Alzheimer Disease Clinical Trial
— SAIN_UMROfficial title:
Sensor-based Individualized Activity Management System for People With Dementia: Intervention Study
Verified date | June 2023 |
Source | University of Rostock |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Rostock University Medical Center | Rostock |
Lead Sponsor | Collaborator |
---|---|
University of Rostock | Fraunhofer Institute, German Center for Neurodegenerative Diseases (DZNE) |
Germany,
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 |
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