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Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke

Primary Purpose

Stroke, Spatial Neglect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-Clinician Collaboration Program
Standard Care at KIR
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Latest stroke occurred within last 60 days
  • Functionally independent before latest stroke
  • Presence of spatial neglect (moderate to severe, will be confirmed by medical records)
  • Ability to follow instructions and understand verbal or written English

Exclusion Criteria:

  • History of progressive neurological disorder
  • History of a significant psychiatric disorder

Sites / Locations

  • Kessler Foundation Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Family-Clinician Collaboration

Control

Arm Description

Experimental group which will be performing the Family-Clinician Collaboration Program. Family members will work closely with the Clinician to understand the status and goals of the stroke survivor, and family members will integrate Family-Mediated Treatment Procedures into their time spent with the patient. Intervention: Behavioral - Family-Clinician Collaboration Program; Behavioral - Standard Care at KIR

Control group in which patient will receive the standard treatment provided at Kessler Institute for Rehabilitation (KIR). Intervention: Behavioral - Standard Care at KIR

Outcomes

Primary Outcome Measures

Functional Independence Measure (FIM™)
Assessment of overall functional independence.

Secondary Outcome Measures

Full Information

First Posted
January 2, 2018
Last Updated
March 7, 2023
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03402906
Brief Title
Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke
Official Title
Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
September 29, 2018 (Actual)
Study Completion Date
September 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

4. Oversight

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

5. Study Description

Brief Summary
Spatial neglect may occur in patients who have had a stroke. People with spatial neglect often pay much more attention to one side of the body while ignoring the other side, even though they have no difficulty seeing. The purpose of this study is to evaluate the impact on stroke recovery, including spatial neglect, of the Family-Clinician Collaboration program, where a family member of a stroke survivor actively interacts with clinical staff members providing inpatient rehabilitation services to the stroke survivor.
Detailed Description
Spatial neglect (SN) frequently occurs in patients who have had a stroke. The problems caused by SN result in patients failing to attend to the space contralateral to the side of the stroke. This failure to attend to half of the patient's field may result in problems with perception, memory, action planning and navigation. These deficits hurt both the patients and their caregivers, and make it difficult for them to resume daily activities as they were before the stroke. More than half of the patients who had SN at admission still had it when discharged from an inpatient rehabilitation facility. This study examines a new behavioral treatment, where the clinician and the caregiver work together to provide better treatment. The family members will engage in frequent meetings with clinicians, set goals, learn about SN and coping strategies and have the patient to perform easy, safe treatment exercises. The study will compare this Family-Clinician Collaboration with the inpatient treatment control. This study will compare the groups in measures of spatial neglect and independence in the patients and measures of caretaker burden and mental health in family members. Participants will also report on their overall opinions of the new treatment condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spatial Neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family-Clinician Collaboration
Arm Type
Experimental
Arm Description
Experimental group which will be performing the Family-Clinician Collaboration Program. Family members will work closely with the Clinician to understand the status and goals of the stroke survivor, and family members will integrate Family-Mediated Treatment Procedures into their time spent with the patient. Intervention: Behavioral - Family-Clinician Collaboration Program; Behavioral - Standard Care at KIR
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Control group in which patient will receive the standard treatment provided at Kessler Institute for Rehabilitation (KIR). Intervention: Behavioral - Standard Care at KIR
Intervention Type
Behavioral
Intervention Name(s)
Family-Clinician Collaboration Program
Other Intervention Name(s)
FCC
Intervention Description
Family-mediated treatment activities and collaboration between clinician and family members
Intervention Type
Behavioral
Intervention Name(s)
Standard Care at KIR
Intervention Description
Participants will receive the standard care provided at Kessler Institute for Rehabilitation.
Primary Outcome Measure Information:
Title
Functional Independence Measure (FIM™)
Description
Assessment of overall functional independence.
Time Frame
Within 72 hours before IRF discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Latest stroke occurred within last 60 days Functionally independent before latest stroke Presence of spatial neglect (moderate to severe, will be confirmed by medical records) Ability to follow instructions and understand verbal or written English Exclusion Criteria: History of progressive neurological disorder History of a significant psychiatric disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peii Chen, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation Research Center
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34196963
Citation
Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
Results Reference
derived

Learn more about this trial

Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke

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