- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01965639
Southeastern Diabetes Initiative Clinical Intervention (SEDI)
A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Clinical care will be delivered by a multidisciplinary team including (but not limited to) an physician, nurse practitioner, dietician, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker. Care will be delivered in community settings including home visits and community based clinics. With the exception of specific surveys (listed in the Study Intervention section) all data are being collected for the purpose of delivery of standard preventive care and clinical care. The population group will include patients diagnosed with Type 2 Diabetes Mellitus in four Southern United States counties, meeting certain inclusion criteria, and deemed "high risk" as determined by a set of standard criteria or a risk algorithm run on secondary data.
The investigators plan to characterize patients diagnosed or at risk for diabetes mellitus, and allow more detailed knowledge of their health than is provided by standard public health data. The investigators will use descriptive, parametric and non-parametric statistics to describe baseline characteristics (demographics and clinical measures of disease severity) of the sample and will compare responders and dropouts on independent and dependent variables, report any significant differences, and include this in the interpretation of results.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Mississippi
-
Madison, Mississippi, Forente stater
- Mississippi Public Health Institute
-
-
North Carolina
-
Durham, North Carolina, Forente stater
- Durham County Department of Public Health
-
Kannapolis, North Carolina, Forente stater
- Cabarrus Health Alliance
-
-
West Virginia
-
Williamson, West Virginia, Forente stater
- Williamson Health and Wellness Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adults >=18yrs
- Diagnosis of Type 2 diabetes
- Reside in Durham County, NC, Cabarrus County, NC, Quitman County, MS or Mingo County, WV or the neighboring areas and receive the majority of their healthcare in the four listed counties.
- Have capacity to give consent (or have a surrogate legally authorized representative or caregiver provide consent on their behalf).
- Defined as high risk by the risk algorithm or their primary care clinician.
- Referral from the primary care clinician or patient's medical home if one has been designated.
Exclusion Criteria:
- Lack capacity to make decisions and do not have a surrogate with authority to make health care decisions.
- Have a terminal illness with a life expectancy of 6 months or less
- Diagnosis of Type 1 diabetes or gestational diabetes
- Currently pregnant (confirmed via self-report and/or medical record)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: High Risk group
Extension of Care
|
Clinical care will be delivered by a multidisciplinary team including (but not limited to) a physician, nurse practitioner, dietitian, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker in community settings including home visits and community based clinics.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Mortality
Tidsramme: Up to 24 months
|
Up to 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Rate of health services utilization
Tidsramme: up to 24 months
|
As measured by inpatient hospital admissions and emergency department visits
|
up to 24 months
|
Change in Medication Adherence
Tidsramme: Baseline, 6, 12, 18, and 24 months
|
As measured by the Morisky Medication Adherence Score
|
Baseline, 6, 12, 18, and 24 months
|
Change in HbA1c
Tidsramme: Baseline, 6, 12, 18, and 24 months
|
Baseline, 6, 12, 18, and 24 months
|
|
Change in blood lipids
Tidsramme: Baseline, 6, 12, 18, and 24 months
|
Measurements include total cholesterol, HDL, LDL, triglycerides
|
Baseline, 6, 12, 18, and 24 months
|
Change in blood glucose
Tidsramme: Baseline, 6, 12, 18, and 24 months
|
Baseline, 6, 12, 18, and 24 months
|
|
Change in blood pressure
Tidsramme: Baseline, 6, 12, 18, and 24 months
|
Baseline, 6, 12, 18, and 24 months
|
|
Incidence of micro- and macro-vascular complications
Tidsramme: Up to 24 months
|
Includes retinopathy, neuropathy, kidney disease, cardiovascular disease
|
Up to 24 months
|
Change in patient-reported outcomes
Tidsramme: Baseline, 6, 12, 18, and 24 months
|
Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys
|
Baseline, 6, 12, 18, and 24 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Robert Califf, MD, Duke Translational Medicine Institute
- Hovedetterforsker: Bryan Batch, MD, Duke University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00043463
- 1C1CMS331018 (Annet stipend/finansieringsnummer: Centers for Medicare and Medicaid Services)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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