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NCT01461681 · ClinicalTrials.gov registry record · NA

Improving Care of Patients With Heart Failure

A NA study of Depression and Pain, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
30
Enrollment target
2
Study locations

NCT01461681 is a NA study of Depression and Pain that has completed, run by University of California, San Francisco. The registered enrollment target is 30 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT01461681, a NA study of Depression and Pain, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target
2
Study locations

Study 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.

Interventions

  • PROCEDURE Symptom Management Service for Heart failure

Study Locations (2)

California

  • UCSF Medical Center - San Francisco
  • University of California San Francisco Medical Center - San Francisco

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-03
Est. Completion 2013-12
Phase NA

What the Registry Record Tells You About NCT01461681

The ClinicalTrials.gov registry entry for NCT01461681 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Symptom Management Service for Heart failure is the first listed.

NCT01461681 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01461681 about?

NCT01461681 is a clinical study titled "Improving Care of Patients With Heart Failure". 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 ...

What is the current status of trial NCT01461681?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2012-03. Estimated completion is 2013-12.

What conditions does trial NCT01461681 study?

This clinical trial studies the following conditions: Depression, Pain, Quality of Life, Dyspnea.

What interventions are being tested in trial NCT01461681?

The interventions under investigation include: Symptom Management Service for Heart failure (PROCEDURE).

Who is sponsoring clinical trial NCT01461681?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01461681 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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