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

NCT03177447 | Completed

• 1 other identifier: X130827010
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure, Congestive

Keywords

Cardiac Failure; Congestive Heart Failure; Heart Decompensation; Heart Failure, Congestive

Outcome Measures

Primary Outcomes (4)

• Feasibility of recruitment for a large-scale RCT.

  Number (#) of participants enrolled within 2 years compared to study's target goal.

  From Date of Enrollment to 24 Weeks

• Feasibility of retention for a large-scale RCT.

  Number (#) of participants completing study activities by 24 weeks.

  From Date of Enrollment to 24 Weeks

• Feasibility of intervention completion for a large-scale RCT.

  Number (#) of participants completing all intervention sessions by 24 weeks.

  From Date of Enrollment to 24 Weeks

• Feasibility of measurement completion for a large-scale RCT.

  Number (#) of participants completing outcomes measures by 24 weeks.

  From Date of Enrollment to 24 Weeks

Secondary Outcomes (2)

• Patient Quality of Life

  Baseline, week 12, and week 24.

• Patient Quality of Care

  Baseline, week 12, and week 24.

Study Arms (1)

Summative evaluation trial of ENABLE CHF-PC

OTHER

Single arm summative evaluation study was selected for several reasons: 1) to continue to determine recruitment feasibility; 2) retention- our prior work has demonstrated fairly equal dropouts in the intervention and control conditions, hence we believe we will be able to judge retention in a single arm design; 3) using a small randomized controlled trial (RCT) for power estimates runs a high risk of either overestimating or underestimating treatment effects; and 4) most importantly, the primary purpose of this study is to determine intervention efficacy. Therefore delivering the intervention to the maximum number of participants given the limitations of 2-year pilot funding allows the investigators to obtain the maximal input and experience with the intervention that is needed to achieve the study's Aim 1.

Behavioral: ENABLE CHF-PC

Interventions

ENABLE CHF-PC BEHAVIORAL

An Advanced Practice Palliative Care Nurse Coach implements Charting Your Course (CYC), a phone-based, 6-session patient curriculum and a 3-session caregiver curriculum, followed by monthly phone supportive care follow-up. Sessions 1-3 incorporate Hegel's problem-solving approach that was modified to counsel seriously ill patients using MacMillan's COPE model reactivity, which includes 4 components: Creativity, Optimism, Planning and Expert information. These sessions address adjusting to chronic illness, symptom management, communication, and decision-making. Patient sessions 4-6 comprise OUTLOOK, a life review intervention to improve QOL in serious illness developed at Duke.

Summative evaluation trial of ENABLE CHF-PC

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• "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.
• \. Non-correctable hearing loss.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Palliative Care Research Center: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0104, United States

Location

Dartmouth-Hitchcock Medical Center, Dartmouth College, Dartmouth-Hitchcock Heart & Vascular Center

Lebanon, New Hampshire, 03756-0001, United States

Location

Related Publications (1)

• Bakitas M, Dionne-Odom JN, Pamboukian SV, Tallaj J, Kvale E, Swetz KM, Frost J, Wells R, Azuero A, Keebler K, Akyar I, Ejem D, Steinhauser K, Smith T, Durant R, Kono AT. Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial. BMC Palliat Care. 2017 Aug 31;16(1):45. doi: 10.1186/s12904-017-0226-8.

  PMID: 28859648 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Marie A. Bakitas, DNSc, NP-C

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: June 6, 2017
• Study Start: July 1, 2013
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)