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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893800
Other study ID # VODINO_EA4/033/16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date November 2016

Study information

Verified date June 2022
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This entire research field (assistive technology in dementia care) is based on the need to address care solutions for a growing number of PwD and CG in the absence of a cure for (Alzheimer's) dementia. Methods: A user study with two free available locating watches. In educational sessions PwD obtain a locating watch and their CG a smartphone with the application of the locating watch installed on it. By using a cross-over design each dyad (PwD and CG) obtaining both locating systems. The designed educational session hopefully ease subsequent use and make it more enjoyable. The dyads will use each system over four weeks in their real environment.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - diagnosis of all kinds of dementia or mild cognitive impairment Exclusion Criteria: - not able to move outside alone

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Locating system watch with GPS-technology
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

Locations

Country Name City State
Germany Charité University Medicine Berlin

Sponsors (2)

Lead Sponsor Collaborator
Charite University, Berlin, Germany German Alzheimer Society

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Megges H, Freiesleben SD, Rösch 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.2018.1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Usability ISONORM 9241/10 questionnaire (Prümper, 1997) 8 weeks
Secondary Caregiver burden Zarit Burden Interview (German version: Braun etal., 2010) 8 weeks
Secondary Acceptance and Practicability Five-point likert scales and qualitative interview with open-ended questions 8 weeks
Secondary Subjective quality of life European Health Interview Survey-Quality of Life (German version: Brähler et al., 2007) 8 weeks
Secondary Activities of Daily Living BAYER-ADL (Hindmarch, 1998) 8 weeks
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