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

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ClinicalTrials.gov Identifier: NCT02505425
Recruitment Status : Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Marie Anne Bakitas, University of Alabama at Birmingham

Brief Summary:

Advanced heart failure affects nearly 6 million Americans, and less is known about how this illness affects the 80% of heart failure patients who are 65 years and older because research tends to focus on younger patients. Older patients with heart failure and their family caregivers, rarely have access to palliative supportive care services because the disease is unpredictable and palliative treatment may not be provided until after other medical treatments have been tried. Investigators are studying whether palliative care provided when advanced heart failure patients are still well will result in better quality of life, mood and less symptom distress compared to usual or standard heart failure care.

Specific Aims and Hypotheses:

Specific Aim 1: Determine whether ENABLE: CHF-PC leads to higher advanced heart failure patient-reported quality of life (QOL) and mood (depression/anxiety); and lower symptom burden and resource use (e.g. hospital admissions and days, emergency visits) at 8 and 16 weeks after baseline.

• Hypothesis 1: Intervention participants will experience higher QOL and mood, and lower symptom burden and resource use at 8 and 16 weeks after baseline compared with those receiving usual HF care.

Specific Aim 2: Determine whether ENABLE: CHF-PC leads to higher caregiver-reported QOL, mood (anxiety/depression), and self-reported health and lower caregiver burden at 8 and 16 weeks after baseline.

• Hypothesis 2: Intervention caregivers will report higher QOL, mood, and self-reported health, and lower caregiver burden at 8 and 16 weeks after baseline.


Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Behavioral Support Behavioral: Usual HF Care Not Applicable

Detailed Description:
As described.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 608 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of ENABLE CHF-PC for Heart Failure Patients and Caregivers. (Comprehensive Heartcare For Patients and Caregivers)
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : October 20, 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Intervention

Behavioral: behavioral support

Usual HF Care + ENABLE CHF-PC

Behavioral: Behavioral Support

ENABLE CHF-PC includes:

  1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.
  2. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.

The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families".

Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.

Other Name: ENABLE CHF-PC

Active Comparator: Usual HF Care
Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
Behavioral: Usual HF Care
Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
Other Name: Usual Heart Failure Care




Primary Outcome Measures :
  1. Patient quality of life [ Time Frame: 8 & 16 weeks post baseline ]
    Change from baseline in patient-reported quality of life (QOL) measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 8 weeks; change from baseline measured on the KCCQ at 16 weeks.

  2. Patient mood - depression & anxiety [ Time Frame: 8 & 16 weeks post baseline ]
    Change from baseline in patient-reported mood measured on the Hospital Anxiety and Depression Scale (HADS) at 8 weeks; change from baseline in patient-reported mood measured on the HADS at 16 weeks.

  3. Caregiver quality of life [ Time Frame: 8 weeks and 16 weeks post baseline ]
    Change from baseline in caregiver-reported quality of life (QOL) measured on Bakas Caregiving Outcomes Scale (BCOS) at 8 weeks; change from baseline in BCOS at 16 weeks.

  4. Caregiver mood - depression & anxiety [ Time Frame: 8 weeks and 16 weeks after baseline ]
    Change from baseline in caregiver-reported mood measured on the Hospital Anxiety and Depression Scale (HADS) at 8 weeks; change from baseline in patient-reported mood on the HADS at 16 weeks.

  5. Caregiver burden [ Time Frame: 8 weeks and 16 weeks after baseline ]
    Change from baseline in caregiver-reported burden measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) at 8 weeks; change from baseline in caregiver-reported burden measured on the MBCB at 16 weeks.


Secondary Outcome Measures :
  1. Patient and caregiver health status [ Time Frame: 8 weeks and 16 weeks after baseline ]
    Change from baseline in patient- and caregiver-reported health status measured on the PROMIS SF Global Health at 8 weeks post baseline; Change from baseline in patient- and caregiver-reported health status measured on the PROMIS SF 16 weeks post baseline.

  2. Patient symptom burden [ Time Frame: Time Frame: 8 weeks and 16 weeks post baseline ]
    Change from baseline in patient-reported symptom burden measured on the FACIT-Pal 14, The PROMIS Pain Intensity Scale, PROMIS Pain Interference items and symptom-based items from the KCCQ at 8 weeks; change from baseline in patient-reported symptom burden measured on this same set of instruments at 16 weeks.

  3. Patient resource use (e.g. hospital admissions and days, emergency visits) [ Time Frame: 8 weeks and 16 weeks post baseline ]
    Change from baseline in patient-reported health care utilization measured on the Resource Use Questionnaire at 8 weeks; change from baseline in patient-reported mood measured on the Resource Use Questionnaire at 16 weeks.


Other Outcome Measures:
  1. Exploratory Aim 1. Explore mediators and or moderators of patient and or caregiver outcomes and reciprocal relationships [ Time Frame: Multiple ]
    Measure intervention effect, if any, on patient quality of life, mood, and symptom burden mediated by the quality of chronic illness care Patient Assessment of Chronic Illness Care (PACIC). Assess reciprocal relationships measured on Dyadic Heart Failure (HF) Care Typology (trait) and the Dyadic Adjustment Scale 7-item-SF (DAS7-SF) at 8 weeks; change from baseline in DAS7-SF at mulitple data points.

  2. Exploratory Aim 1. Explore mediators and or moderators of patient and or caregiver outcomes and reciprocal relationships [ Time Frame: Multiple ]
    Measure the effect, if any, on caregiver quality of life, mood, and burden mediated by patient well-being; on patient- and caregiver-reported spiritual/ religious coping measured on the Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS); change from baseline at multiple data points.

  3. Exploratory Aim 2. Examine intervention effects, if any, on both quality of life and survival using joint modeling approaches. [ Time Frame: Baseline to study end or patient death ]
    Survival - Construct estimates of mean survival time in each intervention group weighted by longitudinal quality of life measures.



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Able to read and understand English
  2. NYHF III/IV heart failure (physician-determined)

Exclusion Criteria:

  1. Dementia or significant confusion (Callahan 6-Item Cognitive Screening score ≤ 3)
  2. DSM-IV Axis I diagnosis (e.g. schizophrenia, bipolar disorder, or active substance use disorder)
  3. Patients will not be excluded if they do not identify a caregiver
  4. Uncorrectable hearing loss.

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): NCT02505425


Locations
United States, Alabama
Birmingham Veterans Affairs Medical Center (BVAMC)
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham, School of Nursing, Dept. Acute, Chronic and Continuing Care
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
US Department of Veterans Affairs
Investigators
Principal Investigator: Marie Bakitas, DNSc University of Alabama at Birmimgham, School of Nursing, Dept. Acute, Chronic and Continuing Care

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marie Anne Bakitas, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02505425     History of Changes
Other Study ID Numbers: X140813007
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this time, the study plans to share data in aggregate and as overall results only.

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases