Physical Rehabilitation for Older Patients with Acute HFpEF-The REHAB-HFpEF Trial

老年急性 HFpEF 患者的身体康复 - REHAB-HFpEF 试验

基本信息

批准号：
10683332
负责人：
DALANE W KITZMAN
金额：
$ 701.02万
依托单位：
WAKE FOREST UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-15 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10683332
关键词：
Accident and Emergency department Acute Address Affect Age Attention Black Populations Blood Banks Blood specimen Caregivers Cessation of life Clinic Visits Clinical Cognition Congestive Heart Failure Data Dissemination and Implementation EFRAC Educational workshop Elderly Enrollment Ensure Event Evidence based treatment Funding Future Geography Guidelines Health Care Costs Health system Heart failure Home Hospitalization Impairment Institutionalization Intervention Leadership Medical Medicare claim Mental Depression Morbidity - disease rate Multicenter Trials National Heart, Lung, and Blood Institute Not Hispanic or Latino Outcome Participant Pathway interactions Patient-Focused Outcomes Patients Pharmaceutical Preparations Phase Phenotype Physical Function Physical Performance Physical Rehabilitation Physical activity Prevalence Randomized Recommendation Reporting Research Personnel Resources Structure Subgroup Syndrome Testing Time Underserved Population Vulnerable Populations Walking Woman adjudication attentional control clinical care clinical center cost effectiveness cost estimate disability experience falls follow-up frailty health care service utilization health related quality of life heart preservation high risk high risk population hospital readmission improved innovation intervention effect intervention program meter mortality multidisciplinary novel older patient older women phase II trial physical conditioning physically handicapped preservation primary endpoint primary outcome response secondary endpoint secondary outcome single-blind trial treatment as usual trend

项目摘要

Acute decompensated heart failure (ADHF) is the leading cause of hospitalization in older persons, and is associated with marked physical disability, poor health-related quality of life (HRQOL), frequent rehospitalizations, loss of independence, high mortality, and enormous health care costs. However, most of the trials testing a wide range of medications and strategies in ADHF have been neutral. In our recently completed NIA-funded phase 2 trial (REHAB-HF), an innovative, early, transitional, tailored, and progressive multi-domain physical rehabilitation intervention produced a large improvement in the primary outcome of Short Physical Performance Battery (+1.5 points) in older patients with ADHF. At baseline, the participants (53%) with HF with preserved ejection fraction (HFpEF), had significantly worse impairments in physical function, frailty, HRQOL, and depression than those with HF with reduced EF. They also appeared to derive greater benefit from the intervention, with ~50% larger effect sizes in physical function, frailty, HRQOL, and depression. Patients with HFpEF also appeared to have much greater reductions in rehospitalizations and death and potential for reduced medical resource use. The finding of potentially greater benefit in HFpEF is noteworthy as HFpEF is highly relevant to older persons and has the most urgent need for new treatments since it is: 1) the most common form of HF, nearly unique to older persons, and disproportionately affects older women and Black persons; 2) increasing in prevalence; 3) accepted as a geriatric syndrome; 4) associated with marked impairments in physical function and HRQOL and high rates of frailty; 5) has high morbidity and mortality which are worsening over time; and 6) has limited evidence-based treatments. The phase 3 REHAB- HFpEF trial will focus on this large, growing, vulnerable, underserved population. The 5-year, randomized, attention-controlled, single-blinded trial will enroll 880 older adults age >60 years with ADHF and HFpEF across 20 geographically dispersed clinical centers. We will test the hypothesis that the innovative REHAB-HF intervention will improve the clinically compelling combined primary endpoint of all-cause rehospitalizations and mortality during 6-month follow-up, the most vulnerable time period following ADHF hospitalization (Aim 1) and the secondary endpoint of prevalence of major mobility disability, a clinically meaningful outcome in trials of older adults, at 6-months (Aim 2). We will also assess the intervention’s impact on HRQOL, frailty, depression, physical activity, and health care costs. Our diverse, cohesive, multi-disciplinary team and experience from the phase 2 trial will ensure efficient and effective execution and dissemination. REHAB-HFpEF directly addresses the key recommendations of several recent NIA and NHLBI sponsored workshops. Its results could improve key outcomes that are meaningful to patients, caregivers, health systems, and payers. The trial has strong potential to change clinical guidelines, reduce health care costs, and influence national coverage decisions for the large, growing, underserved, high-risk population of older patients with acute HFpEF.

急性代偿性心力衰竭（ADHF）是老年人住院的主要原因，是与明显的身体残疾，与健康相关的生活质量差（HRQOL），频率相关重新培育化，独立性丧失，高死亡率和巨大的医疗保健费用。但是，大多数在ADHF中测试广泛的药物和策略的试验是中性的。在我们最近完成了NIA资助的2阶段试验（Rehab-HF），这是一种创新的，早期的，过渡的，量身定制的和进步的多域身体康复干预措施在短时 ADHF老年患者的身体性能电池（+1.5分）。在基线时，参与者（53％）具有保留射血分数（HFPEF）的HF，其身体机能的损害明显较差，脆弱，HRQOL和抑郁症比患有EF降低的HF的人。他们似乎也得出了更大的干预措施受益，身体机能，脆弱，HRQOL和沮丧。 HFPEF的患者在重新住院和死亡和减少医疗资源使用的潜力。在HFPEF中可能更大的好处的发现是值得注意的是，HFPEF与老年人高度相关，并且最迫切需要新治疗因为它是：1）最常见的HF形式，几乎是老年人独有的，并且对老年人的影响不成比例妇女和黑人； 2）患病率增加； 3）被接受为老年综合症； 4）关联身体机能和HRQOL的明显损害以及较高的脆弱率； 5）发病率高和随着时间的流逝而后悔的死亡率； 6）基于证据的治疗有限。第三阶段康复 - HFPEF试验将集中于这个大型，增长，脆弱，服务不足的人群。 5年，随机的注意力控制的单盲试验将以ADHF和HFPEF招募880名老年人> 60岁在20个地理分散的临床中心中。我们将测试创新的康复HF的假设干预措施将改善全因重新考虑和在6个月的随访期间的死亡率，ADHF住院后最脆弱的时期（AIM 1）和主要流动性残疾的次要终点老年人，6个月（AIM 2）。我们还将评估干预对HRQOL，脆弱，抑郁症，体育活动和医疗保健费用。我们的潜水员，凝聚力，多学科团队以及来自 2阶段试验将确保有效的执行和传播。 REHABH-HFPEF直接解决最近几个NIA和NHLBI赞助了研讨会的主要建议。它的结果可以改善对患者，护理人员，卫生系统和付款人有意义的关键结果。审判有很强有可能改变临床准则，降低医疗保健成本并影响国家覆盖范围急性HFPEF患者的大型，增长，服务不足的高危人群的决定。

项目成果

期刊论文数量（1）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Comparative effectiveness of pelvic floor muscle training, mirabegron, and trospium among older women with urgency urinary incontinence and high fall risk: a feasibility randomized clinical study.

DOI：
10.1186/s40814-023-01440-w
发表时间：
2024-01-04
期刊：
PILOT AND FEASIBILITY STUDIES
影响因子：
1.7
作者：
Fisher, Steve R.;Villasante-Tezanos, Alejandro;Allen, Lindsay M.;Pappadis, Monique R.;Kilic, Gokhan
通讯作者：
Kilic, Gokhan