Clinical trial NCT05885620: SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia
Official title: Sensor-based Individualized Activity Management System for People With Dementia: Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Alzheimer Disease
Dementia With Lewy Bodies
Dementia, Vascular
Dementia, Mixed
Dementia Frontotemporal
Keywords: Assistive technology
User-centered design
Usability
Smartwatch
Dementia
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: German Center for Neurodegenerative Diseases (DZNE)
name: Fraunhofer Institute
First posted: 2023-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Assistive Technologies (ATs) can help people living with dementia (PwD) maintain their everyday activity. Still, there is a gap between potential and supply. Involving future users can close the gap. But the value of participation from PwD is unclear.

The study examined smartwatch interactions from people with dementia or with mild cognitive impairment. Participants received "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts on a customized smartwatch to perform everyday tasks. Participants' reactions were observed via cameras. Users' feedback was captured with questionnaires.

Detailed description: This was a mixed methods study involving different stakeholder groups in a stepwise approach towards the user-centered evaluation of a smartwatch-based application for PwD. A preparatory qualitative study focused on identifying needs and requirements for mobile assistive devices. An observatory field study revealed potential use cases for smartwatches for persons with dementia. The subsequent intervention study examined smartwatch interactions and gathered users' feedback concerning usability, design, usefulness and concerns. Participants with mild cognitive impairment or dementia received either "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts to perform everyday tasks. All participants were prompted to complete two tasks, prompts were repeated up to three times if they failed to completely solve a task. Prompts were triggered using a smartphone as remote control. Patient reactions were observed via video cameras. Each task was rated with 1 point for success, 0.5 for incomplete task fulfillment or 0 for failure. Both tasks were summarized, resulting in success values from 0 to 2 points.

Abbreviations:

PwD: people with dementia MCI: mild cognitive impairment AT: assistive technology

Eligibility criteria: Inclusion Criteria:

* diagnosis of mild cognitive impairment or dementia
* Mini Mental Status Examination (MMSE) ≥ 9 and ≤ 28 points

Exclusion Criteria:

* clinically relevant impairment of visual acuity and/or hearing
* relevant speech/language impairment

Primary outcomes:
measure: Success
timeFrame: during procedure
Secondary outcomes:
measure: Usability
timeFrame: directly after intervention
measure: Design
timeFrame: directly after intervention
measure: Usefulness
timeFrame: directly after intervention
measure: Concerns
timeFrame: directly after intervention
Other outcomes:
measure: User Experience
timeFrame: directly after intervention
Locations:
city: Rostock
country: Germany
facility: Rostock University Medical Center
Study officials:
affiliation: Rostock University Medical Center
name: Doreen Görß, MD
role: PRINCIPAL_INVESTIGATOR
References: