Stroke Home Health Aide Recovery Program (SHARP) Pilot

NCT04840407 | Completed

• 1 other identifier: I17-007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

home health aides; workforce

Outcome Measures

Primary Outcomes (4)

• 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

• Assess SHARP program acceptability to coaches/HHAs/patients

  Examination of participant experience and satisfaction with the SHARP program

  30 minutes

• 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

• 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

Study Arms (2)

SHARP coach arm

EXPERIMENTAL

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).

Behavioral: SHARP coach intervention

Usual care arm

NO INTERVENTION

Interventions

SHARP coach intervention BEHAVIORAL

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.

SHARP coach arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Visiting Nurse Service of New York: lead
• Columbia University: collaborator

Study Sites (1)

Visiting Nurse Service of New York

New York, New York, 10001, United States

Location

Related Publications (1)

• 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.

  PMID: 35101133 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: May 7, 2018
• Primary Completion: August 26, 2019
• Study Completion: August 31, 2019
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)