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

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Mild Cognitive Impairment; Dementia, Vascular; Dementia, Mixed; Dementia With Lewy Bodies; Dementia Frontotemporal
• Intervention / Treatment: Device: drinking reminder and cognitive task (smartwatch-based application)

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rostock, Germany, 18057
    • Rostock University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: regular; components of interventions: short vibration and short audio signal,; textual greeting,; textual prompt,; picture; short vibration	Device: drinking reminder and cognitive task (smartwatch-based application); task A: prompt to drink some water task B: prompt to circle bells on a sheet
Active Comparator: intense; components of interventions: long vibration and long audio signal,; textual greeting,; textual prompt and speech output,; animation; long vibration	Device: drinking reminder and cognitive task (smartwatch-based application); task A: prompt to drink some water task B: prompt to circle bells on a sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success	Observation 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.	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	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.	directly after intervention
Design	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.	directly after intervention
Usefulness	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.	directly after intervention
Concerns	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.	directly after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Experience	Assessment of overall user experience with questionnaire. Qualitative Data.	directly after intervention

Collaborators and Investigators

• Sponsor: University of Rostock
• Collaborators: German Center for Neurodegenerative Diseases (DZNE); Fraunhofer Institute
• Investigators: Principal Investigator: Doreen Görß, MD, Rostock University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Assistive technology; Dementia; Smartwatch; Usability; User-centered design
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Cognition Disorders; Language Disorders; Communication Disorders; Intracranial Arterial Diseases; Speech Disorders; Frontotemporal Lobar Degeneration; Intracranial Arteriosclerosis; Leukoencephalopathies; Aphasia; Dementia; Alzheimer Disease; Cognitive Dysfunction; Lewy Body Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Dementia, Vascular
• Other Study ID Numbers: A 2020-0071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No