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

Not Applicable

Recruiting

• Conditions: Stroke; Spatial Neglect
• Interventions: Behavioral: Family-Clinician Collaboration Program

• Registration Number: NCT03402906
• Lead Sponsor: Kessler Foundation

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.

Study Timeline

• Study Start: 2017-09-30
• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Family-Clinician Collaboration	Family-Clinician Collaboration Program	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.

Primary Outcome Measures

Name	Time	Method
Spatial neglect assessment battery	Before and immediately after intervention	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.
Family caregiver wellness	Before and immediately after intervention	Self-reported questionnaires regarding emotional status, caregiving stress and burden.; The primary outcome measure is the change between before and immediately after intervention.

Secondary Outcome Measures

Name	Time	Method
Family caregiver wellness	4 weeks after intervention	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.
Spatial neglect assessment battery	4 weeks after intervention	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.
FCC feedback	Immediately after intervention	Semi-structured interview on the experience of the study participation

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States