Trial Outcomes & Findings for Family Palliative and End-of-Life Care for Advanced Heart Failure (NCT NCT04153890)

NCT ID: NCT04153890

Last Updated: 2025-02-19

Results Overview

The patients Heart Failure Health Status was measured by administering the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 12-item Likert scale (range 0-4). Total scores are calculated in a range of 0-100, with the higher score indicating better Heart Failure Health Status.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-02-19

Participant Flow

Participant milestones

Measure	FamPALcare- Patients Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care- Patients The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.	FamPALcare- Caregivers Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care- Caregivers The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Overall Study STARTED	21	18	21	18
Overall Study COMPLETED	12	16	12	16
Overall Study NOT COMPLETED	9	2	9	2

Reasons for withdrawal

Measure	FamPALcare- Patients Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care- Patients The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.	FamPALcare- Caregivers Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care- Caregivers The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Overall Study Lost to Follow-up	9	0	9	0
Overall Study Death	0	2	0	0
Overall Study Withdrawal by Subject	0	0	0	2

Baseline Characteristics

Family Palliative and End-of-Life Care for Advanced Heart Failure

Baseline characteristics by cohort

Measure	FamPALcare- Patients n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care- Patients n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.	FamPALcare- Caregivers n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care- Caregivers n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.	Total n=78 Participants Total of all reporting groups
Age, Continuous	65.57 Years STANDARD_DEVIATION 13.38 • n=5 Participants	65.78 Years STANDARD_DEVIATION 14.51 • n=7 Participants	64.19 Years STANDARD_DEVIATION 11.73 • n=5 Participants	59.55 Years STANDARD_DEVIATION 14.57 • n=4 Participants	63.86 Years STANDARD_DEVIATION 13.48 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants	14 Participants n=4 Participants	43 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	35 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	15 Participants n=7 Participants	19 Participants n=5 Participants	15 Participants n=4 Participants	68 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	18 Participants n=7 Participants	21 Participants n=5 Participants	17 Participants n=4 Participants	77 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	21 Participants n=5 Participants	18 Participants n=7 Participants	21 Participants n=5 Participants	18 Participants n=4 Participants	78 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The patients Heart Failure Health Status was measured by administering the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 12-item Likert scale (range 0-4). Total scores are calculated in a range of 0-100, with the higher score indicating better Heart Failure Health Status.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Patient Heart Failure Health Status (KCCQ)- Baseline	26.79 score on a scale Standard Deviation 18.30	27.11 score on a scale Standard Deviation 14.63

PRIMARY outcome

Timeframe: 3 Month

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The patients Heart Failure Health Status was measured by administering the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 12-item Likert scale (range 0-4). Total scores are calculated in a range of 0-100, with the higher score indicating better Heart Failure Health Status.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Patient Heart Failure Health Status (KCCQ) -3 Month	54.73 score on a scale Standard Deviation 22.58	44.57 score on a scale Standard Deviation 24.54

PRIMARY outcome

Timeframe: 6 Month

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The patients Heart Failure Health Status was measured by administering the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 12-item Likert scale (range 0-4). Total scores are calculated in a range of 0-100, with the higher score indicating better Heart Failure Health Status.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Patient Heart Failure Health Status (KCCQ)- 6 Month	59.49 score on a scale Standard Deviation 21.29	46.00 score on a scale Standard Deviation 23.08

PRIMARY outcome

Timeframe: Baseline

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

Patient-reported mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Patient Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline	5.71 score on a scale Standard Deviation 4.75	5.89 score on a scale Standard Deviation 3.67

PRIMARY outcome

Timeframe: 3 Month

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

Patient-reported mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Patient Mental Health - Patient Health Questionnaire (PHQ4)- 3 Month	2.97 score on a scale Standard Deviation 2.46	3.90 score on a scale Standard Deviation 2.86

PRIMARY outcome

Timeframe: 6 Month

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

Patient-reported mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Patient Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month	2.44 score on a scale Standard Deviation 1.89	4.10 score on a scale Standard Deviation 3.08

PRIMARY outcome

Timeframe: Baseline

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

Caregiver mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline	3.52 score on a scale Standard Deviation 3.72	4.33 score on a scale Standard Deviation 3.60

PRIMARY outcome

Timeframe: 3 Month

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

Caregiver mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 3 Month	2.06 score on a scale Standard Deviation 1.64	4.53 score on a scale Standard Deviation 3.64

PRIMARY outcome

Timeframe: 6 Month

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

Caregiver mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month	2.69 score on a scale Standard Deviation 2.01	4.32 score on a scale Standard Deviation 3.80

