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

Not Applicable

Completed

• Conditions: Chronic Heart Failure
• Interventions: Other: CASA Intervention

• Registration Number: NCT01739686
• Lead Sponsor: Denver Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-12-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.

Primary Outcome Measures

Name	Time	Method
Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score	6 months	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

Name	Time	Method
Difference in pain using the PEG	6 months	The PEG items assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G).
Difference in Patient Health Questionnaire-9 (PHQ-9) score	6 months	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 Satisfaction with Healthcare	6 months
Change in Dyspnea	6 months	PEG pain measure modified to assess breathlessness
Difference in symptom distress, measured using the General Symptom Distress Scale	6 months	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)	12 months	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
Change in Sheehan Disability Scale	12 months	Measure of functioning
Change in Quality of Life at the End of Life (QUAL-E)	12 months	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.
Change in fatigue using the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue measure	6 months

Trial Locations

Locations (3)

VA Eastern Colorado Health Care System(ECHCS); 🇺🇸 Denver, Colorado, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Denver Health; 🇺🇸 Denver, Colorado, United States