跳至主要内容
临床试验/NCT03402906
NCT03402906终止不适用

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

Kessler Foundation1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2017年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
14
试验地点
1
主要终点
Spatial neglect assessment battery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Family-Clinician Collaboration

Experimental

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.

干预措施: Family-Clinician Collaboration Program (Behavioral)

结局指标

主要结局

Spatial neglect assessment battery

时间窗: 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

时间窗: 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.

次要结局

  • Family caregiver wellness(4 weeks after intervention)
  • Spatial neglect assessment battery(4 weeks after intervention)
  • FCC feedback(Immediately after intervention)

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peii Chen

Senior Research Scientist

Kessler Foundation

研究点 (1)

Loading locations...

相似试验