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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02893800
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : June 6, 2022
Sponsor:
Collaborator:
German Alzheimer Society
Information provided by (Responsible Party):
Oliver Peters, MD, Charite University, Berlin, Germany

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.


Condition or disease Intervention/treatment Phase
Dementia Device: Locating system watch with GPS-technology Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Assistive Technology for Dementia: Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care (VODINO)
Actual Study Start Date : June 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Himatic locating system
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
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

ReSOS locating system
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
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 Measures :
  1. Usability [ Time Frame: 8 weeks ]
    ISONORM 9241/10 questionnaire (Prümper, 1997)


Secondary Outcome Measures :
  1. Caregiver burden [ Time Frame: 8 weeks ]
    Zarit Burden Interview (German version: Braun etal., 2010)

  2. Acceptance and Practicability [ Time Frame: 8 weeks ]
    Five-point likert scales and qualitative interview with open-ended questions

  3. Subjective quality of life [ Time Frame: 8 weeks ]
    European Health Interview Survey-Quality of Life (German version: Brähler et al., 2007)

  4. Activities of Daily Living [ Time Frame: 8 weeks ]
    BAYER-ADL (Hindmarch, 1998)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of all kinds of dementia or mild cognitive impairment

Exclusion Criteria:

  • not able to move outside alone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893800


Locations
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Germany
Charité University Medicine
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
German Alzheimer Society
Investigators
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Principal Investigator: Oliver Peters, MD Charité CBF
Additional Information:
Publications of Results:
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Responsible Party: Oliver Peters, MD, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02893800    
Other Study ID Numbers: VODINO_EA4/033/16
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by Oliver Peters, MD, Charite University, Berlin, Germany:
assistive technology
dementia care
tracking technology
locating systems
user experience
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders