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

NCT04153890 | Completed Results DMC

• 2 other identifiers: 17097549881R15NR018547-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Keywords

advanced heart failure, breathlessness, supportive care

Outcome Measures

Primary Outcomes (18)

• 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.

  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

Secondary Outcomes (1)

• FamPALcare Helpfulness Scale

  6 months

Study Arms (2)

FamPALcare

EXPERIMENTAL

FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.

Behavioral: FamPALcare

Standard Care

NO INTERVENTION

The standard care group will receive routine HF care and instruction at university hospital or at clinic.

Interventions

FamPALcare BEHAVIORAL

Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.

FamPALcare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alert and consent to participate
• Able to read and understand English
• Advanced HF (NYHA III or IV), diagnosed by physician

You may not qualify if:

• Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD)
• Diagnosed with a terminal illness or dementia, such as Alzheimer's disease

Sponsors & Collaborators

• West Virginia University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Related Publications (4)

• 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.

  PMID: 31884945 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.

  PMID: 34720774 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.

  PMID: 38352285 BACKGROUND

• 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.

  PMID: 39097733 RESULT

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Ubolrat Piamjariyakul, PhD, RN
• Organization: West Virginia University School of Nursing

ubolrat.piamjariyakul@hsc.wvu.edu

3042936729

Study Officials

• Ubolrat Piamjariyakul, PhD, RN

  West Virginia University, School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care provider and outcome assessor including data collectors will be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research and Scholarship

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: January 13, 2020
• Primary Completion: July 31, 2023
• Study Completion: September 1, 2023
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)