Clinical trial NCT01739686: Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial
Official title: Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Quality of Life
Symptoms
Palliative care
Symptom management
Disease management
Health delivery
Lead sponsor: Denver Research Institute
Sponsor class: OTHER
Collaborators: name: VA Eastern Colorado Health Care System
name: University of Colorado, Denver
name: Denver Health Medical Center
name: University of Iowa
First posted: 2012-12-03
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score
timeFrame: 6 months
Secondary outcomes:
measure: Difference in Patient Health Questionnaire-9 (PHQ-9) score
timeFrame: 6 months
measure: Difference in symptom distress, measured using the General Symptom Distress Scale
timeFrame: 6 months
measure: Difference in Self-care of Heart Failure Index (SCHFI)
timeFrame: 12 months
measure: Difference in Satisfaction with Healthcare
timeFrame: 6 months
measure: Difference in pain using the PEG
timeFrame: 6 months
measure: Change in fatigue using the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue measure
timeFrame: 6 months
measure: Change in Dyspnea
timeFrame: 6 months
measure: Change in Sheehan Disability Scale
timeFrame: 12 months
measure: Change in Quality of Life at the End of Life (QUAL-E)
timeFrame: 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System(ECHCS)
state: Colorado
Study officials:
affiliation: Denver Research Institute
name: David Bekelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bekelman DB, Allen LA, McBryde CF, Hattler B, Fairclough DL, Havranek EP, Turvey C, Meek PM. Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):511-519. doi: 10.1001/jamainternmed.2017.8667.
citation: Bekelman DB, Allen LA, Peterson J, Hattler B, Havranek EP, Fairclough DL, McBryde CF, Meek PM. Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial. Contemp Clin Trials. 2016 Nov;51:1-7. doi: 10.1016/j.cct.2016.09.002. Epub 2016 Sep 12.