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Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression

1 maja 2014 zaktualizowane przez: Wayne Katon, University of Washington

Randomized Trial of Liaison Psychiatry in Primary Care

This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Depression is a serious medical illness that has been associated with increased risk for heart disease and diabetes. Depression may negatively impact aspects of self-care that are required to effectively manage such long-term diseases. In depressed people who have heart disease and/or diabetes, treatment for depression appears to result in only limited improvements in depression symptoms and no improvements in heart disease and diabetes symptoms. An integrated treatment approach may be more effective in improving all three conditions. This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.

Participants in this single-blind study will be randomly assigned to take part in the case management intervention or receive usual care. All participants will attend 5 in-person study evaluation visits and receive 4 follow-up phone calls over 24 months. At each of the study visits, measurements of height, weight, waist size, and blood pressure will be taken. At study evaluations, blood and urine samples will also be taken. Participants will be asked not to eat for 8 hours before providing blood samples at 3 of the visits. During follow-up phone calls participants will answer various questions.

The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress. Outcomes will be measured at Months 6, 12, 18, and 24 months.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

214

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98101
        • Group Health Cooperative

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Diagnosis of diabetes and/or heart disease
  • Poor disease control (defined as an HbA1c level of at least 8.5%, blood pressure greater than 140/90 mm Hg, LDL cholesterol greater than 130 mg/dL)
  • Diagnosis of major depressive disorder

Exclusion Criteria:

  • History of psychosis
  • At high risk for suicide
  • Cognitive impairment
  • Current alcohol or substance abuse disorder
  • Does not own a telephone
  • Currently seeking psychiatric care
  • Pregnant or breastfeeding
  • Currently enrolled in a Group Health Cooperative disease management program
  • Terminal illness
  • Plans to leave Group Health Cooperative in less than a year
  • Does not speak English

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: B
Treatment as usual
Behawioralne: Treatment as usual
Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care.
Eksperymentalny: A
Case management intervention
Behawioralne: Nurse-led case management
The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c
Ramy czasowe: Baseline to 12 months
A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large.
Baseline to 12 months
Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months
Ramy czasowe: Measured at Baseline, 6 Months, 12 months

SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms.

For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured at Baseline, 6 Months, 12 months
Systolic Blood Pressure at Baseline, 6 Months and 12 Months
Ramy czasowe: Measured at Baseline, 6 Months, 12 months

Systolic Blood Pressure was measured at Baseline, 6 months and 12 months

For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured at Baseline, 6 Months, 12 months
LDL Cholesterol at Baseline and 12 Months
Ramy czasowe: Measured at Baseline and 12 months

LDL Cholesterol was measured at Baseline and 12 months

For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured at Baseline and 12 months
Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months
Ramy czasowe: Measured at Baseline, 6 months and 12 months

Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months

For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured at Baseline, 6 months and 12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Functional Impairment
Ramy czasowe: Measured at Months 6, 12 months
Disability was measured by the Sheehan Disability scale which measures the extent to which health interferes with social, vocational and familial functioning each on a 0 to 10 Likert scale where 0 is "not at all" and 10 is "extremely". This scale consists of 3 items which are averaged together to create the average disability score, which ranges from 0 to 10.
Measured at Months 6, 12 months
Health Care Costs
Ramy czasowe: Cumulative outpatient costs over 24 months
Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs
Cumulative outpatient costs over 24 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Washington

Współpracownicy

National Institute of Mental Health (NIMH)

Śledczy

  • Główny śledczy: Wayne J. Katon, MD, University of Washington

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 maja 2007

Zakończenie podstawowe (Rzeczywisty)

1 października 2010

Ukończenie studiów (Rzeczywisty)

1 sierpnia 2012

Daty rejestracji na studia

Pierwszy przesłany

1 maja 2007

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 maja 2007

Pierwszy wysłany (Oszacować)

3 maja 2007

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

2 maja 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 maja 2014

Ostatnia weryfikacja

1 maja 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • R01MH041739 (Grant/umowa NIH USA)
  • DSIR 82-SEPC

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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