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

Sensor-based Individualized Activity Management System for People With Dementia: Intervention Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05885620
Acronym
SAIN_UMR
Enrollment
40
Registered
2023-06-02
Start date
2020-11-10
Completion date
2022-11-10
Last updated
2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Assistive technology, User-centered design, Usability, Smartwatch, Dementia

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

Interventions

DEVICEdrinking reminder and cognitive task (smartwatch-based application)

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

Sponsors

German Center for Neurodegenerative Diseases (DZNE)
CollaboratorOTHER
Fraunhofer Institute
CollaboratorUNKNOWN
University of Rostock
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Successduring procedureObservation of success regarding to researchers' success protocol. Measurement is performed in the following: 1\) Live observation during procedure rated with 0, 0.5 or 1 point: 0 points: Participant shows no activity that could potentially lead to task fulfillment. 0.5 points: Participant intiated actions that result in incomplete task fulfillment. 1 point: Participant completely fullfilled the task (task A: drunk some water tasb B: circled something on the worksheet with the pencil). Only the best performance for each task was rated. Repetitions were not scored. The scores of both tasks were summarized, resulting in success values from 0 to 2 points.

Secondary

MeasureTime frameDescription
Usabilitydirectly after interventionMeasurement of perceived usability according to score calculated from 10 items of post-intervention questionnaire. Items were answered on a 5-step Likert scale. Negatively worded items were converted. Each item was rated with 0,1,2,3 or 4 corresponding to the answer on the Likert scale with the following direction: 0 is used for the strongest disagreement, 4 for strongest agreement. Then the sum of all scores is multiplied with 2.5, leading to possible usability scores from 0 to 100. Higher scores present better usability.
Designdirectly after interventionMeasurement of satisfaction with design assessed with 6 items of post-intervention questionnaire. Items were answered on a 5-step Likert scale. Each item was rated with 1,2,3, 4 or 5 corresponding to the answer on the Likert scale with the following direction: 1 is used for the strongest agreement, 5 for the strongest disagreement. Lower scores present higher satisfaction with design.
Usefulnessdirectly after interventionAssessment of perceived usefulness captured with 3 items of post-intervention questionnaire. Items were answered on a 5-step Likert scale. Each item was rated with 1,2,3, 4 or 5 corresponding to the answer on the Likert scale with the following direction: 1 is used for the strongest agreement, 5 for the strongest disagreement. Lower scores present higher perceived usefulness.
Concernsdirectly after interventionAssessment of concerns and barriers captured with 7 items of post-intervention questionnaire. Items were answered on a 5-step Likert scale. Each item was rated with 1,2,3, 4 or 5 corresponding to the answer on the Likert scale with the following direction: 1 is used for the strongest agreement, 5 for the strongest disagreement. Negatively worded items (5 items) were converted. Lower scores represent less concerns.

Other

MeasureTime frameDescription
User Experiencedirectly after interventionAssessment of overall user experience with questionnaire. Qualitative Data.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026