N/A N=30 Randomized Supportive Care

Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study

Chronic Heart Failure (CHF)

Bottom Line

View on ClinicalTrials.gov: NCT01581008 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcome: Primary: Cohort Retention — 16; 7 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Collaborative Care to Alleviate Symptoms and Adjust to Illness (Other); Psychospiritual (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Cohort Retention	16; 7	—
SECONDARY Was Depression Addressed?	4; 4; 2; 2	—
SECONDARY Participation Rates	17; 13	—
SECONDARY Adherence to the Study Protocol (CASA Arm Only)	94	—

Summary

The overall goal of this study is to evaluate the pilot implementation of two palliative care interventions in veterans with chronic heart failure at the Denver VA Medical Center. This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.

Eligibility Criteria

Inclusion Criteria

eligible veterans from the Denver VAMC will have a prior primary discharge diagnosis of heart failure in the last year,
be at least 18 years of age, able to read and understand English,
have consistent access to a telephone
at least one of the following:
Kansas City Cardiomyopathy Questionnaire (KCCQ) score less than or equal to 60;
a second hospitalization for with a primary discharge diagnosis of heart failure in the last year;
taking at least 80 mg oral furosemide (or equivalent) daily in a single or divided dose for at least 2 weeks;
BNP greater than or equal to 250 or NT-proBNP greater than or equal to 1000; or
estimated creatinine clearance 30-80 mL/min.

Exclusion Criteria

previous diagnosis of dementia;
active substance abuse, defined as an AUDIT-C score greater than 7, two positive responses on substance abuse screening questions, or medical records indicating active substance abuse or dependence;
comorbid metastatic cancer, given the focus on heart failure palliative care;
nursing home resident; and
diagnosis of bipolar disorder or schizophrenia.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01581008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.