SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia (SAIN_UMR)
Primary Purpose
Dementia, Mild Cognitive Impairment, Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
drinking reminder and cognitive task (smartwatch-based application)
Sponsored by
About this trial
This is an interventional other trial for Dementia focused on measuring Assistive technology, User-centered design, Usability, Smartwatch, Dementia
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
Sites / Locations
- Rostock University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
regular
intense
Arm Description
components of interventions: short vibration and short audio signal, textual greeting, textual prompt, picture short vibration
components of interventions: long vibration and long audio signal, textual greeting, textual prompt and speech output, animation long vibration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05885620
First Posted
May 9, 2023
Last Updated
June 5, 2023
Sponsor
University of Rostock
Collaborators
German Center for Neurodegenerative Diseases (DZNE), Fraunhofer Institute
1. Study Identification
Unique Protocol Identification Number
NCT05885620
Brief Title
SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia
Acronym
SAIN_UMR
Official Title
Sensor-based Individualized Activity Management System for People With Dementia: Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rostock
Collaborators
German Center for Neurodegenerative Diseases (DZNE), Fraunhofer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Mild Cognitive Impairment, Alzheimer Disease, Dementia With Lewy Bodies, Dementia, Vascular, Dementia, Mixed, Dementia Frontotemporal
Keywords
Assistive technology, User-centered design, Usability, Smartwatch, Dementia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
regular
Arm Type
Active Comparator
Arm Description
components of interventions:
short vibration and short audio signal,
textual greeting,
textual prompt,
picture
short vibration
Arm Title
intense
Arm Type
Active Comparator
Arm Description
components of interventions:
long vibration and long audio signal,
textual greeting,
textual prompt and speech output,
animation
long vibration
Intervention Type
Device
Intervention Name(s)
drinking reminder and cognitive task (smartwatch-based application)
Intervention Description
task A: prompt to drink some water task B: prompt to circle bells on a sheet
Primary Outcome Measure Information:
Title
Success
Description
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.
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
Usability
Description
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.
Time Frame
directly after intervention
Title
Design
Description
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.
Time Frame
directly after intervention
Title
Usefulness
Description
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.
Time Frame
directly after intervention
Title
Concerns
Description
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.
Time Frame
directly after intervention
Other Pre-specified Outcome Measures:
Title
User Experience
Description
Assessment of overall user experience with questionnaire. Qualitative Data.
Time Frame
directly after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doreen Görß, MD
Organizational Affiliation
Rostock University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rostock University Medical Center
City
Rostock
ZIP/Postal Code
18057
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia
We'll reach out to this number within 24 hrs