Clinical trial NCT03402906: 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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Spatial Neglect
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Spatial neglect assessment battery
timeFrame: Before and immediately after intervention
measure: Family caregiver wellness
timeFrame: Before and immediately after intervention
Secondary outcomes:
measure: FCC feedback
timeFrame: Immediately after intervention
measure: Spatial neglect assessment battery
timeFrame: 4 weeks after intervention
measure: Family caregiver wellness
timeFrame: 4 weeks after intervention
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Peii Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.