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

Chronic Heart Failure Clinical Trial

— CASA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739686
• Other study ID #: 5R01NR013422-02
• Secondary ID: 11-0969
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: July 28, 2017
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2017
• Source: Denver Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Denver Health	Denver	Colorado
United States	VA Eastern Colorado Health Care System(ECHCS)	Denver	Colorado

Sponsors (5)

Lead Sponsor	Collaborator
Denver Research Institute	Denver Health Medical Center, University of Colorado, Denver, University of Iowa, VA Eastern Colorado Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score	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.	6 months
Secondary	Difference in Patient Health Questionnaire-9 (PHQ-9) score	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.	6 months
Secondary	Difference in symptom distress, measured using the General Symptom Distress Scale	The General Symptom Distress Scale (GSDS)includes a measure of overall symptom distress and ability to manage symptoms.	6 months
Secondary	Difference in Self-care of Heart Failure Index (SCHFI)	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	12 months
Secondary	Difference in Satisfaction with Healthcare		6 months
Secondary	Difference in pain using the PEG	The PEG items assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G).	6 months
Secondary	Change in fatigue using the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue measure		6 months
Secondary	Change in Dyspnea	PEG pain measure modified to assess breathlessness	6 months
Secondary	Change in Sheehan Disability Scale	Measure of functioning	12 months
Secondary	Change in Quality of Life at the End of Life (QUAL-E)	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.	12 months