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Effective Care Management of Depressed Diabetes Patients (The Positive Steps Study)

24. april 2015 opdateret af: John Piette, University of Michigan

Effective Care Management of Depressed Diabetes Patients

Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.

Studieoversigt

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

Interventionel

Tilmelding (Faktiske)

339

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Health System
      • Ann Arbor, Michigan, Forenede Stater, 48105
        • VA Ann Arbor Healthcare System
      • Grand Blanc, Michigan, Forenede Stater, 48439
        • Genesys Regional Medical Center

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

21 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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.

  • Report screening results
  • Notify PCP of screening results (optional per patient)
  • PCP referrals
  • Educational materials regarding diabetes, physical activity, and depression
Eksperimentel: Staged Care Management
Adult patients with diabetes and depression
  • Basic physical activity counseling
  • Notify PCP and facilitate initiation of antidepressants
  • Medication monitoring calls at 1, 2, 4, 6, 8, 10, and 12 weeks*
  • 1/mo monitoring in continuation phase (mos. 4-12)*
  • Report & recommendations to PCP after each patient call
  • Note: *average of 10 minutes of telephone time each (series is repeated if second antidepressant trial is needed)
  • Notify PCP
  • CBT Manual
  • Weekly CBT focused counseling for 12 weeks**
  • Monthly CBT in months 4-12**
  • Behavioral physical activity counseling
  • Report & recommendations to PCP after each patient call
  • Note: **average of 50 minutes of telephone time each

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: John D Piette, PhD, VA Ann Arbor Healthcare System

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. maj 2005

Primær færdiggørelse (Faktiske)

1. oktober 2009

Studieafslutning (Faktiske)

1. april 2011

Datoer for studieregistrering

Først indsendt

15. april 2010

Først indsendt, der opfyldte QC-kriterier

16. april 2010

Først opslået (Skøn)

20. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

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 .

Kliniske forsøg med Depression

Kliniske forsøg med Medication Care Management (MCM)

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