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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Spatial Neglect
• Intervention / Treatment: Behavioral: Family-Clinician Collaboration Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Kaplan; Phone Number: 973-243-6880; Email: ekaplan@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Contact: Emma Kaplan; Phone Number: 973-243-6880; Email: ekaplan@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Unilateral right brain stroke
• Functionally independent before stroke
• Presence of spatial neglect (moderate to severe, will be confirmed during the screening session)
• Ability to follow instructions and understand verbal or written English
• Currently living with a family member who will be enrolled into the study as well

Exclusion Criteria:

• History of progressive neurological disorder
• History of a significant psychiatric disorder
• Living outside of 50-mile radius of Kessler Foundation (West Orange, NJ)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family-Clinician Collaboration; Participants are dyads of a stroke survivor and their family member. 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 stroke survivor at home.	Behavioral: Family-Clinician Collaboration Program; Family-mediated treatment activities and collaboration between clinician and family members; Other Names: FCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatial neglect assessment battery	Searching visual targets, writing, reading, drawing, and other tasks that require exploration of the person's surroundings. The primary outcome measure is the change between before and immediately after intervention.	Before and immediately after intervention
Family caregiver wellness	Self-reported questionnaires regarding emotional status, caregiving stress and burden. The primary outcome measure is the change between before and immediately after intervention.	Before and immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FCC feedback	Semi-structured interview on the experience of the study participation	Immediately after intervention
Spatial neglect assessment battery	Searching visual targets, writing, reading, drawing, and other tasks that require exploration of the person's surroundings. The outcome measure is the change between immediately after intervention and 4-week follow-up.	4 weeks after intervention
Family caregiver wellness	Self-reported questionnaires regarding emotional status, caregiving stress and burden. The outcome measure is the change between immediately after intervention and 4-week follow-up.	4 weeks after intervention

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Principal Investigator: Peii Chen, PhD, Kessler Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2017
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: E-991-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No