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July. 03, 2024 |
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July. 22, 2024 |
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jRCT1040240055 |
Development of a telemedicine system for dementia - An exploratory study of the usefulness of Carebee, a telecommunication tool for people with dementia. |
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Carebee Study |
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Mar. 06, 2024 |
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15 |
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All patients were in their 70s or older; three were male and 12 were female; one patient in her 90s participated in the study. MMSE scores within 6 months of study participation ranged from 13 to 28. The primary caregivers were 6 husbands, 3 wives, 4 daughters, and 2 other relatives. Ten participants were diagnosed with Alzheimer's disease, three with dementia with Lewy bodies or suspected Lewy body dementia, and two with suspected tauopathy in the elderly. |
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Of the 15 participants, 14 were able to complete up to Step 2, and only one participant was able to complete up to Step 1. Dropout was due to family reasons, being away from home at the time of the final evaluation, and was not study-induced dropout. |
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No adverse events occurred. |
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Regarding the primary endpoint, the rate of continued use of the system (usefulness was defined as 11 or more cases continued to use the system after 4 weeks), all 15 cases were judged to be useful with a checklist score of 4 or higher for Stage A. The primary endpoint was the rate of continued use of the system (usefulness was defined as 11 or more cases continued to use the system after 4 weeks). The rate of continued use of the system after 8 weeks, which was set as a secondary endpoint, was 14/15 (93.3%), showing a high rate of continued use, similar to that after 4 weeks. Both the 4-week and 8-week continuation use rates cleared 11 of 15 patients (73.3%), with 100% (p<0.01) at 4 weeks and 93.3% (p<0.01) at 8 weeks. |
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The practical feasibility of the Carebee system with people with dementia, which was the objective of this study, was demonstrated, and it was clear that the system can be used adequately with light assistance. |
No |
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https://jrct.mhlw.go.jp/latest-detail/jRCT1040240055 |
Yukihiko Washimi |
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National Center for Geriatrics and Gerontology |
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7-430 Morioka-cho Obu-shi Aichi, Japan |
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+81-562-46-2311 |
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washimi@ncgg.go.jp |
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Maiko Asa |
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National Center for Geriatrics and Gerontology |
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7-430 Morioka-cho Obu-shi Aichi, Japan |
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+81-562-46-2311 |
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crndinfo@ncgg.go.jp |
Complete |
April. 10, 2023 |
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| June. 12, 2023 | ||
| 15 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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health services research |
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Persons with dementia (the person in question) |
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1) Has severe hearing impairment, dysarthria, or aphasia. |
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| 65age old over | ||
| 95age old not | ||
Both |
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dementia |
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Step 1: A Hubbit employee visits the home of the person with dementia who has a caregiver to install, set up, and explain the Carebee terminal to the person and caregiver. One week after the installation of the device and four weeks after the installation of the device, the attending physician conducts a 10-15 minute remote consultation with the person and caregiver using this system. |
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D003704 |
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Percentage of continued use of the system during the first 4 weeks of intervention. |
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1) Percentage of continued use of the system at 8 weeks after the start of the intervention. |
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| National Center for Geriatrics and Gerontology |
| National Center for Geriatrics and Gerontology | |
| Not applicable |
| Ethics and Conflict of Interest Committee, National Institute for Longevity Sciences | |
| 7-430 Morioka-cho, Obu City, Aichi Prefecture, Aichi | |
+81-562-46-2311 |
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| Approval | |
April. 10, 2023 |
none |