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临床试验/NCT04840407
NCT04840407已完成不适用

Assessing a Stroke Home Health Aide Recovery Program (SHARP) as a Potential High Impact Strategy for Improving Functional Mobility After Stroke

Visiting Nurse Service of New York1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Evaluate SHARP recruitment and randomization procedures

研究概览

简要总结

The project pilot tests an innovative Stroke Home health Aide Recovery Program (SHARP) designed to improve mobility and reduce falls in post-acute home bound stroke patients. SHARP will accomplish this by expanding the home-based rehabilitation team to include a corps of advanced HHAs specially trained as stroke "peer coaches." Coaches provide mentorship and support to generalist HHAs as they collaborate with patients and families to implement the therapeutic regimens prescribed by patients' physicians and rehabilitation therapists.

详细描述

Purpose and Specific Aims This is a pilot to test the Stroke Home health Aide Recovery Program (SHARP) study design elements and procedures in preparation for a larger-scale study that would assess the effectiveness of the model to improve patient outcomes. The overall purpose of SHARP and of this research pilot is to improve patients' function following a stroke. SHARP is designed to improve mobility and reduce falls in post-acute homebound stroke patients by expanding the rehabilitation team to include SHARP Home Health Aides (HHAs) specially trained as stroke "peer coaches." The coaches will provide mentorship and support to direct care generalist HHAs. The direct care HHAs will already be working with patients and families on the exercise regimen prescribed by physicians and rehabilitation therapists.

Main aims are to:

  1. Test recruitment and randomization procedures
  2. Examine program acceptability
  3. Assess intervention protocol implementation fidelity
  4. Examine patient burden, and obtain preliminary estimates of variability/reliability/correlation over time of selected outcomes

Population and Intervention Potential candidates for the SHARP coach positions are drawn from recommendations of HHA field supervisors and from additional HHA volunteers. All must have already completed the Partners in Care health coach introductory program or the equivalent. Nominated candidates will be interviewed by Research and Partners in Care staff to select up to 10 HHA's to engage in SHARP coach training. After coach preparation, rehabilitation therapists are to help identify post-stroke patients who meet the initial pilot study eligibility criteria. A VNSNY Research Assistant reaches out to patients referred by the therapists to assess their interest and eligibility, to explain the intervention and terms of participation and, once patients agree to participate, to obtain their formal consent. After consent, patients are randomized to an intervention or control arm. SHARP coaches are deployed to help with post-stroke rehabilitation care for those randomized to the intervention arm. A total of 60 patients will be recruited - 30 for the intervention arm and 30 for the usual care arm.

Potential Significance The SHARP program that is being developed through this study has the potential to be a high impact approach to enhance home-based post-stroke rehabilitation and improve functional mobility and related outcomes among homebound post-stroke patients. This project represents foundational work for the development of a novel community based approach to enhance stroke recovery. By leveraging an existing infrastructure of paraprofessional care providers (the HHAs), this program may offer a practical and sustainable method for enhancing post-acute care of stroke patients during the critical transition phase from hospital/rehab center to home, and provide a framework for a new cadre of advanced, specialty HHAs. Qualitative and quantitative data derived from this pilot will inform feasibility, study procedures and effect sizes for a larger randomized trial assessing the impact of the SHARP coaching on patient outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • English Speaking
  • Receiving home health rehabilitation services
  • Receiving HHA services
  • No diagnosis of Alzheimer's or Dementia
  • Experienced a stroke within 90 days of start of home care services
  • Mobility is impaired but requires no or only minimal assistance and has rehabilitation potential
  • Was able to walk independently or with assistance pre-stroke

排除标准

  • Unable to provide informed consent

结局指标

主要结局

Evaluate SHARP recruitment and randomization procedures

时间窗: 20 months

Examine ability to recruit and orient home health aides to be SHARP coaches; evaluate ability to identify and enroll the patient group of interest

Assess SHARP program acceptability to coaches/HHAs/patients

时间窗: 30 minutes

Examination of participant experience and satisfaction with the SHARP program

Assess SHARP implementation fidelity

时间窗: 15 months

Monitoring of all workflows and planned intervention activities to determine fidelity to the protocol and adjustments that may be needed in a future trial

Examine selected covariates and primary and secondary outcome measures for a subsequent larger scale study of SHARP effectiveness

时间窗: 60 days

Examination of patient burden and evaluation preliminary estimates of variability, reliability, and correlation of clinical evaluation measures

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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