N/A N=150 Randomized Supportive Care

Palliative Care in Heart Failure

Heart Failure · Heart Diseases · Cardiovascular Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01589601 ↗

Enrolled (actual)

150

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) — 36.1; 31.4; 63.1; 52.1 units on a scale — p=0.1641

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Usual heart failure care (Behavioral); Interdisciplinary palliative care (Behavioral)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)	36.1; 31.4; 63.1; 52.1	0.1641
PRIMARY Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)	120.6; 118.0; 136.5; 125.8	0.5531
SECONDARY Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety	5.7; 7.2; 5.0; 6.0; 3.7; 6.2	0.1592
SECONDARY After-Death Bereaved Family Member Interview - Hospice Version	9.50; 8.87	—
SECONDARY Change in FACIT-Sp	36.4; 35.3; 37.1; 35.9; 39.6; 35.5	0.5857
SECONDARY Utilization and Cost Measured by the Aggregate Cost of Care	—	—
SECONDARY Utilization and Cost Measured by Hospital Readmissions	61; 69; 50; 47; 36; 35	0.56

Summary

The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.

Eligibility Criteria

Inclusion Criteria

Duke University Hospital inpatient adults
Hospitalization for acute decompensated heart failure
Dyspnea (shortness of breath) at rest or minimal exertion plus at least 1 sign of volume overload
Previous heart failure hospitalization within the past 1 year
At significant risk of dying from heart failure in the next 6 months
Anticipated discharge from hospital with anticipated ability to return to outpatient follow-up appointments

Exclusion Criteria

Are not an inpatient at Duke University Hospital
Acute coronary syndrome within 30 days
Cardiac resynchronization therapy (CRT) within the past 3 months or current plan to implant CRT device
Active myocarditis, constrictive pericarditis
Severe stenotic valvular disease amenable to surgical intervention
Anticipated heart transplant or ventricular assist device within 6 months
Renal replacement therapy
Non-cardiac terminal illness
Women who are pregnant or planning to become pregnant
Inability to comply with study protocol
Are not proficient in the English language

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01589601). 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.