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

May 23, 2020 updated by: Marie Anne Bakitas, University of Alabama at Birmingham

ENABLE: CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

High quality trials have demonstrated positive patient and family caregiver outcomes from early palliative care (EPC) in cancer However, given the difficulties in prognostication, the prevalence of sudden cardiac death, and an erratic illness trajectory, it is not clear when or how to integrate palliative care in HF. Furthermore, the high morbidity and mortality of HF in persons with low income, poor education, minority race, and residence in rural, medically-underserviced areas further complicates appropriate timing of integration.

To address these challenges, patients and family members were actively engaged to aid in the development of ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers), a telephonic EPC intervention for rural-dwelling, underserved HF patients and their family caregivers. In a proof-of-concept, formative evaluation study, materials and protocols were translated from our successful EPC ENABLE oncology model to a HF population. This study demonstrated acceptability, feasibility, and a signal of potential efficacy in an educationally, socioeconomically, and racially homogeneous sample of 11 patient-caregiver dyads. Thus, the current ENABLE CHF-PC feasibility trial was conducted in a northeastern and a southeastern US academic center to capture the perspectives of a more demographically and culturally-diverse sample. The purpose of this study was to: 1) determine the feasibility of recruiting and retaining patient-caregiver dyads for 24 weeks in a rural, racially-diverse sample and 2) explore longitudinal patient and caregiver outcomes including QOL, global health, anxiety, and depression to inform intervention and protocol modifications for a larger clinical efficacy trial.

Study Design: In this feasibility study, conducted April 1, 2014 to December 31, 2015, individuals with American College of Cardiology (ACC) /American Heart Association (AHA) Class C/D and/or NYHA Stage III/IV HF and their family caregivers received the ENABLE CHF-PC intervention and were followed for 24 weeks. The study protocol was approved by the institutional review boards of Dartmouth College (Lebanon, New Hampshire) and the University of Alabama at Birmingham (Birmingham, Alabama).

Setting and Sample: Study participants were recruited from cardiology clinics at Dartmouth-Hitchcock Medical Center (DHMC) and the University of Alabama at Birmingham (UAB). Study coordinators at both sites reviewed outpatient cardiology clinic schedules to identify eligible patients. Following physician approval, a study coordinator approached patients and their caregivers during a clinic appointment to explain the study and obtain consent.

Data Collection and Measures: Study coordinators completed measures with patients and caregivers by phone at baseline, 12- and 24-weeks. Baseline demographics included age, gender, race/ethnicity, religion, marital and work status, educational level, and medical insurance. Clinical characteristics abstracted from electronic health records included NYHA class, ejection fraction, presence of an implanted heart device, medications, and laboratory data. These data were entered into the Seattle Heart Failure Model (SHFM) a web-based calculator to compute 1-, 2- and 5-year survival estimates https://depts.washington.edu/shfm/). Nurse coaches also informed patients and caregivers that the purpose of this pilot trial was to determine acceptability in a new population - patients with heart failure from 2 distinctly different regions/cultures. Nurses recorded sessions, and tracked patient and caregiver feedback on intervention components that were found to be helpful or in need of improvement.

Statistical Analysis: The feasibility primary aim was determined by monitoring study status (enrolled, deceased, lost to follow-up) and calculating intervention and measurement completion (e.g. actual # completed/possible # per protocol). Patient and caregiver demographic characteristics were tabulated and compared between sites with bivariate tests of association and effect sizes (Cohen's d or d-equivalent or nominal variables). Associations were assessed between baseline characteristics and participant attrition using simple logistic regressions. Estimated odds ratios were used to determine associations between patient characteristics and attrition.

Longitudinal, fitted, linear mixed methods, adjusted for covariates associated with attrition were used to estimate participant-reported outcomes' changes from baseline to follow-up (12-week and 24-week means combined). Change estimates were transformed to effect sizes (Cohen's d) using baseline estimates of pooled standard deviations. Change was estimated overall and by site. All analyses were conducted using SAS v9.4.

Due to the exploratory nature of the study, the analysis relied on effect size estimation using Cohen's guidelines for magnitude of effect size d (i.e. small: 0.2, moderate: 0.5, and large: 0.8) rather than hypothesis testing to interpret results; however p-values are also provided for completeness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0104
        • University of Alabama at Birmingham
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Dartmouth-Hitchcock Medical Center, Dartmouth College, Dartmouth-Hitchcock Heart & Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patient Inclusion Criteria:

  1. English-speaking and able to complete baseline interview
  2. Age ≥65 (Age criteria was reduced to ≥50 y/o given regional experience with HF population)
  3. NYHA Stage III/IV heart failure; American College of Cardiology (ACC) Class C/D
  4. Have a land-based phone or reliable cellular phone service
  5. 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.

Patient Exclusion Criteria:

  1. Non-correctable hearing loss
  2. Dementia or significant confusion (as measured by a Callahan score of ≤3
  3. Diagnostic and Statistical Manual (DSM) -IV Axis I diagnosis (e.g. schizophrenia, bipolar disorder) or active substance use disorder

Caregiver Inclusion Criteria:

  1. "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."
  2. English-speaking and able to complete baseline interview 3. Have a land-based phone or reliable cellular phone service.

Caregiver Exclusion Criteria:

1. Non-correctable hearing loss.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Summative evaluation trial of ENABLE CHF-PC
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of recruitment for a large-scale RCT.
Time Frame: From Date of Enrollment to 24 Weeks
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.
Time Frame: From Date of Enrollment to 24 Weeks
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.
Time Frame: From Date of Enrollment to 24 Weeks
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.
Time Frame: From Date of Enrollment to 24 Weeks
Number (#) of participants completing outcomes measures by 24 weeks.
From Date of Enrollment to 24 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Quality of Life
Time Frame: Baseline, week 12, and week 24.
Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered HF-specific questionnaire that describes physical limitations (1 item), symptoms (frequency-4 items,severity-3 items, change over time-1 item) self-efficacy/ knowledge (2 items), social interference (1 item) and QOL (3 items). Individual domains show high internal consistency reliability (Cronbach's alpha's .62-.90). It is reported to take 6 minutes to complete. Two summary scores (functional and clinical) can be calculated. It is reported to be more sensitive to clinical change than other HF-specific measures. Scores range from 0-100 wherein higher scores indicate better health status.
Baseline, week 12, and week 24.
Patient Quality of Care
Time Frame: Baseline, week 12, and week 24.
Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient reported measure of chronic illness care (CIC) health counseling behaviors. It consists of the five CIC constructs: patient activation, delivery system/ decision support, goal setting, problem-solving, and follow-up/ coordination. It has good internal consistency with Cronbach alphas ranging from .78 to .90, and test-retest reliability, estimated by intracluster correlation coefficient (ICC), was at least 0.77.
Baseline, week 12, and week 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Palliative Care Research Center (NPCRC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie A. Bakitas, DNSc, NP-C, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • X130827010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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