Skip to main content
OpenTrials
Completed

NCT Number: NCT05885620

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dementia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Dementia Frontotemporal Dementia With Lewy Bodies Dementia, Mixed Dementia, Vascular Frontotemporal Dementia Frontotemporal Lobar Degeneration Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Mental Disorders Mild Cognitive Impairment Mixed Dementias Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Pick Disease of the Brain Synucleinopathies Tauopathies Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rostock University Medical Center

Rostock, 18057, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

drinking reminder and cognitive task (smartwatch-based application)

Device

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

Primary outcomes

  1. Success

    Time frame: during procedure

    Observation of success regarding to researchers' success protocol.

    Measurement is performed in the following:

    • 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 outcomes

  1. Usability

    Time frame: directly after intervention

    Measurement 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.

  2. Design

    Time frame: directly after intervention

    Measurement 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.

  3. Usefulness

    Time frame: directly after intervention

    Assessment 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.

  4. Concerns

    Time frame: directly after intervention

    Assessment 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 outcomes

  1. User Experience

    Time frame: directly after intervention

    Assessment of overall user experience with questionnaire. Qualitative Data.

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Collaborators

  • Fraunhofer Institute
  • German Center for Neurodegenerative Diseases (DZNE)

Registry information

Official study title

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

Acronym: SAIN_UMR

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 2, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.