NCT02893800

Brief Summary

The project aims to make new technologies for locating people with dementia easier to use for the patients and those caring for them. Objective: To systematically understand what improves the user experience of persons with dementia (PwD) and their primary caregivers (CG) with locating system watches to ultimately allow users to obtain more benefits from using these watches. Aim: Improving the user experience of PwD and CG with locating system watches using a cross-over design and a theory-based educational session approach.

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 Jun 2016

Shorter than P25 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

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

August 29, 2016

Last Update Submit

June 1, 2022

Conditions

Dementia

Keywords

assistive technologydementia caretracking technologylocating systemsuser experience

Outcome Measures

Primary Outcomes (1)

  • Usability

    ISONORM 9241/10 questionnaire (Prümper, 1997)

    8 weeks

Secondary Outcomes (4)

  • Caregiver burden

    8 weeks

  • Acceptance and Practicability

    8 weeks

  • Subjective quality of life

    8 weeks

  • Activities of Daily Living

    8 weeks

Study Arms (2)

Himatic locating system

OTHER

Locating system watch with GPS-technology (free available) Main functions: telephone function and location upon request via smartphone

Device: Locating system watch with GPS-technology

ReSOS locating system

OTHER

Locating system watch with GPS-technology (free available) Main functions: telephone function and location upon request via smartphone

Device: Locating system watch with GPS-technology

Interventions

Locating system watch with GPS-technologyDEVICE

Patients using locating system watches with embedded global positioning system (GPS) technology and telephone function; Caregivers using a Smartphone with an installed application to see the current location of the patient and with the possibility to call the patient

Himatic locating systemReSOS locating system

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of all kinds of dementia or mild cognitive impairment

You may not qualify if:

  • not able to move outside alone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Medicine

Berlin, Germany

Location

Related Publications (1)

  • Megges H, Freiesleben SD, Rosch C, Knoll N, Wessel L, Peters O. User experience and clinical effectiveness with two wearable global positioning system devices in home dementia care. Alzheimers Dement (N Y). 2018 Nov 9;4:636-644. doi: 10.1016/j.trci.2018.10.002. eCollection 2018.

    PMID: 30519629RESULT

Related Links

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Oliver Peters, MD

    Charité CBF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 9, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 6, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

Aim: develop better business model designs to promote the adoption of assistive technologies in the field of dementia. In this context we share the qualitative data (transcripts of the interviews) with the department of business administration Prof.Dr.Wessel (Research Group "Health-IT and Business Model Innovation") of the Free University of Berlin.

Locations

DE(1)