- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02044211
Blended Collaborative Care for Heart Failure and Co-Morbid Depression
Przegląd badań
Status
Szczegółowy opis
Heart failure (HF) is an important public health problem that affects approximately 6.6 million Americans. Despite improvements in cardiac care, it remains the leading cause for hospitalization among Medicare patients and the only major cardiovascular disease whose mortality rate has remained essentially unchanged over the past decade. This failure to improve HF outcomes may be due, in part, to unrecognized and/or inadequately treated depression that is highly prevalent in HF patients. Yet while new HF treatment guidelines advocate routine screening for depression, this recommendation is unlikely to be widely adopted without trial evidence that depression care improves outcomes and efficient methods to provide it.
"Collaborative care" strategies are being increasingly utilized to improve care for HF and other chronic medical conditions, and we recently demonstrated its clinical and cost-effectiveness at treating depression following coronary artery bypass graft surgery. Yet it may be impractical for health care delivery systems to support separate treatment programs for HF and depression. Thus we are encouraged by emerging evidence indicating "blended" collaborative care strategies that target both psychiatric and physical conditions produce greater improvements in mood symptoms and control of cardiovascular risk factors than programs focused solely on depression to propose testing a novel adaptation that could be provided in routine care.
The Specific Aims of this Project are to: (1) evaluate the effectiveness of a telephone-delivered "blended" collaborative care intervention for treating HF and depression that could be adopted into routine clinical practice if proven effective; and (2) advance our understanding of the moderators and mediators of depression treatment on clinical outcomes. We will screen hospitalized patients with systolic HF for depression, and then randomize 625 who screen positive and have at least a moderately elevated level of depressive symptoms at two-weeks following hospital discharge to either: (1) collaborative care for treating both HF and depression ("blended"); (2) collaborative care for treating HF alone (enhanced usual care (eUC)); or (3) their doctors' "usual care" (UC). Additionally, we will enroll 125 non-depressed HF patients to better evaluate the benefits derived from treating depression (total N=750). Our co-primary hypotheses will test whether "blended" collaborative care can produce at 12-months follow-up a: (A) 0.50 effect size (ES) or greater improvement in health-related quality of life (HRQoL) vs. UC; and (B) 0.30 ES or greater improvement in HRQoL vs. eUC. Secondary hypotheses will evaluate the effects of our "blended" intervention on mood, functional status, adherence with guideline-consistent care, incidence of cardiovascular events, health care utilization, and costs.
Improving chronic illness care for medically complex patients is one of the major challenges facing medicine today. We propose to test the effectiveness of an innovative, efficient, scalable, and sustainable intervention that could transform the way HF and other cardiovascular disorders are treated in routine practice.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- University of Pittsburgh
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Systolic heart failure (documented ejection fraction ≤ 40%).
- HF symptoms meeting criteria for New York Heart Association (NYHA) classes II, III or IV.
- Inpatient two-item Patient Health Questionnaire (PHQ-2) screen-positive for depression; or PHQ-2 screen negative for depression and PHQ-9 <5 if non-depressed control.
- PHQ-9 ≥ 10 when reassessed two-weeks following hospital discharge, or PHQ-9 <5 if non-depressed control.
- No cognitive impairment (as documented in the record, use of donepezil or similar medications for treating cognitive impairment, or the Montreal Cognitive Assessment).
- Able to be evaluated and treated for depression as an outpatient.
- English speaking, not illiterate, or possessing any other communication barrier.
- Have a household telephone.
Exclusion Criteria:
- Receiving active treatment for a mood or anxiety disorder from a mental health specialist.
- Unstable medical condition as indicated by history, physical, and/or laboratory findings.
- Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer).
- Organic mood syndromes, including those secondary to medical illness or drugs.
- Active suicidal ideation.
- Current or history of psychotic illness.
- Current or history of bipolar illness according to patient self-report, past medical history, and diagnostic criteria.
- Current alcohol or other substance abuse as evidenced by chart review and the AUDIT-C questionnaire.
- Age ≤ 21 years.
Plan studiów
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 |
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Aktywny komparator: Collaborative Care for Heart Failure + Depression
Collaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone Interventions: Behavioral: Counseling for heart failure self-care Counseling for depression Drug: Pharmacotherapy for heart failure Pharmacotherapy for depression |
Nurse care managers will provide patients with education for their heart failure to facilitate self-management for their condition. In addition, the nurse will telephone the patient to review with their medical history, medications, diet, activity and sleep patterns, and plans for follow-up medical appointments, and offer basic care coordination relative to heart failure care including assistance attaining authorization for home health services in concert with the patient's primary care physician (PCP), and follow-up appointments. After case review with a study internist, the care manager may send treatment recommendations to the patient's physician(s) regarding guideline-indicated care. Afterwards, the care manager will telephone the patient approximately every other week to monitor and promote adherence with recommended care, and suggest adjustments in treatment as applicable following discussion with the clinical team and notification of the patient's PCP and cardiologist.
The care manager will telephone patients randomized to "blended" care patient to review their psychiatric history including use of antidepressant pharmacotherapy, herbal supplements, and alcohol possibly used to self-medicate depressive symptoms; provide basic psychoeducation about depression and its impact on cardiac disease; recommend various self-management strategies (e.g., sufficient rest and exercise); and describe treatment options.
They will include: (1) use of a workbook or computer program to enhance patients' understanding and ability to self-care; (2) initiation or adjustment of antidepressant pharmacotherapy prescribed under their primary care physicians' direction; or (3) referral to a local mental health specialist.
The nurse will then telephone the patient to monitor symptoms and pharmacotherapy use, practice skills imparted through workbook assignments, promote adherence with recommended care, and suggest adjustments in treatment as applicable.
