NCT05885620

Brief Summary

Assistive Technologies (ATs) can help people living with dementia (PwD) maintain their everyday activity. Still, there is a gap between potential and supply. Involving future users can close the gap. But the value of participation from PwD is unclear. The study examined smartwatch interactions from people with dementia or with mild cognitive impairment. Participants received "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts on a customized smartwatch to perform everyday tasks. Participants' reactions were observed via cameras. Users' feedback was captured with questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

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

November 10, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

May 9, 2023

Last Update Submit

June 5, 2023

Conditions

DementiaMild Cognitive ImpairmentAlzheimer DiseaseDementia With Lewy BodiesDementia, VascularDementia, MixedDementia Frontotemporal

Keywords

Assistive technologyUser-centered designUsabilitySmartwatchDementia

Outcome Measures

Primary Outcomes (1)

  • Success

    Observation of success regarding to researchers' success protocol. Measurement is performed in the following: 1\) Live observation during procedure rated with 0, 0.5 or 1 point: 0 points: Participant shows no activity that could potentially lead to task fulfillment. 0.5 points: Participant intiated actions that result in incomplete task fulfillment. 1 point: Participant completely fullfilled the task (task A: drunk some water tasb B: circled something on the worksheet with the pencil). Only the best performance for each task was rated. Repetitions were not scored. The scores of both tasks were summarized, resulting in success values from 0 to 2 points.

    during procedure

Secondary Outcomes (4)

  • Usability

    directly after intervention

  • Design

    directly after intervention

  • Usefulness

    directly after intervention

  • Concerns

    directly after intervention

Other Outcomes (1)

  • User Experience

    directly after intervention

Study Arms (2)

regular

ACTIVE COMPARATOR

components of interventions: 1. short vibration and short audio signal, 2. textual greeting, 3. textual prompt, 4. picture 5. short vibration

Device: drinking reminder and cognitive task (smartwatch-based application)

intense

ACTIVE COMPARATOR

components of interventions: 1. long vibration and long audio signal, 2. textual greeting, 3. textual prompt and speech output, 4. animation 5. long vibration

Device: drinking reminder and cognitive task (smartwatch-based application)

Interventions

drinking reminder and cognitive task (smartwatch-based application)DEVICE

task A: prompt to drink some water task B: prompt to circle bells on a sheet

intenseregular

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of mild cognitive impairment or dementia
  • Mini Mental Status Examination (MMSE) ≥ 9 and ≤ 28 points

You may not qualify if:

  • clinically relevant impairment of visual acuity and/or hearing
  • relevant speech/language impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rostock University Medical Center

Rostock, 18057, Germany

Location

Related Publications (1)

  • Goerss D, Kohler S, Rong E, Temp AG, Kilimann I, Bieber G, Teipel S. Smartwatch-Based Interventions for People With Dementia: User-Centered Design Approach. JMIR Aging. 2024 Jun 7;7:e50107. doi: 10.2196/50107.

    PMID: 38848116DERIVED

MeSH Terms

Conditions

DementiaCognitive DysfunctionAlzheimer DiseaseLewy Body DiseaseDementia, VascularMixed DementiasPick Disease of the Brain

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersTauopathiesNeurodegenerative DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesFrontotemporal DementiaFrontotemporal Lobar Degeneration

Study Officials

  • Doreen Görß, MD

    Rostock University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 2, 2023

Study Start

November 10, 2020

Primary Completion

November 10, 2022

Study Completion

November 10, 2022

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)