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DementiaDMD-DTNCT02036099

Driving in Mild Dementia Decision Tool

A study testing Driving in Mild Dementia Decision Tool in people with Dementia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Based on the literature on dementia and driving, and on knowledge tools available to date including one from our current work, a Driving in Mild Dementia Decision Tool (DMD-DT) will be adapted and tailored to guide physicians in their decisions to report a driver with mild dementia to the provincial licensing agency. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Dementia
What is being tested?
Driving in Mild Dementia Decision Tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteCanada
Study dates
Jan 2014to Jan 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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • family physicians and specialist physicians (geriatricians, geriatric psychiatrists, cognitive neurologists) practicing in Ontario, Canada, who assess and treat patients with mild dementia
  • must speak English and have computer access at the point of delivery of care

Who cannot join

  • family physicians must see at least 10 new patients per year with mild dementia, and specialist physicians must see at least 12 new patients per year with mild dementia
  • participants must not have participated in, attended a continuing medical education (CME) event about, or read about our "Dementia and Driving in Ontario" study (2010-2012)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Based on the literature on dementia and driving, and on knowledge tools available to date including one from our current work, a Driving in Mild Dementia Decision Tool (DMD-DT) will be adapted and tailored to guide physicians in their decisions to report a driver with mild dementia to the provincial licensing agency. The DMD-DT intervention will include a) an algorithm-based computerized clinical decision support system (CCDSS) for facilitating driving assessment and physicians' reporting to provincial transportation authorities, b) an individualized educational package for patients and caregivers about dementia and driving and driving cessation, and c) a modified reporting form to provincial driving regulatory authorities. Months 1 to 6: The DMD-DT will be tailored and adapted to practice with the input of the co-investigators and knowledge-users who represent the perspectives of physicians, patients and their caregivers, as well as transportation authorities. Pilot testing will be done, and input from focus groups of knowledge-users will refine the intervention. Physicians will be recruited to participate in a clinical trial of the DMD-DT. Months 7-18: A parallel-group cluster randomized controlled trial (RCT) will be conducted to compare the effects of the DMD-DT to a legislation reminder on recommendations for reporting to the licensing agency. The effects of the DMD-DT on the doctor-patient relationship will be further explored in focus groups and interviews with physicians. Months 19-24: The knowledge obtained from the study will be used to generalize and sustain use of the intervention beyond Ontario, Canada, and to disseminate the information to knowledge-users. The primary outcome measure is the filing of a report to the Ministry of Transportation of Ontario, indicating that the physician has a concern about the patient's health condition (i.e. mild dementia). The primary outcome of the study is the difference in reporting between the DMD-DT and control arms. Since the current reporting rate is low, approximately 13%, from a public health point of view, the primary outcome expected is that physicians in the DMD-DT group will report more patients with mild dementia than those in the control group.

Read the detailed description

as above

Conditions
Dementia
Being tested
Driving in Mild Dementia Decision Tool
Keywords
Dementia, Automobile driving, Accidents, traffic
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Driving in Mild Dementia Decision ToolOther

Study groups in NCT02036099
Study groupRoleWhat they receive
InterventionExperimentalParticipants in this arm will assess patients using the Driving in Mild Dementia Decision Tool.
Receives: Other: Driving in Mild Dementia Decision Tool
ControlNo interventionParticipants in this arm will assess patients using their usual care strategies.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients reported to the Ontario Ministry of Transportation

    The primary outcome of this study is the number of patients reported to the Ontario Ministry of Transportation by study participants. A "report" indicates that the participant believes his/her patient may be unsafe to continue driving due to mild cognitive impairment or mild dementia. The difference in the number of reports filed between the intervention and control group participants will be assessed.

    Measured: When participants have completed 500 patient assessments (expected to take approximately 12 months)

Secondary outcomes (3)

  1. The number of "false positives", i.e. number of patients reported to the Ontario Ministry of Transportation as potentially being unsafe drivers who are deemed by expert consensus to be safe drivers.

    Although the primary aim of the study from a public health point of view is to increase reporting of patients with mild dementia to transportation authorities who are unsafe to drive according to best-evidence, it is important to ensure that physician reporting does not unfairly punish those who are deemed not to be at significant potential risk. Hence, a secondary outcome measure will examine the number of false positive reports, or the number of patients reported when expert consensus indicates they should NOT be reported.

    Measured: When participants have completed 500 patient assessments (expected to take approximately 12 months)

  2. Number of recommendations given for specialized on-road testing

    International guidelines suggest that when physicians are uncertain about the driving safety of their patients, specialized on-road testing should be strongly considered. Such testing, while expensive, has substantially more face validity than in-office testing. A secondary outcome measure for this study is therefore the number of recommendations made by participants for specialized on-road testing for the patients assessed in the study.

    Measured: When participants have completed 500 patient assessments (expected to take approximately 12 months)

  3. Quality of Doctor-Patient Relationship

    Many physicians avoid discussing issues related to driving with their patients who have mild dementia and their caregivers or family members, because it can have a negative effect on the doctor-patient relationship. The impact of the Driving in Mild Dementia Decision Tool on the doctor-patient relationship will be examined in two ways: first, by comparing responses between intervention and control group participants on four 5-point Likert-type questions following each patient encounter; and second, by analyzing transcripts from focus groups with participants following completion of the trial.

    Measured: When participants have completed 500 patient assessments (expected to take approximately 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02036099
Sponsor's protocol ID
KAL129896
Acronym
DMD-DT
Status last verified
Feb 2021
First submitted
3 Jan 2014
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Rapoport MJ, Zucchero Sarracini C, Kiss A, Lee L, Byszewski A, Seitz DP, Vrkljan B, Molnar F, Herrmann N, Tang-Wai DF, Frank C, Henry B, Pimlott N, Masellis M, Naglie G. Computer-Based Driving in Dementia Decision Tool With Mail Support: Cluster Randomized Controlled Trial. J Med Internet Res. 2018 May 25;20(5):e194. doi: 10.2196/jmir.9126.

    PubMed 29802093

Questions about this trial

What is this clinical trial studying?

A study testing Driving in Mild Dementia Decision Tool in people with Dementia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

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 2 inclusion and 2 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 10 Feb 2021. 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 Canada. 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?

Number of patients reported to the Ontario Ministry of Transportation (time frame: When participants have completed 500 patient assessments (expected to take approximately 12 months)). 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 NCT02036099, 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 10 Feb 2021.

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