Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Conditions
Keywords
advanced heart failure, breathlessness, supportive care
Brief summary
Overall objective is to test whether the 5-weekly family home palliative and end-of-life care (FamPALcare) intervention educational and supportive sessions will improve rural home end-of-life and palliative care (EOLPC) for advanced heart failure at 6 months follow up.
Detailed description
Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers especially during severe symptoms in the long-lasting end stage. Advanced HF was defined by American Heart Association (AHA) as the presence of progressive and/or persistent severe signs and symptoms of HF despite optimized medical, surgical, and device therapy. When patients and family members are not prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options, they experience depression, fear of painful death, home care burden, and medical expenses from anxiously seeking aggressive but futile care. Notably, West Virginia (WV) has the highest HF death in the U.S. at 32.6 per 100,000 population, where 14% of those over 65 years have HF. WV is in the large Appalachian region, which stretches across eastern North America with 25.6 million people and contains a vast number of disadvantaged rural communities. National Institutes of Health has designated Appalachia as a high priority for research as residents experience extreme health and poverty inequities and limited access to healthcare. Furthermore, home EOLPC is lacking across this disadvantaged rural area. Thus, there is a need to investigate the new family intervention (FamPALcare), where nurses coach family-managed advanced HF care at home in Appalachia. This study addresses the National Institutes of Health Academic Research Enhancement Award (AREA) priorities for conducting a low risk clinical trials to provide a foundation to advance scientific EOLPC knowledge and testing of our intervention efficacy in larger clinical trials. Additionally, effective EOLPC interventions are priorities of palliative care professionals and palliative care needs must be addressed with vulnerable and advanced HF patients and their families. This study also addresses the priority problem of the lack information for families providing advanced HF home care and preventing unwanted and unwarranted rehospitalizations at the advanced stage of HF. This study uses a randomized controlled trial (RCT) design stratified by gender (male vs female) to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care control group outcomes (N=72). Specific aims are to: (1) Test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF in rural WV using a small randomized controlled trial (RCT) and (2) Assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials. The control patients receive standard care given through the West Virginia University hospital and outpatient clinics, prescribed by the patient's cardiologist. The FamPALcare intervention group will receive standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. FamPALcare intervention involves coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions. Data will be collected from all patients and caregivers independently at baseline, 3 months, and 6 months.
Interventions
BEHAVIORALFamPALcare
Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.
Sponsors
National Institute of Nursing Research (NINR)
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Care provider and outcome assessor including data collectors will be blinded to group assignment.
Intervention model description
This study is a low-risk randomized control trial design to test the implementation of the FamPALcare intervention with advanced HF patients and their primary family caregivers.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Alert and consent to participate 2. Able to read and understand English 3. Advanced HF (NYHA III or IV), diagnosed by physician
Exclusion criteria
1. Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD) 2. Diagnosed with a terminal illness or dementia, such as Alzheimer's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Burden (ZBI-12)- 6 Month | 6 Month | 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. |
| Patient Heart Failure Health Status (KCCQ)- Baseline | Baseline | 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. |
| Patient Heart Failure Health Status (KCCQ) -3 Month | 3 Month | 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. |
| Patient Heart Failure Health Status (KCCQ)- 6 Month | 6 Month | 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. |
| Patient Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline | Baseline | 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. |
| Patient Mental Health - Patient Health Questionnaire (PHQ4)- 3 Month | 3 Month | 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. |
| Patient Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month | 6 Month | 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. |
| Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline | Baseline | 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. |
| Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 3 Month | 3 Month | 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. |
| Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month | 6 Month | 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. |
| Caregiver Quality of Life - SF12V2 Health Survey- Baseline (MCS-12) | Baseline | 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. |
| Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (MCS-12) | 3 Month | 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. |
| Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (MCS-12) | 6 Months | 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. |
| Caregiver Quality of Life - SF12V2 Health Survey- Baseline (PCS-12) | Baseline | 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. |
| Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (PCS-12) | 3 Month | 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. |
| Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (PCS-12) | 6 Months | 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. |
| Caregiver Burden (ZBI-12)- Baseline | Baseline | 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. |
| Caregiver Burden (ZBI-12)- 3 Month | 3 Month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FamPALcare Helpfulness Scale | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Standard Care- Patients The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. | 18 |
| 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. | 21 |
| Standard Care- Caregivers The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. | 18 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 9 | 0 | 9 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Standard Care- Caregivers | FamPALcare- Caregivers | FamPALcare- Patients | Standard Care- Patients |
