ClinicalTrials.gg
CompletedNCT06401915Updated May 9, 2024

Intelligent Assistive Technologies for Dementia

An observational study in Healthy Adult, sponsored by National Cheng-Kung University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by National Cheng-Kung University Hospital · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
18
Ages
20 Years to 95 Years
Sex
All
01

Study summary

With the HAAL(HeAlthy Ageing eco system for peopLe with dementia) project, the Netherlands, Taiwan, Italy, Austria, and Denmark combine their strength, co-create, evaluate and share their experiences in supporting dementia care by state-of-the-art AAL bundles.Co-design sessions will take place before developing the dashboard, consisting of (in)formal carers, and older people/clients they care for. The HAAL project will conduct field trials with the first version of the dashboard (Alpha testing) and after Alpha testing, a Beta version of the dashboard will be developed according users' feedback. Then more end-users will be incorporated in Beta testing.The aims of the dashboard are to provide support to reduce the workload of the caregivers and allow psychological relief, which eventually support clients' wellbeing.

02

Conditions studied

  • Healthy Adult

Keywords

  • Dementia Care
  • Hand rehabilitation
  • HAAL dashboard
03

In context

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 276 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Residents of Tainan city, Taiwan

Eligibility criteria

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)
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No

Groups and cohorts

  • Platform tester

    Participants in this group tested the proposed platform over 6 months, and their feedback were collected 8 times.

06

What researchers measure

Primary outcomes

  1. EQ-5D-5L

    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.

    Time frame: 5 minutes

  2. Zarit Burden Interview

    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).

    Time frame: 5 minutes

  3. The General Anxiety Disorder 7(GAD-7)

    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.

    Time frame: 5 minutes

  4. System Usability Scale

    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.

    Time frame: 5 minutes

07

Study locations

1 site
  • National Cheng Kung University
    Tainan, Taiwan
08

References and documents

Publications

  • 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. PubMed 30600688 ↗
  • Prince M, et al., World Alzheimer Report 2015: The Global Impact of Dementia. 2015: Alzheimer's Disease International.
  • 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. PubMed 24940604 ↗
  • 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.
  • 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. PubMed 14599289 ↗
  • Commission, E.E., Long-Term Care in Ageing Societies-Challenges and Policy Options. 2013, Brussels: European Commission.
  • 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. PubMed 7114305 ↗
  • Progression, A.s.P.s. Global Dementia Scale. 2021.
  • 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. PubMed 23900659 ↗
  • 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. PubMed 7203086 ↗
  • 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. PubMed 18515696 ↗
  • 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. PubMed 16717171 ↗
  • Brooke, J., SUS-A quick and dirty usability scale. Usability evaluation in industry, 1996. 189(194): p. 4-7.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2023 to primary completion in Nov 2023, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2024
First posted
May 7, 2024
StartActual
May 10, 2023
Primary completionActual
Nov 6, 2023
CompletionActual
Nov 6, 2023
Last update
May 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06401915
Responsible party
Fong Chin Su (Chair Professor, National Cheng-Kung University Hospital) — Principal investigator
First posted
May 7, 2024
Start date
May 10, 2023
Primary completion
Nov 6, 2023
Completion
Nov 6, 2023
Last update
May 9, 2024

Study contacts

Fong-Chin Su
principal investigator · Chair Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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