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Healthy AdultNCT06401915

Intelligent Assistive Technologies for Dementia

An observational study of Healthy Adult, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 95 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adult
How many people
18 participants
Where
1 siteTaiwan
Study dates
10 May 2023to 6 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Residents of Tainan city, Taiwan

Who may be able to join

  • 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)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng Kung University

    Tainan

Other trials in Taiwan

About this study

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.

Conditions
Healthy Adult
Keywords
Dementia Care, Hand rehabilitation, HAAL dashboard

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06401915
Study groupRoleWhat they receive
Platform testerParticipants in this group tested the proposed platform over 6 months, and their feedback were collected 8 times.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start10 May 2023
  3. Primary completion6 Nov 2023
  4. Study completion6 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06401915
Sponsor's protocol ID
B-ER-112-026
Status last verified
May 2024
First submitted
2 May 2024
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Adult, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EQ-5D-5L (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06401915, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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