Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Denver Research Institute
Sponsor:
Collaborators:
VA Eastern Colorado Health Care System
University of Colorado, Denver
Denver Health Medical Center
University of Iowa
Information provided by (Responsible Party):
David Bekelman, M.D., Denver Research Institute
ClinicalTrials.gov Identifier:
NCT01739686
First received: November 16, 2012
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

Chronic heart failure is an important public health problem as it is a leading cause of disability, hospitalization, death, and costs. People who live with advanced chronic heart failure suffer from numerous symptoms that affect their daily lives. The investigators are conducting a randomized clinical trial to evaluate a symptom management and psychosocial care intervention to improve health status (symptom burden, functioning, and quality of life). The results will be directly relevant to patients and families who suffer with this illness, as well as to providers, payers, and other researchers.


Condition Intervention
Chronic Heart Failure
Other: CASA Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial

Resource links provided by NLM:


Further study details as provided by Denver Research Institute:

Primary Outcome Measures:
  • Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The KCCQ is a self-administered questionnaire that measures heart failure-specific health status. The KCCQ is reliable, sensitive to clinical change, and predicts hospitalization and mortality. The study will test whether there is a difference in KCCQ overall score between the intervention and control groups at 6 months.


Secondary Outcome Measures:
  • Difference in Patient Health Questionnaire-9 (PHQ-9) score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The PHQ-9 is a 9-item valid and reliable instrument that provides a continuous measure of depressive symptoms and is 88% sensitive and specific for a diagnosis of major depressive disorder. The PHQ-9 was developed in medically-ill outpatients, including patients with heart failure.

  • Difference in symptom distress, measured using the General Symptom Distress Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The General Symptom Distress Scale (GSDS)includes a measure of overall symptom distress and ability to manage symptoms.

  • Difference in Self-care of Heart Failure Index (SCHFI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The SCHFI is a valid and reliable 22-item self-report measure of self-care that includes three self-care scales: maintenance, management, and confidence

  • Difference in Satisfaction with Healthcare [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Difference in pain using the PEG [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The PEG items assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G).

  • Change in fatigue using the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue measure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Dyspnea [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    PEG pain measure modified to assess breathlessness

  • Change in Sheehan Disability Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measure of functioning

  • Change in Quality of Life at the End of Life (QUAL-E) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The QUAL-E is a valid and reliable self-report measure of several domains, each scored separately, of quality of life in advanced illness. We will use the relationship with health care system, preparation, life completion, and global quality of life sub-scales.


Estimated Enrollment: 312
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CASA Intervention

The CASA (Collaborative Care to Alleviate Symptoms and Adjust to Illness) intervention includes 3 components:

  • A nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, pain, and depression.
  • A social worker provides structured counseling targeting adjustment to illness and depression if present.
  • A collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider, cardiologist and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker.

Most of the nurse and social worker visits are by phone.

Other: CASA Intervention

CASA Intervention

The CASA (Collaborative Care to Alleviate Symptoms and Adjust to Illness) intervention includes 3 components:

A nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, pain, and depression.

A social worker provides structured counseling targeting adjustment to illness and depression if present.

A collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider, cardiologist and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker.

Most of the nurse and social worker visits are by phone.

No Intervention: Usual Care
Patients in the control group will continue to receive care at the discretion of their providers, which may include referral to cardiology, palliative care, or mental health. If patients self-report depression on baseline surveys, this information will be given to their provider, and patients will be given resources. Patients will have the same amount of interaction with research assistants as the intervention patients, completing questionnaires and participating in study visits at the same frequency.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years of age or older
  • Able to read and understand English
  • Consistent access to a telephone
  • Patients have a primary care or other provider who is willing to facilitate intervention medical recommendations
  • A diagnosis of heart failure with at least one of the following:

[hospitalization primarily for heart failure in the year prior (including current); taking at least 20 mg oral furosemide (or equivalent) daily in a single or divided dose; Brain natriuretic peptide(BNP) ≥ 100 or N-terminal prohormone of brain natriuretic peptide(NT-proBNP) ≥ 500; EF≤40%]

  • Report a low health status (KCCQ-SF≤70)
  • Bothered by at least one target symptom:

[Pain; Depression; Fatigue; Breathlessness]

Exclusion Criteria:

  • Previous diagnosis of dementia
  • Active substance abuse or dependence, defined by either a diagnosis of abuse or dependence or an AUDIT-C ≥ 8, or self-reported substance abuse in the past 3 months
  • Comorbid metastatic cancer
  • Nursing home resident
  • Heart Transplant recipient
  • LVAD recipient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739686

Contacts
Contact: Kelley Burns, MA 720-857-5093 kelley.burns@va.gov

Locations
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: David Bekelman, MD, MPH    720-857-5098    david.bekelman@ucdenver.edu   
Contact: Kelley Burns, MA    720-857-5093    kelley.burns@ucdenver.edu   
Sub-Investigator: Larry Allen, MD         
Sub-Investigator: Paula Meek, PHD, RN         
VA Eastern Colorado Health Care System(ECHCS) Recruiting
Denver, Colorado, United States, 80220
Contact: David Bekelman, MD, MPH    720-857-5088    david.bekelman@va.gov   
Contact: Kelley Burns, MA    720-857-5093    kelley.burns@va.gov   
Principal Investigator: David Bekelman, MD, MPH         
Sub-Investigator: Connor McBryde, MD         
Sub-Investigator: Brack Hattler, MD         
Sub-Investigator: Robert Burke, MD         
Denver Health Recruiting
Denver, Colorado, United States, 80204
Contact: David Bekelman, MD, MPH    720-857-5098    david.bekelman@va.gov   
Contact: Kelley Burns, MA    720-857-5093    kelley.burns@va.gov   
Sub-Investigator: Ed Havranek, MD         
Sponsors and Collaborators
Denver Research Institute
VA Eastern Colorado Health Care System
University of Colorado, Denver
Denver Health Medical Center
University of Iowa
Investigators
Principal Investigator: David Bekelman, MD, MPH Denver Research Institute
  More Information

No publications provided

Responsible Party: David Bekelman, M.D., Associate Professor of Medicine, Denver Research Institute
ClinicalTrials.gov Identifier: NCT01739686     History of Changes
Other Study ID Numbers: 5R01NR013422-02, 11-0969
Study First Received: November 16, 2012
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Denver Research Institute:
Quality of Life
Symptoms
Palliative care
Symptom management
Disease management
Health delivery

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014