|---|---|---|---|---|---|
| Age, Continuous | 63.86 Years STANDARD_DEVIATION 13.48 | 59.55 Years STANDARD_DEVIATION 14.57 | 64.19 Years STANDARD_DEVIATION 11.73 | 65.57 Years STANDARD_DEVIATION 13.38 | 65.78 Years STANDARD_DEVIATION 14.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants | 17 Participants | 21 Participants | 21 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 68 Participants | 15 Participants | 19 Participants | 19 Participants | 15 Participants |
| Region of Enrollment United States | 78 Participants | 18 Participants | 21 Participants | 21 Participants | 18 Participants |
| Sex: Female, Male Female | 43 Participants | 14 Participants | 16 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 35 Participants | 4 Participants | 5 Participants | 15 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 2 / 18 | 0 / 21 | 0 / 18 |
| other Total, other adverse events | 0 / 21 | 0 / 18 | 0 / 21 | 0 / 18 |
| serious Total, serious adverse events | 0 / 21 | 2 / 18 | 0 / 21 | 0 / 18 |
Outcome results
Primary
Caregiver Burden (ZBI-12)- 3 Month
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Burden (ZBI-12)- 3 Month | 9.48 score on a scale | Standard Deviation 4.23 |
| Standard Care | Caregiver Burden (ZBI-12)- 3 Month | 13.38 score on a scale | Standard Deviation 7.02 |
Primary
Caregiver Burden (ZBI-12)- 6 Month
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Burden (ZBI-12)- 6 Month | 8.12 score on a scale | Standard Deviation 3.67 |
| Standard Care | Caregiver Burden (ZBI-12)- 6 Month | 9.93 score on a scale | Standard Deviation 7.16 |
Primary
Caregiver Burden (ZBI-12)- Baseline
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Burden (ZBI-12)- Baseline | 8.12 score on a scale | Standard Deviation 7.75 |
| Standard Care | Caregiver Burden (ZBI-12)- Baseline | 13.56 score on a scale | Standard Deviation 9.76 |
Primary
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 3 Month
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 3 Month | 2.06 score on a scale | Standard Deviation 1.64 |
| Standard Care | Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 3 Month | 4.53 score on a scale | Standard Deviation 3.64 |
Primary
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month | 2.69 score on a scale | Standard Deviation 2.01 |
| Standard Care | Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month | 4.32 score on a scale | Standard Deviation 3.8 |
Primary
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline | 3.52 score on a scale | Standard Deviation 3.72 |
| Standard Care | Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline | 4.33 score on a scale | Standard Deviation 3.6 |
Primary
Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (MCS-12)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (MCS-12) | 47.55 score on a scale | Standard Deviation 12.42 |
| Standard Care | Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (MCS-12) | 42.32 score on a scale | Standard Deviation 17.08 |
Primary
Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (PCS-12)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (PCS-12) | 48.98 score on a scale | Standard Deviation 11.07 |
| Standard Care | Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (PCS-12) | 40.66 score on a scale | Standard Deviation 14.16 |
Primary
Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (MCS-12)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (MCS-12) | 47.81 score on a scale | Standard Deviation 13.44 |
| Standard Care | Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (MCS-12) | 46.32 score on a scale | Standard Deviation 12.06 |
Primary
Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (PCS-12)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (PCS-12) | 44.44 score on a scale | Standard Deviation 16.35 |
| Standard Care | Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (PCS-12) | 41.87 score on a scale | Standard Deviation 12.07 |
Primary
Caregiver Quality of Life - SF12V2 Health Survey- Baseline (MCS-12)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Quality of Life - SF12V2 Health Survey- Baseline (MCS-12) | 45.85 score on a scale | Standard Deviation 12.83 |
| Standard Care | Caregiver Quality of Life - SF12V2 Health Survey- Baseline (MCS-12) | 43.59 score on a scale | Standard Deviation 11.91 |
Primary
Caregiver Quality of Life - SF12V2 Health Survey- Baseline (PCS-12)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Caregiver Quality of Life - SF12V2 Health Survey- Baseline (PCS-12) | 42.40 score on a scale | Standard Deviation 13.99 |
| Standard Care | Caregiver Quality of Life - SF12V2 Health Survey- Baseline (PCS-12) | 40.48 score on a scale | Standard Deviation 14.64 |
Primary
Patient Heart Failure Health Status (KCCQ) -3 Month
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Patient Heart Failure Health Status (KCCQ) -3 Month | 54.73 score on a scale | Standard Deviation 22.58 |
| Standard Care | Patient Heart Failure Health Status (KCCQ) -3 Month | 44.57 score on a scale | Standard Deviation 24.54 |
Primary
Patient Heart Failure Health Status (KCCQ)- 6 Month
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Patient Heart Failure Health Status (KCCQ)- 6 Month | 59.49 score on a scale | Standard Deviation 21.29 |
| Standard Care | Patient Heart Failure Health Status (KCCQ)- 6 Month | 46.00 score on a scale | Standard Deviation 23.08 |
Primary
Patient Heart Failure Health Status (KCCQ)- Baseline
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Patient Heart Failure Health Status (KCCQ)- Baseline | 26.79 score on a scale | Standard Deviation 18.3 |
| Standard Care | Patient Heart Failure Health Status (KCCQ)- Baseline | 27.11 score on a scale | Standard Deviation 14.63 |
Primary
Patient Mental Health - Patient Health Questionnaire (PHQ4)- 3 Month
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Patient Mental Health - Patient Health Questionnaire (PHQ4)- 3 Month | 2.97 score on a scale | Standard Deviation 2.46 |
| Standard Care | Patient Mental Health - Patient Health Questionnaire (PHQ4)- 3 Month | 3.90 score on a scale | Standard Deviation 2.86 |
Primary
Patient Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Patient Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month | 2.44 score on a scale | Standard Deviation 1.89 |
| Standard Care | Patient Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month | 4.10 score on a scale | Standard Deviation 3.08 |
Primary
Patient Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | Patient Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline | 5.71 score on a scale | Standard Deviation 4.75 |
| Standard Care | Patient Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline | 5.89 score on a scale | Standard Deviation 3.67 |
Secondary
FamPALcare Helpfulness Scale
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FamPALcare | FamPALcare Helpfulness Scale | 4.46 score on a scale | Standard Deviation 0.49 |