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

NCT ID: NCT05885620

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-10
• Study Completion Date: 2022-11-10

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

regular

components of interventions:

1. short vibration and short audio signal,

2. textual greeting,

3. textual prompt,

4. picture

5. short vibration

Group Type: ACTIVE_COMPARATOR

drinking reminder and cognitive task (smartwatch-based application)

Intervention Type: DEVICE

task A: prompt to drink some water task B: prompt to circle bells on a sheet

intense

components of interventions:

1. long vibration and long audio signal,

2. textual greeting,

3. textual prompt and speech output,

4. animation

5. long vibration

Group Type: ACTIVE_COMPARATOR

drinking reminder and cognitive task (smartwatch-based application)

Intervention Type: DEVICE

task A: prompt to drink some water task B: prompt to circle bells on a sheet

Interventions

drinking reminder and cognitive task (smartwatch-based application)

task A: prompt to drink some water task B: prompt to circle bells on a sheet

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Center for Neurodegenerative Diseases (DZNE)

OTHER

Sponsor Role: collaborator

Fraunhofer Institute

UNKNOWN

Sponsor Role: collaborator

University of Rostock

OTHER

Sponsor Role: lead

Responsible Party

Doreen Goerss

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doreen Görß, MD

Role: PRINCIPAL_INVESTIGATOR

Rostock University Medical Center

Locations

Rostock University Medical Center

Rostock, , Germany

Countries

Germany

References

Goerss D, Kohler S, Rong E, Temp AG, Kilimann I, Bieber G, Teipel S. Smartwatch-Based Interventions for People With Dementia: User-Centered Design Approach. JMIR Aging. 2024 Jun 7;7:e50107. doi: 10.2196/50107.

Reference Type: DERIVED

PMID: 38848116 (View on PubMed)

Other Identifiers

A 2020-0071

Identifier Type: -

Identifier Source: org_study_id