- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06401915
Intelligent Assistive Technologies for Dementia
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tainan, Taiwan
- National Cheng Kung University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Caregiver
- Principal caregivers of PwD(people with dementia) or organizer or manager of care organization
Care Recipient
- Aged ≥ 65
- Global Deterioration Scale(GDS):2-4 level
- Healthy adult (no skeletal muscle, neurological,eye and hearing disease)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Platform tester
Participants in this group tested the proposed platform over 6 months, and their feedback were collected 8 times.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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EQ-5D-5L
Time Frame: 5 minutes
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The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.
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5 minutes
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Zarit Burden Interview
Time Frame: 5 minutes
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The Zarit Caregiver Burden Interview (ZBI) was created by Zarit et al. in 1980 [21].
It is a self-administered instrument composed of 22 items scored on a Likert-type scale with 5 response options: never (0 points), rarely (1 point), sometimes (2 points), quite often (3 points), and almost always (4 points).
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5 minutes
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The General Anxiety Disorder 7(GAD-7)
Time Frame: 5 minutes
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GAD-7 items reflect the DSM-IV criteria for GAD.
Respondents are asked to rate each item for frequency of occurrence using a 4-point Likert scale (Not at all = 0, Several days = 1, More than half the days = 2, and Nearly every day = 3).
All responses are summed to calculate the total GAD-7 score.
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5 minutes
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System Usability Scale
Time Frame: 5 minutes
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Created by John Brooke in 1986, the System Usability Scale (SUS) is a widely used tool for evaluating the usability of software, websites, and other interactive systems. Since then, it has become a standard method for assessing the overall user-friendliness of a product.The System Usability Scale is a Likert Scale which includes 10 questions which users of your website will answer. Participants will rank each question from 1 to 5 based on how much they agree with the statement they are reading. 5 means they agree completely, 1 means they disagree vehemently.The average System Usability Scale score is 68. If your score is under 68, then there are probably serious problems with your website usability which you should address. If your score is above 68, then you can relax a little bit. |
5 minutes
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Collaborators and Investigators
Investigators
- Principal Investigator: Fong-Chin Su, Chair Professor
Publications and helpful links
General Publications
- Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Sun Y, Lee HJ, Yang SC, Chen TF, Lin KN, Lin CC, Wang PN, Tang LY, Chiu MJ. A nationwide survey of mild cognitive impairment and dementia, including very mild dementia, in Taiwan. PLoS One. 2014 Jun 18;9(6):e100303. doi: 10.1371/journal.pone.0100303. eCollection 2014.
- Vitaliano PP, Zhang J, Scanlan JM. Is caregiving hazardous to one's physical health? A meta-analysis. Psychol Bull. 2003 Nov;129(6):946-72. doi: 10.1037/0033-2909.129.6.946.
- Devlin NJ, Krabbe PF. The development of new research methods for the valuation of EQ-5D-5L. Eur J Health Econ. 2013 Jul;14 Suppl 1(Suppl 1):S1-3. doi: 10.1007/s10198-013-0502-3. No abstract available.
- Reisberg B, Ferris SH, de Leon MJ, Crook T. The Global Deterioration Scale for assessment of primary degenerative dementia. Am J Psychiatry. 1982 Sep;139(9):1136-9. doi: 10.1176/ajp.139.9.1136.
- Ko KT, Yip PK, Liu SI, Huang CR. Chinese version of the Zarit caregiver Burden Interview: a validation study. Am J Geriatr Psychiatry. 2008 Jun;16(6):513-8. doi: 10.1097/JGP.0b013e318167ae5b.
- Cahill S. WHO's global action plan on the public health response to dementia: some challenges and opportunities. Aging Ment Health. 2020 Feb;24(2):197-199. doi: 10.1080/13607863.2018.1544213. Epub 2019 Jan 2.
- Prince M, et al., World Alzheimer Report 2015: The Global Impact of Dementia. 2015: Alzheimer's Disease International.
- Yeh, M.-J., Long-term care system in Taiwan: the 2017 major reform and its challenges. Ageing and Society, 2019. 40(6): p. 1334-1351.
- Commission, E.E., Long-Term Care in Ageing Societies-Challenges and Policy Options. 2013, Brussels: European Commission.
- Progression, A.s.P.s. Global Dementia Scale. 2021.
- Brooke, J., SUS-A quick and dirty usability scale. Usability evaluation in industry, 1996. 189(194): p. 4-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-ER-112-026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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