ENABLE CHF-PC (Comprehensive Heartcare For Patients and Caregivers)
Status: | Active, not recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 12/8/2018 |
Start Date: | November 30, 2015 |
End Date: | December 2021 |
Randomized Trial of ENABLE CHF-PC for Heart Failure Patients and Caregivers. (Comprehensive Heartcare For Patients and Caregivers)
Advanced heart failure affects nearly 6 million Americans, and less is known about how this
illness affects the 80% of heart failure patients who are 65 years and older because research
tends to focus on younger patients. Older patients with heart failure and their family
caregivers, rarely have access to palliative supportive care services because the disease is
unpredictable and palliative treatment may not be provided until after other medical
treatments have been tried. Investigators are studying whether palliative care provided when
advanced heart failure patients are still well will result in better quality of life, mood
and less symptom distress compared to usual or standard heart failure care.
Specific Aims and Hypotheses:
Specific Aim 1: Determine whether ENABLE: CHF-PC leads to higher advanced heart failure
patient-reported quality of life (QOL) and mood (depression/anxiety); and lower symptom
burden and resource use (e.g. hospital admissions and days, emergency visits) at 8 and 16
weeks after baseline.
• Hypothesis 1: Intervention participants will experience higher QOL and mood, and lower
symptom burden and resource use at 8 and 16 weeks after baseline compared with those
receiving usual HF care.
Specific Aim 2: Determine whether ENABLE: CHF-PC leads to higher caregiver-reported QOL, mood
(anxiety/depression), and self-reported health and lower caregiver burden at 8 and 16 weeks
after baseline.
• Hypothesis 2: Intervention caregivers will report higher QOL, mood, and self-reported
health, and lower caregiver burden at 8 and 16 weeks after baseline.
illness affects the 80% of heart failure patients who are 65 years and older because research
tends to focus on younger patients. Older patients with heart failure and their family
caregivers, rarely have access to palliative supportive care services because the disease is
unpredictable and palliative treatment may not be provided until after other medical
treatments have been tried. Investigators are studying whether palliative care provided when
advanced heart failure patients are still well will result in better quality of life, mood
and less symptom distress compared to usual or standard heart failure care.
Specific Aims and Hypotheses:
Specific Aim 1: Determine whether ENABLE: CHF-PC leads to higher advanced heart failure
patient-reported quality of life (QOL) and mood (depression/anxiety); and lower symptom
burden and resource use (e.g. hospital admissions and days, emergency visits) at 8 and 16
weeks after baseline.
• Hypothesis 1: Intervention participants will experience higher QOL and mood, and lower
symptom burden and resource use at 8 and 16 weeks after baseline compared with those
receiving usual HF care.
Specific Aim 2: Determine whether ENABLE: CHF-PC leads to higher caregiver-reported QOL, mood
(anxiety/depression), and self-reported health and lower caregiver burden at 8 and 16 weeks
after baseline.
• Hypothesis 2: Intervention caregivers will report higher QOL, mood, and self-reported
health, and lower caregiver burden at 8 and 16 weeks after baseline.
As described.
Inclusion Criteria:
1. Able to read and understand English
2. NYHF III/IV heart failure (physician-determined)
Exclusion Criteria:
1. Dementia or significant confusion (Callahan 6-Item Cognitive Screening score ≤ 3)
2. DSM-IV Axis I diagnosis (e.g. schizophrenia, bipolar disorder, or active substance use
disorder)
3. Patients will not be excluded if they do not identify a caregiver
4. Uncorrectable hearing loss.
We found this trial at
2
sites
Birmingham, Alabama 35233
Principal Investigator: Marie Bakitas, DNSc, NP-C, FAAN
Phone: (205) 934-5277
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Birmingham, Alabama 35233
Principal Investigator: Kathryn L Burgio, PhD
Phone: 205-933-8101
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