ENABLE: CHF-PC (Comprehensive Heartcare For Patients and Caregivers)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03177447|
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : June 7, 2017
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||Phase|
|Heart Failure, Congestive||Behavioral: ENABLE CHF-PC||Not Applicable|
Show Detailed Description
|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|
|Actual Primary Completion Date :||December 31, 2015|
|Actual Study Completion Date :||December 31, 2015|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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|
|Principal Investigator:||Marie A. Bakitas, DNSc, NP-C||University of Alabama at Birmingham|