N/A
Completed N=150
Palliative Care in Heart Failure
Source: ClinicalTrials.gov NCT01589601 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) — 36.1; 31.4; 63.1; 52.1 units on a scale — p=0.1641
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.
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 |
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
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. Informational only — not medical advice.