- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00237094
Use of Midlevel Providers in Diabetes Management
Studies have demonstrated that intensive disease management of diabetes and its associated risk factors, hypertension and dyslipidemia, can prevent the progression of vascular complications. However, implementation of well defined guidelines for intensive disease management has been suboptimal. Barriers to success occur at multiple levels, including health care systems, health care providers and patients.
In rural regions of the U.S., reduced availability of primary care providers and specialty services, including diabetes education, present additional barriers to effective diabetes care. Use of a nurse practitioner led interdisciplinary team to intensively manage urban and rural diabetic patients, utilizing telehealth technology to provide care to rural areas, will help begin to address these barriers
The long term goal of the project is to develop a practical and sustainable system of intensive diabetes management that will be effective in helping diabetic patients achieve and maintain goals within established treatment guidelines regardless of geographic location.
Specific aims are:
- To determine in both urban and rural areas if a nurse practitioner led team approach to intensive diabetes management and education improves disease-specific outcomes and patient education compared to traditional care (current diabetes management of urban patients).
- To determine if telehealth is an effective and accepted mechanism for delivery of a nurse practitioner led team approach to intensive diabetes management and education in rural areas.
- To determine if a nurse practitioner led intensive disease management team can identify patient risk factors (psychological, financial, and work-related factors) that may be barriers to patient adherence, earlier in the management of urban diabetic patients compared to traditional care.
- To compare volume and type of service utilization of a nurse practitioner led team approach to diabetes management and education to that of traditional care in both urban and rural areas. Disease-specific outcomes will include physiologic variables (HbA1c, blood pressure, lipid levels), measurement and documentation of preventive services (dilated eye exam, monofilament exam, microabumin testing) and patient's knowledge of disease tested by questionnaire.
Results should show improved outcomes and patient knowledge in urban and rural patients receiving intensive disease management compared to traditional care.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Montana
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Billings, Montana, Forenede Stater, 59101
- Deaconess Billings Clinic Center on Aging
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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:
- Definitive diagnosis of Type II diabetes based on ADA diagnostic criteria.
- All persons with diabetes who do not meet ADA goals for glycemic, blood pressure or lipid control.This includes new or previously diagnosed patients.
- Men and women 21 years of age or older.
- Speaks and reads English
- Willing to participate (informed consent)
Exclusion Criteria:
- Type I diabetes
- Diagnosis of dementia or mental retardation.
- Resident of personal care home, assisted living, or long term care facility.
- Significant drug/alcohol abuse in the past 18 months.
- Active malignant process including patients on chemotherapy.
- Steroid induced diabetes or patient on chronic or intermittent steroid therapy (use for more than 2 months out of a year)
- Acute or chronic inflammatory or infectious disease process (chronic osteomyelitis, HIV, tuberculosis, bacterial endocarditis)
- End stage renal or liver disease.
- Pregnancy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Patricia J Coon, MD, Deaconess Billings Clinic
Datoer for undersøgelser
Studer store datoer
Studiestart
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 65787 (completed)
- 1R18DK065787-01A1 (U.S. NIH-bevilling/kontrakt)
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