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

Alzheimer Disease Clinical Trial

— SAIN_UMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05885620
• Other study ID #: A 2020-0071
• Status: Completed
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: November 10, 2022

Study information

• Verified date: June 2023
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Cognitive Dysfunction
• Dementia
• Dementia Frontotemporal
• Dementia With Lewy Bodies
• Dementia, Mixed
• Dementia, Vascular
• Frontotemporal Dementia
• Lewy Body Disease
• Mild Cognitive Impairment
• Pick Disease of the Brain

Intervention

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

Locations

Country	Name	City	State
Germany	Rostock University Medical Center	Rostock

Sponsors (3)

Lead Sponsor	Collaborator
University of Rostock	Fraunhofer Institute, German Center for Neurodegenerative Diseases (DZNE)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User Experience	Assessment of overall user experience with questionnaire. Qualitative Data.	directly after intervention
Primary	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	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
Secondary	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
Secondary	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
Secondary	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