- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00289471
Identifying Patients With Dementia in Primary Care (GEMS)
10. april 2015 oppdatert av: US Department of Veterans Affairs
Dementia in Primary Care: Setting the Stage for Quality Improvement
Veterans who completed GEMS-Phase 1 will be asked to participate in GEMS-Phase 2 to determine the accuracy of methods used to assess mild memory problems. This will better help us evaluate the screening test completed in GEMS-Phase 1. The goals are:
- Compare the assessment of memory made at the initial visit to assessments of memory made at the second evaluation.
- Determine of veterans with mild memory problems have improvement or worsening of these memory problems over time. Our long-term goal remains to optimize the quality of care for veterans with cognitive impairment. We will also determine if patient characteristics can be used to target case-finding, describe the current process of care and evaluate the association between cognitive impairment and overall- and dementia-related health care utilization and costs.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Dementia has high public health significance due to its prevalence, adverse impact on patients and caregivers, high economic cost to society and the rapidly expanding numbers of individuals age 65 and older.
As the largest provider of geriatric care in the U.S., dementia is particularly relevant to the Veterans Health Administration (VHA).
However, only a small proportion of patients with dementia are diagnosed early when treatments are most effective and the opportunity for careful life planning remains, in part because of the absence of feasible, well-validated case-finding instruments.
Our long-term objective is to improve the care and outcomes of veterans with clinically significant cognitive impairment.
The first steps towards realizing this objective are to determine the acceptability of cognitive screening to patients and to identify feasible, valid case-finding tools for primary care.
We will also determine if patient characteristics can be used to target case-finding, describe the current process of care and evaluate the association between cognitive impairment and overall- and dementia-related health care utilization and costs.
Our research team, located in the Center for Health Services Research in Primary Care, brings together researchers uniquely suited to achieving this objective.
Specific Aims1.Primary Aim: To determine if cognitive screening is acceptable to patients, and whether brief cognitive screeners perform as well as the longer Modified Mini-Mental Status Exam (3MS) for dementia and cognitive impairment-not dementia (CIND).Primary Hypothesis 1: Higher perceived risk of dementia, higher perceived benefits and fewer perceived harms from screening will be positively associated with screening acceptance.
Primary Hypotheses 2: Compared to the 3MS, the Mini-Cog, Memory Impairment Screen and 2-item functional screen will have similar performance characteristics.
2.Secondary Aim 1: To determine if sociodemographic and clinical characteristics available in the electronic medical record can be used to target individuals for cognitive screening and improve screening accuracy.
Hypothesis: The combination of sociodemographic characteristics/clinical information and screening results will more accurately discriminate between demented and non-demented patients than screening results alone.3.Secondary Aim 2: To describe current care for an inception cohort with dementia or cognitive impairment-not dementia.
Hypothesis: Compared to patients with dementia, patients with cognitive impairment-not dementia will undergo less diagnostic testing, be less likely to complete an advanced directive and be less likely to receive dementia specific medications.
4.Exploratory Aim: To evaluate the association between cognitive impairment and overall- and dementia-related health care utilization and costs.
Exploratory Hypothesis: Controlling for sociodemographic characteristics and medical comorbidity, overall healthcare utilization and costs will increase as cognitive impairment increases.
In phase 1, a random sample of primary care patients age 65 years will be recruited from 3 primary care clinics to complete the Modified Dementia Screening Acceptance and Perceived Harms Questionnaire.
In phase 2, patients will complete three brief instruments and the standard 15-item 3MS that will be compared to a criterion standard interview for dementia.
We project 140-200 patients will have dementia, 200-300 CIND, and approximately 600 will be cognitively normal.
Instruments will be compared using sensitivity/specificity, likelihood ratios and receiver operating characteristic curves.
The emotional impact of screening will be assessed following screening.
Clinical and sociodemographic characteristics available in the Computerized Patient Record System, together with cognitive screening results, will be analyzed with logistic regression models to identify risk factors that may be used to target individuals for cognitive screening and/or improve screening accuracy.
Care patterns for patients with dementia and CIND will be described based on detailed chart abstractions.
For the exploratory analysis on cognitive impairment and utilization, two-part utilization models will be estimated for each utilization type, outpatient clinic visits, inpatient visits, pharmacy utilization, and other utilization types; utilization data will be obtained from administrative data.
Studietype
Observasjonsmessig
Registrering (Faktiske)
630
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27705
- Durham VA Medical Center HSR&D COE
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Veterans' who have previously completed GEMS-Phase 1 testing, continues to be a VA clinic patient and identifies a key family member or friend who will answer questions about the veteran's memory and daily activities.
Beskrivelse
Inclusion Criteria:
- Previous participant who completed GEMS-Phase 1
- Continues to be a VA clinic patient
- Identifies a key informant with phone
Exclusion Criteria:
- Severe hearing or visual impairment
- Acute medical condition
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Cognitive Screening
Cognitive screening
|
No intervention delivered.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Performance Characteristics
Tidsramme: Cross-sectional [at baseline; no longitudinal component]
|
Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment
|
Cross-sectional [at baseline; no longitudinal component]
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: John W Williams, MD MHS, Durham VA Medical Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Plassman BL, Williams JW Jr, Burke JR, Holsinger T, Benjamin S. Systematic review: factors associated with risk for and possible prevention of cognitive decline in later life. Ann Intern Med. 2010 Aug 3;153(3):182-93. doi: 10.7326/0003-4819-153-3-201008030-00258. Epub 2010 Jun 14.
- Holsinger T, Plassman BL, Stechuchak KM, Burke JR, Coffman CJ, Williams JW Jr. Screening for cognitive impairment: comparing the performance of four instruments in primary care. J Am Geriatr Soc. 2012 Jun;60(6):1027-36. doi: 10.1111/j.1532-5415.2012.03967.x. Epub 2012 May 30.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2009
Primær fullføring (Faktiske)
1. desember 2009
Studiet fullført (Faktiske)
1. oktober 2010
Datoer for studieregistrering
Først innsendt
8. februar 2006
Først innsendt som oppfylte QC-kriteriene
8. februar 2006
Først lagt ut (Anslag)
9. februar 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. mai 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. april 2015
Sist bekreftet
1. april 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIR 05-112
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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