ENABLE CHF-PC (Comprehensive Heartcare For Patients and Caregivers)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

573 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-05-10

Brief Summary

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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) through 16 weeks post baseline.

• Hypothesis 1: Intervention participants will experience higher QOL and mood, and lower symptom burden and resource use through 16 weeks post 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 through 16 weeks post baseline.

• Hypothesis 2: Intervention caregivers will report higher QOL, mood, and self-reported health, and lower caregiver burden through 16 weeks post baseline.

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Detailed Description

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As described.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Intervention

Behavioral: behavioral support

Usual HF Care + ENABLE CHF-PC

Group Type EXPERIMENTAL

Behavioral Support

Intervention Type BEHAVIORAL

ENABLE CHF-PC includes:

1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.
2. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.

The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families".

Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.

Usual HF Care

Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.

Group Type ACTIVE_COMPARATOR

Usual HF Care

Intervention Type BEHAVIORAL

Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.

Interventions

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Behavioral Support

ENABLE CHF-PC includes:

1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.
2. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.

The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families".

Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.

Intervention Type BEHAVIORAL

Usual HF Care

Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.

Intervention Type BEHAVIORAL

Other Intervention Names

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ENABLE CHF-PC Usual Heart Failure Care

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No