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TerminatedNCT03402906Updated Nov 25, 2025

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

An interventional study of Family-Clinician Collaboration Program in Stroke and Spatial Neglect, sponsored by Kessler Foundation. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment

Why this study was terminated
Insufficient funding
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke
  • Spatial Neglect

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralFamily-Clinician Collaboration Program

    Family-mediated treatment activities and collaboration between clinician and family members

    Also known as: FCC

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before and immediately after intervention

  2. 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.

    Time frame: Before and immediately after intervention

Secondary outcomes

  1. FCC feedback

    Semi-structured interview on the experience of the study participation

    Time frame: Immediately after intervention

  2. 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.

    Time frame: 4 weeks after intervention

  3. 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.

    Time frame: 4 weeks after intervention

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Study locations

1 site
  • Kessler Foundation
    West Orange, New Jersey 07052, United States
07

References and documents

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. PubMed 34196963 ↗
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Registry details

Key details

Study ID
NCT03402906
Lead sponsor
Kessler Foundation
Responsible party
Peii Chen (Senior Research Scientist, Kessler Foundation) — Principal investigator
First posted
Jan 18, 2018
Start date
Sep 30, 2017
Primary completion
Dec 31, 2024
Completion
Mar 31, 2025
Last update
Nov 25, 2025

Study contacts

Peii Chen, PhD
principal investigator · Kessler Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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