search
Back to results

Stroke Home Health Aide Recovery Program (SHARP) Pilot

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHARP coach intervention
Sponsored by
Visiting Nurse Service of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring home health aides, workforce

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Visiting Nurse Service of New York

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SHARP coach arm

Usual care arm

Arm Description

The SHARP Peer Coach supports the direct care HHA and indirectly support the patient/family caregiver to enhance the patient's post-stroke recovery through two main pathways: 1) culturally sensitive, patient-centered reinforcement of rehabilitation regimens (prescribed physical/occupational exercises/training); and 2) early recognition and reporting of barriers to the rehabilitation therapist regarding adherence and recovery, including: a) environmental obstacles, b) family-related issues, c) psychological/clinical barriers (e.g., depression/anxiety).

Outcomes

Primary Outcome Measures

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
Assess SHARP program acceptability to coaches/HHAs/patients
Examination of participant experience and satisfaction with the SHARP program
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
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

Secondary Outcome Measures

Full Information

First Posted
April 7, 2021
Last Updated
April 8, 2021
Sponsor
Visiting Nurse Service of New York
Collaborators
Columbia University
search

1. Study Identification

Unique Protocol Identification Number
NCT04840407
Brief Title
Stroke Home Health Aide Recovery Program (SHARP) Pilot
Official Title
Assessing a Stroke Home Health Aide Recovery Program (SHARP) as a Potential High Impact Strategy for Improving Functional Mobility After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visiting Nurse Service of New York
Collaborators
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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: Test recruitment and randomization procedures Examine program acceptability Assess intervention protocol implementation fidelity 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
home health aides, workforce

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHARP coach arm
Arm Type
Experimental
Arm Description
The SHARP Peer Coach supports the direct care HHA and indirectly support the patient/family caregiver to enhance the patient's post-stroke recovery through two main pathways: 1) culturally sensitive, patient-centered reinforcement of rehabilitation regimens (prescribed physical/occupational exercises/training); and 2) early recognition and reporting of barriers to the rehabilitation therapist regarding adherence and recovery, including: a) environmental obstacles, b) family-related issues, c) psychological/clinical barriers (e.g., depression/anxiety).
Arm Title
Usual care arm
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
SHARP coach intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate SHARP recruitment and randomization procedures
Description
Examine ability to recruit and orient home health aides to be SHARP coaches; evaluate ability to identify and enroll the patient group of interest
Time Frame
20 months
Title
Assess SHARP program acceptability to coaches/HHAs/patients
Description
Examination of participant experience and satisfaction with the SHARP program
Time Frame
30 minutes
Title
Assess SHARP implementation fidelity
Description
Monitoring of all workflows and planned intervention activities to determine fidelity to the protocol and adjustments that may be needed in a future trial
Time Frame
15 months
Title
Examine selected covariates and primary and secondary outcome measures for a subsequent larger scale study of SHARP effectiveness
Description
Examination of patient burden and evaluation preliminary estimates of variability, reliability, and correlation of clinical evaluation measures
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Unable to provide informed consent
Facility Information:
Facility Name
Visiting Nurse Service of New York
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35101133
Citation
Feldman PH, McDonald MV, Onorato N, Stein J, Williams O. Feasibility of deploying peer coaches to mentor frontline home health aides and promote mobility among individuals recovering from a stroke: pilot test of a randomized controlled trial. Pilot Feasibility Stud. 2022 Jan 31;8(1):22. doi: 10.1186/s40814-022-00979-4.
Results Reference
derived

Learn more about this trial

Stroke Home Health Aide Recovery Program (SHARP) Pilot

We'll reach out to this number within 24 hrs