- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02593552
Video Intervention to Enhance the Safety Of Cognitively Impaired Older Drivers
25. maj 2016 opdateret af: Brian Ott, Rhode Island Hospital
This pilot study was done to assess the feasibility and possible efficacy of a video feedback intervention to improve the safety of cognitively impaired older drivers.
Studieoversigt
Detaljeret beskrivelse
The goals of this pilot study were to demonstrate that 1) g-force technology can effectively detect unsafe driving events by older adults, and 2) cognitively impaired older adults can improve their driving safety with an in-car video feedback intervention.
Unsafe driving events were triggered by g-forces leading to capture of a video record that was then transmitted wirelessly to a remote office where the events were analyzed and scored.
During the baseline phase (3 months), there was no feedback.
During the intervention phase (4-6 months), participants received a weekly progress report in the mail along with DVD of recorded unsafe driving events with recommendations.
The research team then contacted the participant and informant weekly to provide additional coaching, and verify that participants reviewed the information and videos.
During the post-intervention monitoring phase (7-9 months), there was no further feedback.
The primary quantitative outcomes were total number of unsafe driving events/1,000 miles and total safety driving score/1,000 miles.
Secondary qualitative outcomes included the types and severity of unsafe driving events that were recorded.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Fase 2
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
68 år til 90 år (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- age 60-90
- English speaking
- currently driving adults with a valid driving license and at least 10 years of driving experience
- neurological examinations judged to be normal for age or consistent with AD
- questionable to mild dementia (CDR 0.5 to 1)
- MMSE < 28
- have an adult family member or other caregiver, age >21 to participate in counseling feedback
Exclusion Criteria:
- ophthalmologic, physical, or neurologic disorders other than dementia that impair their driving abilities
- visual acuity worse than 20/40 in best eye using distance vision measured by wall chart
- homonymous hemianopia or bitemporal hemianopia on confrontation testing
- musculoskeletal disorders causing major physical handicaps such as frozen joints, inadequately healed fractures, and amputations
- history of alcohol or substance abuse by DSM V diagnostic criteria within the past year
- sedating medications that impair level of consciousness or attention
- language impairment that would interfere with the ability to participate in the educational intervention
- previous road test evaluation or opinion of caregiver or health professional that subject is unsafe to drive.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Video camera
DriveCam video event recorder with counseling feedback
|
Video event monitoring device
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of unsafe driving events
Tidsramme: 9 months
|
Scale
|
9 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Severity score of unsafe driving events
Tidsramme: 9 months
|
Scale
|
9 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2011
Primær færdiggørelse (Faktiske)
1. juli 2014
Studieafslutning (Faktiske)
1. juli 2014
Datoer for studieregistrering
Først indsendt
28. oktober 2015
Først indsendt, der opfyldte QC-kriterier
29. oktober 2015
Først opslået (Skøn)
1. november 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. maj 2016
Sidst verificeret
1. maj 2016
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 263758-14
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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