SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia (SAIN_UMR)

University of Rostock

Status: Completed

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia Frontotemporal; Dementia, Vascular; Dementia With Lewy Bodies; Dementia; Dementia, Mixed

Treatments: Device: drinking reminder and cognitive task (smartwatch-based application)

Study type: Interventional

Funder types: Other

Identifiers

NCT05885620

A 2020-0071

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

regular

Active Comparator group

Description:

components of interventions: 1. short vibration and short audio signal, 2. textual greeting, 3. textual prompt, 4. picture 5. short vibration

Treatment:

Device: drinking reminder and cognitive task (smartwatch-based application)

intense

Active Comparator group

Description:

components of interventions: 1. long vibration and long audio signal, 2. textual greeting, 3. textual prompt and speech output, 4. animation 5. long vibration

Treatment:

Device: drinking reminder and cognitive task (smartwatch-based application)