PROM/PREM completion rates, user engagement patterns, and dropout analysis.
Time frame
At the end of intervention4
Feedback on the diary interface
Feedback on the diary interface and user experience that could inform future iterations.
Time frame
At the end of interventionLocations
Sponsors and contacts
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University of Bonn
Lead sponsor
University Hospital, Bonn
Sponsor institution
University College Cork
Collaborator
University of Leeds
Collaborator
Fundacion Intras
Collaborator
Universidade do Porto
Collaborator
University Medical Centre Maribor
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: