- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01106885
Effective Care Management of Depressed Diabetes Patients (The Positive Steps Study)
Effective Care Management of Depressed Diabetes Patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Research Plan: 382 patients ages 21-80, including 177 women, and 123 Blacks from the Ann Arbor VA HCS, UM, and the Genesys Health Care System in Flint. Patients will be randomized to: (1) brief education about depression, diabetes self-care, and physical activity; or (2) telephone care management including antidepressant medication care management (MCM) and/or cognitive behavioral therapy (CBT). The MCM module uses a standard algorithm to identify efficacious antidepressants and promote adherence. The CBT module addresses symptoms, exercise, and communication skills.
Methods: Surveys: Patients will complete clinic-based surveys at baseline and 12-months to measure their health status, self-care, provider-patient communication, and resource use. At 4 months, they will complete a mailed questionnaire to capture short-term changes in depressive symptoms, walking, patient-provider communication, medication adherence, and quality-of-life. Physiologic Measures: At baseline and 12-months, patients' A1c and cholesterol will be measured via a fingerstick blood test. We also will measure blood pressure, height, and weight. With patients' 4-month mailed surveys, they will complete fingerstick A1c tests and return the results via mail. The blood tests are identical to those diabetes patients use to self-monitor their blood glucose. Pedometers: We will measure distance walked at baseline, 4 months, and 12 months using a pedometer. Patients will record their walk distances for one week and return the results via mail. Electronic data: Utilization and billing databases will be used to identify health service utilization (ER visits, outpatient care, hospitalizations) occurring during patients' participation and the prior 12 months. Physician feedback. At patients' 12-month assessment, the physician will complete a brief survey about the patient's communication style. All patients will provide written consent administered prior to their face-to-face screening and baseline interviews. Physician 12-month surveys about patients' communication style will be anonymous.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Health System
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Ann Arbor, Michigan, Forenede Stater, 48105
- VA Ann Arbor Healthcare System
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Grand Blanc, Michigan, Forenede Stater, 48439
- Genesys Regional 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. Patients must meet all of the following criteria:
- Active Diabetes (Type 1 & 2)
- Diagnosis of depression
- Using hypoglycemic medications
- At least 1 outpatient visit in last 12 months
- At least 21 years old
Exclusion Criteria. Patients who have any of the following will be excluded:
- Limited life expectancy (heart failure/ on oxygen/ advanced stage cancer/ dialysis)
- End stage renal disease
- Lung cancer
- Dementia
- Bipolar
- Schizophrenia
- Can't speak English
- Memory problems
- Alcohol problems
- Illegal drug use
- Minimal depressive symptoms
- Blood pressure 180/110 or higher
- Problems with loss of consciousness
- Can't walk 10 minutes on level surface
- Not planning to get their care at study site
- PCP not affiliated with study site
- Are not on a stable regimen (change in depression Rx in last 28-30 days)
- Type 1 diabetic if diagnosed before age 15
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Enhanced Usual Care
Adult patients with diabetes and depression.
|
|
Eksperimentel: Staged Care Management
Adult patients with diabetes and depression
|
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Participant HbA1c levels
Tidsramme: one year
|
one year
|
Participant cardiovascular risk index
Tidsramme: one year
|
one year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Sundhedsrelateret livskvalitet
Tidsramme: et år
|
et år
|
|
Proximal intervention targets
Tidsramme: one year
|
(e.g., depressive symptoms, physical activity levels, and provider-patient communication)
|
one year
|
Other self-care behaviors
Tidsramme: one year
|
one year
|
|
Treatment satisfaction
Tidsramme: one year
|
one year
|
|
Resource use
Tidsramme: one year
|
one year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: John D Piette, PhD, VA Ann Arbor Healthcare System
Publikationer og nyttige links
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R18DK066166-01A1 (U.S. NIH-bevilling/kontrakt)
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