DementiaVODINONCT02893800
Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care
A study testing Locating system watch with GPS-technology in people with Dementia, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Locating system watch with GPS-technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of all kinds of dementia or mild cognitive impairment
Who cannot join
- not able to move outside alone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Locating system watch with GPS-technology
- Keywords
- assistive technology, dementia care, tracking technology, locating systems, user experience
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Himatic locating system | Other | Locating system watch with GPS-technology (free available) Main functions: telephone function and location upon request via smartphone Receives: 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 Receives: Device: Locating system watch with GPS-technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
ISONORM 9241/10 questionnaire (Prümper, 1997)
Measured: 8 weeks
Secondary outcomes (4)
Caregiver burden
Zarit Burden Interview (German version: Braun etal., 2010)
Measured: 8 weeks
Acceptance and Practicability
Five-point likert scales and qualitative interview with open-ended questions
Measured: 8 weeks
Subjective quality of life
European Health Interview Survey-Quality of Life (German version: Brähler et al., 2007)
Measured: 8 weeks
Activities of Daily Living
BAYER-ADL (Hindmarch, 1998)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Alzheimer Society
- Responsible party
- Principal investigator, Oliver Peters, MD, Charite University, Berlin, Germany
- Investigators
- Oliver Peters, MD, Principal investigator, Charité CBF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893800
- Sponsor's protocol ID
- VODINO_EA4/033/16
- Acronym
- VODINO
- Status last verified
- Jun 2022
- First submitted
- 29 Aug 2016
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 30519629
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistive Technology for Dementia: Validation and Optimization of the Individual Benefits of Locating Systems in Dementia Care (VODINO)
- ClinicalTrials.gov ID
- NCT02893800
- Acronym / sponsor ID
- VODINO / VODINO_EA4/033/16
- Conditions
- Dementia
- Keywords
- assistive technology, dementia care, tracking technology, locating systems, user experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Alzheimer Society
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Himatic locating system | Other | Device: Locating system watch with GPS-technologyLocating system watch with GPS-technology (free available) Main functions: telephone function and location upon request via smartphone |
| ReSOS locating system | Other | Device: Locating system watch with GPS-technologyLocating system watch with GPS-technology (free available) Main functions: telephone function and location upon request via smartphone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of all kinds of dementia or mild cognitive impairment
Key exclusion criteria (1 listed)
- not able to move outside alone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locating system watch with GPS-technologyPatients 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 | Device | Himatic locating system, ReSOS locating system |
Primary outcome
Usability
Time frame: 8 weeks
ISONORM 9241/10 questionnaire (Prümper, 1997)
4 secondary outcomes
Caregiver burden
Time frame: 8 weeks
Acceptance and Practicability
Time frame: 8 weeks
Subjective quality of life
Time frame: 8 weeks
Activities of Daily Living
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Results publication: PubMed 30519629Megges 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Peters, MD principal investigator
Charité CBF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locating system watch with GPS-technology in people with Dementia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.