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Clinical Trials/NCT01461681
NCT01461681
Completed
Not Applicable

A Randomized Controlled Trial for Patients With Heart Failure

University of California, San Francisco2 sites in 1 country30 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of California, San Francisco
Enrollment
30
Locations
2
Primary Endpoint
Assess change in depression using the Center for Epidemiologic Studies Depression Scale (CES-D)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Heart failure (HF) affects more than 5 million Americans and is a major source of morbidity and mortality. Despite optimal management, over half of patients with HF suffer from pain, dyspnea, fatigue, and depression that diminish quality of life (QoL). HF care also exacts a huge financial toll with yearly costs of $35 billion. Although consensus guidelines call for providing palliative care (PC) to patients with HF to relieve suffering and improve QoL, few receive it. The overall aim of this project is to conduct a randomized controlled trial (RCT) to determine if an interdisciplinary PC intervention (Symptom Management Service-HF [SMS-HF]) provided concurrently with standard cardiology care improves symptoms, QoL and satisfaction, and reduces resource utilization in outpatients with Class II-IV HF compared to standard cardiology care alone. Subjects assigned to the SMS-HF group will receive a 6-month interdisciplinary PC intervention based on the investigators successful SMS model of outpatient PC for oncology patients and focused on assessment and management of physical, emotional, social, and spiritual distress and discussion of treatment preferences. Innovations of this study are that it will rigorously assess the impact of the SMS-HF on patient outcomes and on resource utilization, a key component to ensuring program sustainability. The investigators research team of PC and HF experts is recognized for its PC research and has a proven record of collaborating, conducting RCTs of PC interventions, and studying outpatients with HF. The environment at UCSF is highly supportive of innovative research and of sustaining programs with demonstrated improvements in patient outcomes and operational effectiveness. The overall goal is to use the results from this study to support an application to the NIH for a multi-center RCT of the SMS-HF and to study similar models of concurrent PC for patients with other serious illnesses.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
December 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Non-English speaking
  • Previous consult by Palliative Care Service
  • Pulmonary HTN
  • Right Heart Failure
  • PCI or CABG patient within this admission
  • AS with planned surgical intervention
  • Pre/post heart transplant
  • Pre/post organ transplant within this admission
  • Dementia (unable to consent)
  • Active drug user

Outcomes

Primary Outcomes

Assess change in depression using the Center for Epidemiologic Studies Depression Scale (CES-D)

Time Frame: Outcome measures will be assessed through month 6 post baseline

Outcome measures will be assessed at baseline, 3-months and 6-months The CES-D is a 20-item measure that includes items pertaining to a range of depressive symptoms. Each symptom is assessed 'in the past week' and recorded on a 4-point numeric scale (0= "rarely or none of the time" to 3= "most or all of the time") providing a composite score (range 0 - 60). A score of 16 or higher is generally used to denote the presence of significant depressive symptoms.

Study Sites (2)

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