ENABLE: CHF-PC (Comprehensive Heartcare For Patients and Caregivers)
ENABLE: CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers)
Background: Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. This pilot study engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers).
An EPC feasibility study (4/1/14-8/31/15) was conducted for patients with New York Heart Association (NYHA) Functional Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. Patient- and caregiver-reported outcomes were collected for quality of life (QOL), symptom, health, anxiety, and depression outcomes at baseline, 12- and 24-weeks. Linear mixed-models were used to assess baseline to week 24 longitudinal changes. The intervention was tailored to rural, older adults (age≥65) with advanced HF in reducing HF morbidity and improving patient and caregiver QOL and quality of care.
調査の概要
詳細な説明
High quality trials have demonstrated positive patient and family caregiver outcomes from early palliative care (EPC) in cancer However, given the difficulties in prognostication, the prevalence of sudden cardiac death, and an erratic illness trajectory, it is not clear when or how to integrate palliative care in HF. Furthermore, the high morbidity and mortality of HF in persons with low income, poor education, minority race, and residence in rural, medically-underserviced areas further complicates appropriate timing of integration.
To address these challenges, patients and family members were actively engaged to aid in the development of ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers), a telephonic EPC intervention for rural-dwelling, underserved HF patients and their family caregivers. In a proof-of-concept, formative evaluation study, materials and protocols were translated from our successful EPC ENABLE oncology model to a HF population. This study demonstrated acceptability, feasibility, and a signal of potential efficacy in an educationally, socioeconomically, and racially homogeneous sample of 11 patient-caregiver dyads. Thus, the current ENABLE CHF-PC feasibility trial was conducted in a northeastern and a southeastern US academic center to capture the perspectives of a more demographically and culturally-diverse sample. The purpose of this study was to: 1) determine the feasibility of recruiting and retaining patient-caregiver dyads for 24 weeks in a rural, racially-diverse sample and 2) explore longitudinal patient and caregiver outcomes including QOL, global health, anxiety, and depression to inform intervention and protocol modifications for a larger clinical efficacy trial.
Study Design: In this feasibility study, conducted April 1, 2014 to December 31, 2015, individuals with American College of Cardiology (ACC) /American Heart Association (AHA) Class C/D and/or NYHA Stage III/IV HF and their family caregivers received the ENABLE CHF-PC intervention and were followed for 24 weeks. The study protocol was approved by the institutional review boards of Dartmouth College (Lebanon, New Hampshire) and the University of Alabama at Birmingham (Birmingham, Alabama).
Setting and Sample: Study participants were recruited from cardiology clinics at Dartmouth-Hitchcock Medical Center (DHMC) and the University of Alabama at Birmingham (UAB). Study coordinators at both sites reviewed outpatient cardiology clinic schedules to identify eligible patients. Following physician approval, a study coordinator approached patients and their caregivers during a clinic appointment to explain the study and obtain consent.
Data Collection and Measures: Study coordinators completed measures with patients and caregivers by phone at baseline, 12- and 24-weeks. Baseline demographics included age, gender, race/ethnicity, religion, marital and work status, educational level, and medical insurance. Clinical characteristics abstracted from electronic health records included NYHA class, ejection fraction, presence of an implanted heart device, medications, and laboratory data. These data were entered into the Seattle Heart Failure Model (SHFM) a web-based calculator to compute 1-, 2- and 5-year survival estimates https://depts.washington.edu/shfm/). Nurse coaches also informed patients and caregivers that the purpose of this pilot trial was to determine acceptability in a new population - patients with heart failure from 2 distinctly different regions/cultures. Nurses recorded sessions, and tracked patient and caregiver feedback on intervention components that were found to be helpful or in need of improvement.
Statistical Analysis: The feasibility primary aim was determined by monitoring study status (enrolled, deceased, lost to follow-up) and calculating intervention and measurement completion (e.g. actual # completed/possible # per protocol). Patient and caregiver demographic characteristics were tabulated and compared between sites with bivariate tests of association and effect sizes (Cohen's d or d-equivalent or nominal variables). Associations were assessed between baseline characteristics and participant attrition using simple logistic regressions. Estimated odds ratios were used to determine associations between patient characteristics and attrition.
Longitudinal, fitted, linear mixed methods, adjusted for covariates associated with attrition were used to estimate participant-reported outcomes' changes from baseline to follow-up (12-week and 24-week means combined). Change estimates were transformed to effect sizes (Cohen's d) using baseline estimates of pooled standard deviations. Change was estimated overall and by site. All analyses were conducted using SAS v9.4.
Due to the exploratory nature of the study, the analysis relied on effect size estimation using Cohen's guidelines for magnitude of effect size d (i.e. small: 0.2, moderate: 0.5, and large: 0.8) rather than hypothesis testing to interpret results; however p-values are also provided for completeness.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294-0104
- University of Alabama at Birmingham
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03756-0001
- Dartmouth-Hitchcock Medical Center, Dartmouth College, Dartmouth-Hitchcock Heart & Vascular Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Patient Inclusion Criteria:
- English-speaking and able to complete baseline interview
- Age ≥65 (Age criteria was reduced to ≥50 y/o given regional experience with HF population)
- NYHA Stage III/IV heart failure; American College of Cardiology (ACC) Class C/D
- Have a land-based phone or reliable cellular phone service
- Have an agreeable partner willing to participate in the study* (recommended) *In our previous studies we have not required patients to have a care partner for eligibility. In this study it is essential that we have an adequate number of caregivers to test the caregiver intervention. Therefore patients without a care partner will still be considered but the final study sample size may need to be adjusted to ensure an adequate caregiver sample.
