Major Depressive Disorder (MDD)
8. august 2012 opdateret af: Eli Lilly and Company
Effectiveness of Physicians' Education, Implementation and Follow up of Current Recommendations Regarding Screening for Major Depressive Disorder in High Risk Patients on Improving the Under-Recognition Rates of Depression in Primary Care
The purpose of this study is to assess the effectiveness of systematic screening for depression in high-risk patient participants in everyday clinical practice.
Systematic screening for depression in high-risk patients is recommended to be included as a usual practice but its effectiveness in this context remains controversial.
In this study, 35 primary care physicians (PCPs) in Spain were assigned to intervention (receive one day training in depression screening guidelines and use guidelines for six months) and 34 PCPs were assigned to a control group (manage depression in the usual way for six months).
There were a total of 525 patient participants with MDD.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
525
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Madrid, Spanien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Primary Care Physicians are given the intervention of education to utilize on screened and consented patient participants under the PCP care.
Beskrivelse
Inclusion Criteria:
- PCP Participants: PCPs informed of the study design and who agreed to be randomized to the intervention or control group
- Patient Participants: Aged 18 years or older who provide a written consent for the collection and use of their clinical data
Exclusion Criteria:
- PCP Participants: If they already follow the recommendations on screening or were planning to do so. If they will be absent from their practice for a significant period during the study, or if they do not usually manage depression
- PCP Participants: Those who were not able to understand the aims of the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Intervention
Intervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months
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PCP receives one day training in depression screening guidelines and uses guidelines for six months
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Control
Control group PCP manages depression in the usual way for six months
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PCP manages depression in the usual way for six months
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks
Tidsramme: 24 Weeks
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24 Weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks
Tidsramme: 24 Weeks
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24 Weeks
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Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks
Tidsramme: Baseline, 24 Weeks
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Baseline, 24 Weeks
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Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks
Tidsramme: Baseline, 24 Weeks
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Baseline, 24 Weeks
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Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks
Tidsramme: Baseline, 24 Weeks
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Baseline, 24 Weeks
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Mean Duration of Depressive Episodes in Patient Participants
Tidsramme: 24 Weeks
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24 Weeks
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Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants
Tidsramme: 24 Weeks
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24 Weeks
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Sheehan Disability Scale (SDS) Score in Patient Participants
Tidsramme: 24 Weeks
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24 Weeks
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Mean Duration of Sick Leave Due to Depression in Patient Participants
Tidsramme: 24 Weeks
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24 Weeks
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Percentage of Patient Participants with Sick Leave Due to Depression
Tidsramme: 24 Weeks
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24 Weeks
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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 2009
Primær færdiggørelse (Faktiske)
1. juli 2010
Studieafslutning (Faktiske)
1. juli 2010
Datoer for studieregistrering
Først indsendt
27. juli 2012
Først indsendt, der opfyldte QC-kriterier
8. august 2012
Først opslået (Skøn)
10. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. august 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. august 2012
Sidst verificeret
1. august 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13487
- H6U-XM-S007 (Anden identifikator: Eli Lilly and Company)
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 .