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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03402906
• Other study ID #: E-991-17
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2017
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: Kessler Foundation
• Contact: Emma Kaplan
• Phone: 973-243-6880
• Email: ekaplan[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spatial Neglect
• Stroke

Intervention

Behavioral:
• Family-Clinician Collaboration Program
Family-mediated treatment activities and collaboration between clinician and family members

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	FCC feedback	Semi-structured interview on the experience of the study participation	Immediately after intervention
Secondary	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
Secondary	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