Overview

This trial is active, not recruiting.

Condition chronic heart failure
Treatment casa intervention
Sponsor Denver Research Institute
Collaborator VA Eastern Colorado Health Care System
Start date August 2012
End date December 2016
Trial size 312 participants
Trial identifier NCT01739686, 11-0969, 5R01NR013422-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
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)
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.

Primary Outcomes

Measure
Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score
time frame: 6 months

Secondary Outcomes

Measure
Difference in Patient Health Questionnaire-9 (PHQ-9) score
time frame: 6 months
Difference in symptom distress, measured using the General Symptom Distress Scale
time frame: 6 months
Difference in Self-care of Heart Failure Index (SCHFI)
time frame: 12 months
Difference in Satisfaction with Healthcare
time frame: 6 months
Difference in pain using the PEG
time frame: 6 months
Change in fatigue using the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue measure
time frame: 6 months
Change in Dyspnea
time frame: 6 months
Change in Sheehan Disability Scale
time frame: 12 months
Change in Quality of Life at the End of Life (QUAL-E)
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial
Principal investigator David Bekelman, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Denver Research Institute.