Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Depression and Pain, sponsored by University of California, San Francisco.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-12 |
| Phase | NA |
What the finished NCT01461681 record still lists
NCT01461681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01461681's enrollment target sits among peer trials
30 557th of 679 higher than 105 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Reaching Out to Distressed Medical Residents, Fellows and Faculty
RECRUITING · NA
-
IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)
RECRUITING · NA
-
Cold and Heat Investigation to Lower Levels of Depression
RECRUITING · NA
-
Dosing rTMS for Depression Post-SCI
RECRUITING · NA
-
Exploring Virtual Reality Adventure Training Exergaming
RECRUITING · NA
-
Brief Interventions for Coping with Distress
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia