Sustaining Home Heart Failure Palliative Care in Rural Appalachia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorWest Virginia University
About this trial
The aim of this mixed methods randomized controlled trial is to test the integrated nurse-led intervention bundle for family home care management of end-stage heart failure and palliative care in rural Appalachia. This intervention bundle is designed to address rural disparities in access to health care, with the help of the faith-based nurses and local volunteer visiting neighbors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients' age between 50 to 80 years with advanced HF (NYHA III or IV), diagnosed by physician
Caregivers' age between 45 to 80 years.
Alert and consent to participate
Able to read and understand English
Disqualifiers
Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD)
Diagnosed with a terminal illness or dementia, such as Alzheimer's disease
Trial design
Design model
Parallel
Treatments tested in this trial
HF-FamPALhomeCARE
BehavioralParticipants in HF-FamPALhomeCARE Intervention group receive standard care plus 2 home visits, 3 bi-weekly telephone call on HF home EOLPC care, and follow-up telephone calls at 3, 6, 9, and 12 months.
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: HF-FamPALhomeCAREExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Measures patients' Heart Failure (HF) status \& physical function status. Each item is scored on a scale from 0 to 4 or 0 to 5, depending on the question. The overall score range is 0-100 with a higher score indicating better HF health status.
Time frame
Baseline2
Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Measures patients' Heart Failure (HF) status \& physical function status. Each item is scored on a scale from 0 to 4 or 0 to 5, depending on the question. The overall score range is 0-100 with a higher score indicating better HF health status.
Time frame
3 Month Follow up3
Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Measures patients' Heart Failure (HF) status \& physical function status. Each item is scored on a scale from 0 to 4 or 0 to 5, depending on the question. The overall score range is 0-100 with a higher score indicating better HF health status.
Time frame
6 Month Follow up4
Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Measures patients' Heart Failure (HF) status \& physical function status. Each item is scored on a scale from 0 to 4 or 0 to 5, depending on the question. The overall score range is 0-100 with a higher score indicating better HF health status.
Time frame
9 Month Follow upSecondary outcomes
1
Patient--Patient Health Questionnaire-9 (PHQ-9)
Patient Assessed: The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, and measure the severity of depression. It consists of nine questions with each question scored from 0 to 3 (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater depressive symptoms.
Time frame
Baseline2
Patient--Patient Health Questionnaire-9 (PHQ-9)
Patient Assessed: The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, and measure the severity of depression. It consists of nine questions with each question scored from 0 to 3 (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater depressive symptoms.
Time frame
3 Month Follow up3
Patient--Patient Health Questionnaire-9 (PHQ-9)
Patient Assessed: The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, and measure the severity of depression. It consists of nine questions with each question scored from 0 to 3 (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater depressive symptoms.
Time frame
6 Month Follow up4
Patient--Patient Health Questionnaire-9 (PHQ-9)
Patient Assessed: The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, and measure the severity of depression. It consists of nine questions with each question scored from 0 to 3 (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater depressive symptoms.
Time frame
9 Month Follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
West Virginia University
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov