- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00787475
Northern Manhattan Diabetes Community Outreach Project (NOCHOP)
The objective of this study is to examine the effectiveness of a community health worker intervention at helping to control diabetes among Latinos with poorly controlled Type 2 diabetes.
Hypothesis: Compared to those in Enhanced usual care group, patients randomized to the intervention will, at 12 months, have greater reductions in: (1) HgA1C; (2) low density lipoprotein (LDL); and (3) systolic and diastolic BP.
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult patients age 35-70 years*
- Receiving care at our clinic (2 visits with a primary care provider in the previous year)
- Living in Northern Manhattan or Western Bronx (based on zip codes)
- Had a hemoglobin A1C-done within the past year, with the latest value being > or = 8.0
Exclusion Criteria:
- Patients whose primary care physician (PCP) believes are not appropriate candidates for participation
- Type 1 diabetics (identified by PCP), as their care is quite distinct from that of Type II patients, and there are very few such patients in our clinic
- Patients with diabetes diagnosed when under age 25 ("new-onset" Type I diabetes) as such patients are extremely rare in our primary care clinics
- Patients who do not self-identify as Hispanic (Hispanics can be of any race e.g. white, black, mixed)
- Any life-threatening or extreme medical co-morbidity, such as an active cancer diagnosis, paraplegia, or end stage cardio-pulmonary disease
- Having a diabetes diagnosis for < 1 year, to ensure the stability of hemoglobin A1C values above 8.0
- Planning to move out of the neighborhood during the next year
- Planning to travel out of the neighborhood for more than three consecutive months
- Enrollment in any other cardiovascular disease (CVD) or diabetes intervention study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
CHW intervention
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Community Health workers with at least 4 home visits, 8 phone calls, and 10 group visits.
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Ingen indgriben: 2
Enhanced usual care (brochure mailings)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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HgA1C level
Tidsramme: Up to 12 months
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Up to 12 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Measurement of LDL
Tidsramme: Up to 12 months
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Up to 12 months
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Measurement of systolic blood pressure
Tidsramme: Up to 12 months
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Up to 12 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Walter Palmas, MD, Columbia University Medical Director
Publikationer og nyttige links
Generelle publikationer
- Palmas W, Findley SE, Mejia M, Batista M, Teresi J, Kong J, Silver S, Fleck EM, Luchsinger JA, Carrasquillo O. Results of the northern Manhattan diabetes community outreach project: a randomized trial studying a community health worker intervention to improve diabetes care in Hispanic adults. Diabetes Care. 2014 Apr;37(4):963-9. doi: 10.2337/dc13-2142. Epub 2014 Feb 4.
- Palmas W, Teresi JA, Findley S, Mejia M, Batista M, Kong J, Silver S, Luchsinger JA, Carrasquillo O. Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults. BMJ Open. 2012 Mar 26;2(2):e001051. doi: 10.1136/bmjopen-2012-001051. Print 2012.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AAAD1689
- MD00206P60 (Andet bevillings-/finansieringsnummer: NIH)
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