Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02505425
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2015-07-08
Brief Title:
ENABLE CHF-PC Comprehensive Heartcare For Patients and Caregivers
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Randomized Trial of ENABLE CHF-PC for Heart Failure Patients and Caregivers Comprehensive Heartcare For Patients and Caregivers
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENABLE CHF PC
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 depressionanxiety and lower symptom burden and resource use eg hospital admissions and days emergency visits through 16 weeks post baseline
Hypothesis 1 Intervention participants will experience higher QOL and mood and lower symptom burden and resource use through 16 weeks post baseline compared with those receiving usual HF care
Specific Aim 2 Determine whether ENABLE CHF-PC leads to higher caregiver-reported QOL mood anxietydepression and self-reported health and lower caregiver burden through 16 weeks post baseline
Hypothesis 2 Intervention caregivers will report higher QOL mood and self-reported health and lower caregiver burden through 16 weeks post baseline
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 depressionanxiety and lower symptom burden and resource use eg hospital admissions and days emergency visits through 16 weeks post baseline
Hypothesis 1 Intervention participants will experience higher QOL and mood and lower symptom burden and resource use through 16 weeks post baseline compared with those receiving usual HF care
Specific Aim 2 Determine whether ENABLE CHF-PC leads to higher caregiver-reported QOL mood anxietydepression and self-reported health and lower caregiver burden through 16 weeks post baseline
Hypothesis 2 Intervention caregivers will report higher QOL mood and self-reported health and lower caregiver burden through 16 weeks post baseline
Detailed Description:
As described
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None