NCT06401915

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 2, 2024

Last Update Submit

May 7, 2024

Conditions

Keywords

Dementia CareHand rehabilitationHAAL dashboard

Outcome Measures

Primary Outcomes (4)

  • 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.

    5 minutes

  • 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).

    5 minutes

  • 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.

    5 minutes

  • 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.

    5 minutes

Study Arms (1)

Platform tester

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

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of Tainan city, Taiwan

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, Taiwan

Location

Related Publications (13)

  • 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.

    PMID: 30600688BACKGROUND
  • Prince M, et al., World Alzheimer Report 2015: The Global Impact of Dementia. 2015: Alzheimer's Disease International.

    BACKGROUND
  • 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.

    PMID: 24940604BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 14599289BACKGROUND
  • Commission, E.E., Long-Term Care in Ageing Societies-Challenges and Policy Options. 2013, Brussels: European Commission.

    BACKGROUND
  • 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.

    PMID: 7114305BACKGROUND
  • Progression, A.s.P.s. Global Dementia Scale. 2021.

    BACKGROUND
  • 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.

    PMID: 23900659BACKGROUND
  • 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.

    PMID: 7203086BACKGROUND
  • 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.

    PMID: 18515696BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
  • Brooke, J., SUS-A quick and dirty usability scale. Usability evaluation in industry, 1996. 189(194): p. 4-7.

    BACKGROUND

Study Officials

  • Fong-Chin Su

    Chair Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 7, 2024

Study Start

May 10, 2023

Primary Completion

November 6, 2023

Study Completion

November 6, 2023

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations