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Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care (VODINO)

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Locating system watch with GPS-technology
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring assistive technology, dementia care, tracking technology, locating systems, user experience

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of all kinds of dementia or mild cognitive impairment

Exclusion Criteria:

  • not able to move outside alone

Sites / Locations

  • Charité University Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Himatic locating system

ReSOS locating system

Arm Description

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

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

Outcomes

Primary Outcome Measures

Usability
ISONORM 9241/10 questionnaire (Prümper, 1997)

Secondary Outcome Measures

Caregiver burden
Zarit Burden Interview (German version: Braun etal., 2010)
Acceptance and Practicability
Five-point likert scales and qualitative interview with open-ended questions
Subjective quality of life
European Health Interview Survey-Quality of Life (German version: Brähler et al., 2007)
Activities of Daily Living
BAYER-ADL (Hindmarch, 1998)

Full Information

First Posted
August 29, 2016
Last Updated
June 1, 2022
Sponsor
Charite University, Berlin, Germany
Collaborators
German Alzheimer Society
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1. Study Identification

Unique Protocol Identification Number
NCT02893800
Brief Title
Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care
Acronym
VODINO
Official Title
Assistive Technology for Dementia: Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care (VODINO)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Alzheimer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
assistive technology, dementia care, tracking technology, locating systems, user experience

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Himatic locating system
Arm Type
Other
Arm Description
Locating system watch with GPS-technology (free available) Main functions: telephone function and location upon request via smartphone
Arm Title
ReSOS locating system
Arm Type
Other
Arm Description
Locating system watch with GPS-technology (free available) Main functions: telephone function and location upon request via smartphone
Intervention Type
Device
Intervention Name(s)
Locating system watch with GPS-technology
Intervention Description
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
Primary Outcome Measure Information:
Title
Usability
Description
ISONORM 9241/10 questionnaire (Prümper, 1997)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Caregiver burden
Description
Zarit Burden Interview (German version: Braun etal., 2010)
Time Frame
8 weeks
Title
Acceptance and Practicability
Description
Five-point likert scales and qualitative interview with open-ended questions
Time Frame
8 weeks
Title
Subjective quality of life
Description
European Health Interview Survey-Quality of Life (German version: Brähler et al., 2007)
Time Frame
8 weeks
Title
Activities of Daily Living
Description
BAYER-ADL (Hindmarch, 1998)
Time Frame
8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of all kinds of dementia or mild cognitive impairment Exclusion Criteria: not able to move outside alone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Peters, MD
Organizational Affiliation
Charité CBF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité University Medicine
City
Berlin
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
30519629
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/30519629/
Description
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Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care

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