PRIMARY outcome

Timeframe: Baseline

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Quality of Life - SF12V2 Health Survey- Baseline (MCS-12)	45.85 score on a scale Standard Deviation 12.83	43.59 score on a scale Standard Deviation 11.91

PRIMARY outcome

Timeframe: 3 Month

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (MCS-12)	47.55 score on a scale Standard Deviation 12.42	42.32 score on a scale Standard Deviation 17.08

PRIMARY outcome

Timeframe: 6 Months

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for both the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (MCS-12)	47.81 score on a scale Standard Deviation 13.44	46.32 score on a scale Standard Deviation 12.06

PRIMARY outcome

Timeframe: Baseline

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Quality of Life - SF12V2 Health Survey- Baseline (PCS-12)	42.40 score on a scale Standard Deviation 13.99	40.48 score on a scale Standard Deviation 14.64

PRIMARY outcome

Timeframe: 3 Month

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (PCS-12)	48.98 score on a scale Standard Deviation 11.07	40.66 score on a scale Standard Deviation 14.16

PRIMARY outcome

Timeframe: 6 Months

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (PCS-12)	44.44 score on a scale Standard Deviation 16.35	41.87 score on a scale Standard Deviation 12.07

PRIMARY outcome

Timeframe: Baseline

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The Zarit Burden Interview-12 (ZBI-12) consists of 12 items that measure the emotional, physical, and social impact of caregiving. There are 12 questions and each question is rated on a 5-point scale from 0 (never) to 4 (nearly always). The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Burden (ZBI-12)- Baseline	8.12 score on a scale Standard Deviation 7.75	13.56 score on a scale Standard Deviation 9.76

PRIMARY outcome

Timeframe: 3 Month

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The Zarit Burden Interview-12 (ZBI-12) consists of 12 items that measure the emotional, physical, and social impact of caregiving. There are 12 questions and each question is rated on a 5-point scale from 0 (never) to 4 (nearly always). The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Burden (ZBI-12)- 3 Month	9.48 score on a scale Standard Deviation 4.23	13.38 score on a scale Standard Deviation 7.02

PRIMARY outcome

Timeframe: 6 Month

Population: The overall number of participants will remain the same throughout the study timepoints as the data analysis was performed with the Intent-To-Treat (ITT) principle.

The Zarit Burden Interview-12 (ZBI-12) consists of 12 items that measure the emotional, physical, and social impact of caregiving. There are 12 questions and each question is rated on a 5-point scale from 0 (never) to 4 (nearly always). The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.

Outcome measures

Measure	FamPALcare n=21 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care n=18 Participants The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Caregiver Burden (ZBI-12)- 6 Month	8.12 score on a scale Standard Deviation 3.67	9.93 score on a scale Standard Deviation 7.16

SECONDARY outcome

Timeframe: 6 months

Population: This was a voluntary questionnaire by participants that had received the intervention. All intervention participants (patients and caregivers) that completed the study were provided with this survey. The number pf participants analyzed represents those that completed the survey.

This scale was completed voluntarily by participants that received the intervention (ARM Title: FamPALcare. The FamPALcare helpfulness scale is an 11-item Likert-type scale used to measure the perceived helpfulness of the FamPALcare intervention. Participants rate each item on a scale from 1 (not helpful) to 5 (very helpful). This scale is used to assess the effectiveness of the intervention in improving outcomes for patients with heart failure and their caregivers.

Outcome measures

Measure	FamPALcare n=9 Participants Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
FamPALcare Helpfulness Scale	4.46 score on a scale Standard Deviation 0.49	—

Adverse Events

FamPALcare- Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care- Patients

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

FamPALcare- Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care- Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	FamPALcare- Patients n=21 participants at risk Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.	Standard Care- Patients n=18 participants at risk The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.	FamPALcare- Caregivers n=21 participants at risk Standard Care plus FamPALcare FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care	Standard Care- Caregivers n=18 participants at risk The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments.
Cardiac disorders Death	0.00% 0/21 • 6 months Adverse Event information was collected during the follow up care visits in both the intervention arm and the standard care arm.	11.1% 2/18 • Number of events 2 • 6 months Adverse Event information was collected during the follow up care visits in both the intervention arm and the standard care arm.	0.00% 0/21 • 6 months Adverse Event information was collected during the follow up care visits in both the intervention arm and the standard care arm.	0.00% 0/18 • 6 months Adverse Event information was collected during the follow up care visits in both the intervention arm and the standard care arm.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ubolrat Piamjariyakul, PhD, RN

West Virginia University School of Nursing

Phone: 3042936729

Email: ubolrat.piamjariyakul@hsc.wvu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place