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Aktywny komparator: Collaborative Care for Heart Failure Only
Collaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone Interventions: Behavioral: Counseling for heart failure self-care Usual care for depression Drug: Pharmacotherapy for heart failure Usual Care for depression |
Nurse care managers will provide patients with education for their heart failure to facilitate self-management for their condition. In addition, the nurse will telephone the patient to review with their medical history, medications, diet, activity and sleep patterns, and plans for follow-up medical appointments, and offer basic care coordination relative to heart failure care including assistance attaining authorization for home health services in concert with the patient's primary care physician (PCP), and follow-up appointments. After case review with a study internist, the care manager may send treatment recommendations to the patient's physician(s) regarding guideline-indicated care. Afterwards, the care manager will telephone the patient approximately every other week to monitor and promote adherence with recommended care, and suggest adjustments in treatment as applicable following discussion with the clinical team and notification of the patient's PCP and cardiologist. |
Brak interwencji: Usual Care for Heart Failure and Depression
Control group will receive their doctors' usual care for heart failure and depression
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Brak interwencji: Non-Depressed Comparison Cohort
Control group will receive their doctors' usual care for heart failure
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS)
Ramy czasowe: 12-Months Follow-Up
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Mental Health-Related Quality of Life
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12-Months Follow-Up
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Ramy czasowe: 12-Month Follow-Up
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Disease-Specific Health-Related Quality of Life
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12-Month Follow-Up
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Hamilton Rating Scale for Depression (17-Item)
Ramy czasowe: 12-Months Follow-Up
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Mood symptoms
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12-Months Follow-Up
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Incidence of Rehospitalization
Ramy czasowe: 12-Month Follow-Up
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12-Month Follow-Up
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Mortality
Ramy czasowe: 12-Month Follow-Up
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All-Cause and Cardiovascular Mortality
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12-Month Follow-Up
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Health Care Costs
Ramy czasowe: 12-Month Follow-Up
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Claims data
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12-Month Follow-Up
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Employment
Ramy czasowe: 12-Months Follow-Up
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12-Months Follow-Up
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Bruce L. Rollman, MD, MPH, University of Pittsburgh
Publikacje i pomocne linki
Publikacje ogólne
- Deveney TK, Belnap BH, Mazumdar S, Rollman BL. The prognostic impact and optimal timing of the Patient Health Questionnaire depression screen on 4-year mortality among hospitalized patients with systolic heart failure. Gen Hosp Psychiatry. 2016 Sep-Oct;42:9-14. doi: 10.1016/j.genhosppsych.2016.06.005. Epub 2016 Jun 30.
- Schuster JM, Belnap BH, Roth LH, Rollman BL. The Checklist Manifesto in action: integrating depression treatment into routine cardiac care. Gen Hosp Psychiatry. 2016 May-Jun;40:1-3. doi: 10.1016/j.genhosppsych.2016.01.005. Epub 2016 Jan 22. No abstract available.
- Herbeck Belnap B, Anderson A, Abebe KZ, Ramani R, Muldoon MF, Karp JF, Rollman BL. Blended Collaborative Care to Treat Heart Failure and Comorbid Depression: Rationale and Study Design of the Hopeful Heart Trial. Psychosom Med. 2019 Jul/Aug;81(6):495-505. doi: 10.1097/PSY.0000000000000706.
- Rollman BL. Exercise and Cognitive Training to Improve Neurocognitive Outcomes in Patients With Heart Failure: Can Cardiac Rehabilitation Deliver? Am J Geriatr Psychiatry. 2019 Aug;27(8):820-822. doi: 10.1016/j.jagp.2019.05.001. Epub 2019 May 6. No abstract available.
- Holber JP, Abebe KZ, Huang Y, Jakicic JM, Anderson AM, Belnap BH, Rollman BL. The Relationship Between Objectively Measured Step Count, Clinical Characteristics, and Quality of Life Among Depressed Patients Recently Hospitalized With Systolic Heart Failure. Psychosom Med. 2022 Feb-Mar 01;84(2):231-236. doi: 10.1097/PSY.0000000000001034.
- Rollman BL, Anderson AM, Rothenberger SD, Abebe KZ, Ramani R, Muldoon MF, Jakicic JM, Herbeck Belnap B, Karp JF. Efficacy of Blended Collaborative Care for Patients With Heart Failure and Comorbid Depression: A Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1369-1380. doi: 10.1001/jamainternmed.2021.4978.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- R01HL114016 (Grant/umowa NIH USA)
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 .
Badania kliniczne na Collaborative Care for Heart Failure
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Major Extremity Trauma Research ConsortiumZakończonyCiężki uraz ortopedycznyStany Zjednoczone
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National Taiwan University HospitalRekrutacyjnyNiewydolność sercaTajwan
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VA Office of Research and DevelopmentUS Department of Veterans AffairsZakończonyZaburzenia związane z używaniem substancji | Zdrowie psychiczne | Bezdomność | Połączenie z opiekąStany Zjednoczone
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Christine Kaiser, LAc, DACMRekrutacyjnyProblemy z płodnościąStany Zjednoczone
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University of BirminghamNational Institute for Health Research, United KingdomNieznanyReumatyzm | Choroby zapalne jelit | Przewlekła choroba wątrobyZjednoczone Królestwo
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National Taiwan University HospitalRekrutacyjnyNadciśnienie | Cukrzyca | Masy ciała | Medycyna prewencyjna | Medycyna rodzinnaTajwan
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Dartmouth-Hitchcock Medical CenterJohnson & JohnsonZakończonyZaburzenia depresyjne, majorze | Dystymia | Zaburzenia depresyjne, drobneStany Zjednoczone
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Alcon ResearchZakończonyAstygmatyzm | Krótkowzroczność | Nadwzroczność | AmetropiaStany Zjednoczone