Patient Exclusion Criteria:
- Non-correctable hearing loss
- Dementia or significant confusion (as measured by a Callahan score of ≤3
- Diagnostic and Statistical Manual (DSM) -IV Axis I diagnosis (e.g. schizophrenia, bipolar disorder) or active substance use disorder
Caregiver Inclusion Criteria:
- "Caregiver" is identified by the patient as "a person who knows you well and is involved in your medical care". May be a spouse or adult family member or friend living in the same household or considered by the patient to be the primary caregiver and be willing to participate."
- English-speaking and able to complete baseline interview 3. Have a land-based phone or reliable cellular phone service.
Caregiver Exclusion Criteria:
1. Non-correctable hearing loss.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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他の:Summative evaluation trial of ENABLE CHF-PC
Single arm summative evaluation study was selected for several reasons: 1) to continue to determine recruitment feasibility; 2) retention- our prior work has demonstrated fairly equal dropouts in the intervention and control conditions, hence we believe we will be able to judge retention in a single arm design; 3) using a small randomized controlled trial (RCT) for power estimates runs a high risk of either overestimating or underestimating treatment effects; and 4) most importantly, the primary purpose of this study is to determine intervention efficacy.
Therefore delivering the intervention to the maximum number of participants given the limitations of 2-year pilot funding allows the investigators to obtain the maximal input and experience with the intervention that is needed to achieve the study's Aim 1.
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An Advanced Practice Palliative Care Nurse Coach implements Charting Your Course (CYC), a phone-based, 6-session patient curriculum and a 3-session caregiver curriculum, followed by monthly phone supportive care follow-up.
Sessions 1-3 incorporate Hegel's problem-solving approach that was modified to counsel seriously ill patients using MacMillan's COPE model reactivity, which includes 4 components: Creativity, Optimism, Planning and Expert information.
These sessions address adjusting to chronic illness, symptom management, communication, and decision-making.
Patient sessions 4-6 comprise OUTLOOK, a life review intervention to improve QOL in serious illness developed at Duke.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Feasibility of recruitment for a large-scale RCT.
時間枠:From Date of Enrollment to 24 Weeks
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Number (#) of participants enrolled within 2 years compared to study's target goal.
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From Date of Enrollment to 24 Weeks
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Feasibility of retention for a large-scale RCT.
時間枠:From Date of Enrollment to 24 Weeks
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Number (#) of participants completing study activities by 24 weeks.
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From Date of Enrollment to 24 Weeks
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Feasibility of intervention completion for a large-scale RCT.
時間枠:From Date of Enrollment to 24 Weeks
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Number (#) of participants completing all intervention sessions by 24 weeks.
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From Date of Enrollment to 24 Weeks
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Feasibility of measurement completion for a large-scale RCT.
時間枠:From Date of Enrollment to 24 Weeks
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Number (#) of participants completing outcomes measures by 24 weeks.
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From Date of Enrollment to 24 Weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Patient Quality of Life
時間枠:Baseline, week 12, and week 24.
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Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered HF-specific questionnaire that describes physical limitations (1 item), symptoms (frequency-4 items,severity-3 items, change over time-1 item) self-efficacy/ knowledge (2 items), social interference (1 item) and QOL (3 items).
Individual domains show high internal consistency reliability (Cronbach's alpha's .62-.90).
It is reported to take 6 minutes to complete.
Two summary scores (functional and clinical) can be calculated.
It is reported to be more sensitive to clinical change than other HF-specific measures.
Scores range from 0-100 wherein higher scores indicate better health status.
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Baseline, week 12, and week 24.
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Patient Quality of Care
時間枠:Baseline, week 12, and week 24.
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Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient reported measure of chronic illness care (CIC) health counseling behaviors.
It consists of the five CIC constructs: patient activation, delivery system/ decision support, goal setting, problem-solving, and follow-up/ coordination.
It has good internal consistency with Cronbach alphas ranging from .78 to .90, and test-retest reliability, estimated by intracluster correlation coefficient (ICC), was at least 0.77.
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Baseline, week 12, and week 24.
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協力者と研究者
捜査官
- 主任研究者:Marie A. Bakitas, DNSc, NP-C、University of Alabama at Birmingham
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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心不全、うっ血性の臨床試験
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Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)
ENABLE CHF-PCの臨床試験
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University of Alabama at BirminghamUS Department of Veterans Affairs完了
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Chiesi Farmaceutici S.p.A.SGS S.A.完了
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Chiesi Farmaceutici S.p.A.完了
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Medtronic Bakken Research Center完了
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Yaounde Central Hospital招待による登録
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KU LeuvenAmsterdam UMC, location VUmc; Agentschap voor Innovatie door Wetenschap en Technologie; University... と他の協力者わからない
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Chang Gung Memorial HospitalTaipei Veterans General Hospital, Taiwan; Taipei Medical University; National Yang Ming Universityまだ募集していませんアトピー性皮膚炎