Stroke Home Health Aide Recovery Program (SHARP) Pilot

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840407
• Other study ID #: I17-007
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2021
• Source: Visiting Nurse Service of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2019
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older

2. English Speaking

3. Receiving home health rehabilitation services

4. Receiving HHA services

5. No diagnosis of Alzheimer's or Dementia

6. Experienced a stroke within 90 days of start of home care services

7. Mobility is impaired but requires no or only minimal assistance and has rehabilitation potential

8. Was able to walk independently or with assistance pre-stroke

Exclusion Criteria:

• Unable to provide informed consent

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• SHARP coach intervention
The Coach provides guidance and support through four 45-60 minute in-home visits: Visit 1: to facilitate effective team communication, this visit is conducted, when possible, with the rehabilitation therapist, the patient/family, the direct care aide and the Coach, who jointly reviews the rehabilitation plan of care. Visits 2-4 include: discussion/observation of HHA/patient exercise repetition sessions, along with: 1) discussing falls prevention, signs of a recurrent stroke and when to call 911; 2) modeling motivation techniques, assessing adherence barriers and revising strategies for addressing them; and 3) identifying/ reporting signs of anxiety/depression. Additional coaching visits and calls may be scheduled as needed depending on the aide's progress in addressing barriers and the patient's progress toward rehabilitation goals.

Locations

Country	Name	City	State
United States	Visiting Nurse Service of New York	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Visiting Nurse Service of New York	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate SHARP recruitment and randomization procedures	Examine ability to recruit and orient home health aides to be SHARP coaches; evaluate ability to identify and enroll the patient group of interest	20 months
Primary	Assess SHARP program acceptability to coaches/HHAs/patients	Examination of participant experience and satisfaction with the SHARP program	30 minutes
Primary	Assess SHARP implementation fidelity	Monitoring of all workflows and planned intervention activities to determine fidelity to the protocol and adjustments that may be needed in a future trial	15 months
Primary	Examine selected covariates and primary and secondary outcome measures for a subsequent larger scale study of SHARP effectiveness	Examination of patient burden and evaluation preliminary estimates of variability, reliability, and correlation of clinical evaluation measures	60 days