ENABLE: CHF-PC (Comprehensive Heartcare For Patients and Caregivers) (NCT03177447) | Clinical Trial Compass
CompletedNot Applicable
ENABLE: CHF-PC (Comprehensive Heartcare For Patients and Caregivers)
United States62 participantsStarted 2013-07-01
Plain-language summary
Background: Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. This pilot study engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers).
An EPC feasibility study (4/1/14-8/31/15) was conducted for patients with New York Heart Association (NYHA) Functional Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. Patient- and caregiver-reported outcomes were collected for quality of life (QOL), symptom, health, anxiety, and depression outcomes at baseline, 12- and 24-weeks. Linear mixed-models were used to assess baseline to week 24 longitudinal changes. The intervention was tailored to rural, older adults (age≥65) with advanced HF in reducing HF morbidity and improving patient and caregiver QOL and quality of care.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. English-speaking and able to complete baseline interview
✓. Age ≥65 (Age criteria was reduced to ≥50 y/o given regional experience with HF population)
✓. NYHA Stage III/IV heart failure; American College of Cardiology (ACC) Class C/D
✓. Have a land-based phone or reliable cellular phone service
✓. Have an agreeable partner willing to participate in the study\* (recommended) \*In our previous studies we have not required patients to have a care partner for eligibility. In this study it is essential that we have an adequate number of caregivers to test the caregiver intervention. Therefore patients without a care partner will still be considered but the final study sample size may need to be adjusted to ensure an adequate caregiver sample.
Exclusion criteria
✕. Non-correctable hearing loss
✕. Dementia or significant confusion (as measured by a Callahan score of ≤3
✕. Diagnostic and Statistical Manual (DSM) -IV Axis I diagnosis (e.g. schizophrenia, bipolar disorder) or active substance use disorder
What they're measuring
1
Feasibility of recruitment for a large-scale RCT.
Timeframe: From Date of Enrollment to 24 Weeks
2
Feasibility of retention for a large-scale RCT.
Timeframe: From Date of Enrollment to 24 Weeks
3
Feasibility of intervention completion for a large-scale RCT.
Timeframe: From Date of Enrollment to 24 Weeks
4
Feasibility of measurement completion for a large-scale RCT.
✕. "Caregiver" is identified by the patient as "a person who knows you well and is involved in your medical care". May be a spouse or adult family member or friend living in the same household or considered by the patient to be the primary caregiver and be willing to participate."
✕. English-speaking and able to complete baseline interview 3. Have a land-based phone or reliable cellular phone service.