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| ID | Type | Description | Link |
|---|---|---|---|
| 1R15NR018547-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FamPALcare | Experimental | FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care. |
|
| Standard Care | No Intervention | The standard care group will receive routine HF care and instruction at university hospital or at clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FamPALcare | Behavioral | Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 3 Month |
| 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. | 6 Month |
| 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. | Baseline |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ubolrat Piamjariyakul, PhD, RN | West Virginia University, School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31884945 | Background | Piamjariyakul U, Petitte T, Smothers A, Wen S, Morrissey E, Young S, Sokos G, Moss AH, Smith CE. Study protocol of coaching end-of-life palliative care for advanced heart failure patients and their family caregivers in rural appalachia: a randomized controlled trial. BMC Palliat Care. 2019 Dec 29;18(1):119. doi: 10.1186/s12904-019-0500-z. | |
| 34720774 | Background | Piamjariyakul U, Keener TA, Smothers A, Young S, Shafique S, McDill S, Keech K, Petitte T, Pacheco C. Mentoring Undergraduate Nursing Students in Palliative Home Care Research. Teach Learn Nurs. 2021 Oct;16(4):423-428. doi: 10.1016/j.teln.2021.05.001. Epub 2021 Jun 5. No abstract available. |
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The study plans to share data in aggregate and as overall study results.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard Care- Patients | The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. |
| FG002 | 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. |
| FG003 | Standard Care- Caregivers | The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard Care- Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
6 months
Adverse Event information was collected during the follow up care visits in both the intervention arm and the standard care arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
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There was an expected delay in our initial enrollment during winter (December to March) due to extreme weather and road conditions in rural Appalachia and COVID-19 restrictions (December 2019 through Mid-2022). However, only slight variation in participant intervention timelines was necessary in a few cases. The flexibility of the intervention schedule helped with the retention of participants in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ubolrat Piamjariyakul, PhD, RN | West Virginia University School of Nursing | 3042936729 | ubolrat.piamjariyakul@hsc.wvu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 29, 2019 | Jan 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2019 | Nov 15, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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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.
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Care provider and outcome assessor including data collectors will be blinded to group assignment.
| 3 Month |
| 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. | 6 Month |
| 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. | Baseline |
| 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. | 3 Month |
| 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. | 6 Month |
| 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. | Baseline |
| 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. | 3 Month |
| 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. | 6 Months |
| 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. | Baseline |
| 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. | 3 Month |
| 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. | 6 Months |
| 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. | Baseline |
| 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. | 3 Month |
| 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. | 6 Month |
| 6 months |
| 38352285 | Background | Piamjariyakul U, Shafique S, Friend DL, Adams KA, Sanghuachang W, Petitte TM, Young S. The development and evaluation of a short-term international student research and educational program. Int J Nurs Sci. 2023 Dec 6;11(1):83-90. doi: 10.1016/j.ijnss.2023.12.001. eCollection 2024 Jan. |
| 39097733 | Result | Piamjariyakul U, Smothers A, Wang K, Shafique S, Wen S, Petitte T, Young S, Sokos G, Smith CE. Palliative care for patients with heart failure and family caregivers in rural Appalachia: a randomized controlled trial. BMC Palliat Care. 2024 Aug 3;23(1):199. doi: 10.1186/s12904-024-01531-2. |
| Death |
|
| Withdrawal by Subject |
|
The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. |
| BG002 | 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. |
| BG003 | Standard Care- Caregivers | The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Standard Care |
The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Month |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Month |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Month |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Month |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 Month |
|
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Month |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Standard Care- Patients | The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. | 2 | 18 | 2 | 18 | 0 | 18 |
| EG002 | 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 | 0 | 21 | 0 | 21 | 0 | 21 |
| EG003 | Standard Care- Caregivers | The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |