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Trial record 2 of 1695 for:    PC trial

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

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ClinicalTrials.gov Identifier: NCT03177447
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : June 7, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heart Failure, Congestive Behavioral: ENABLE CHF-PC

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: ENABLE: CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers)
Actual Study Start Date : July 1, 2013
Primary Completion Date : December 31, 2015
Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Eligibility Criteria

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177447

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0104
United States, New Hampshire
Dartmouth-Hitchcock Medical Center, Dartmouth College, Dartmouth-Hitchcock Heart & Vascular Center
Lebanon, New Hampshire, United States, 03756-0001
Sponsors and Collaborators
University of Alabama at Birmingham
National Palliative Care Research Center (NPCRC)
Principal Investigator: Marie A. Bakitas, DNSc, NP-C University of Alabama at Birmingham
More Information

Responsible Party: Marie Anne Bakitas, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03177447     History of Changes
Other Study ID Numbers: X130827010
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marie Anne Bakitas, University of Alabama at Birmingham:
Cardiac Failure
Congestive Heart Failure
Heart Decompensation
Heart Failure, Congestive

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases