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

June 1, 2022 updated by: Oliver Peters, MD, Charite University, Berlin, Germany

Assistive Technology for Dementia: Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care (VODINO)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité University Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of all kinds of dementia or mild cognitive impairment

Exclusion Criteria:

  • not able to move outside alone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability
Time Frame: 8 weeks
ISONORM 9241/10 questionnaire (Prümper, 1997)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver burden
Time Frame: 8 weeks
Zarit Burden Interview (German version: Braun etal., 2010)
8 weeks
Acceptance and Practicability
Time Frame: 8 weeks
Five-point likert scales and qualitative interview with open-ended questions
8 weeks
Subjective quality of life
Time Frame: 8 weeks
European Health Interview Survey-Quality of Life (German version: Brähler et al., 2007)
8 weeks
Activities of Daily Living
Time Frame: 8 weeks
BAYER-ADL (Hindmarch, 1998)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Alzheimer Society

Investigators

  • Principal Investigator: Oliver Peters, MD, Charité CBF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VODINO_EA4/033/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on Locating system watch with GPS-technology

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe