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临床试验/NCT04019275
NCT04019275终止不适用

ENGAGE Pilot Study: Promoting Participation and Health After Stroke

University of Pittsburgh6 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年9月1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
入组人数
38
试验地点
6
主要终点
Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist

研究概览

简要总结

This is a multi-site single-arm community-based pilot study examining the feasibility, acceptability, safety, and estimated effects of the ENGAGE intervention, a community-based intervention to promote community participation after stroke. The study will also characterize variances in changes in community participation outcomes. These findings will provide the pilot data needed to inform a multi-site randomized controlled clinical trial.

详细描述

Significant advancements in acute medical management have shifted stroke from an acute condition with a high prevalence of mortality to a chronic condition with high prevalence of morbidity. One of the leading causes of chronic illness and disability worldwide, stroke results in residual sensorimotor, cognition, and communication impairments. These impairments reduce over time, but few people have complete restoration of function. Hence, people with stroke-related disability do not resume pre-stroke levels of community participation (education; paid or volunteer work; civic, social, and religious activities; and leisure). Low levels of community participation are associated with inactivity, sedentary behavior, and social isolation, each contributors to cardiovascular disease, diabetes, obesity, pulmonary conditions, depression - and secondary stroke. These consequences are particularly problematic for people with low income who have limited resources.

Investigators at the University of Pittsburgh, Washington University, and the University of Illinois at Chicago have designed a self-management training program that uses social learning, motivational interviewing, and guided discovery to help people with mild to moderate stroke-related disability resume community participation, and to develop a strong network of social support. However, the combination of these elements has yet to be studied in people with chronic stroke-related disability who live with low income - one of the most vulnerable segments of the population. By partnering with the Community Research Fellows Program at Washington University and the Community PARTners Program at the University of Pittsburgh, this multi-site team seeks to design and implement a culturally-responsive program to promote community participation among people with stroke-related disability and low income. This new collaboration is the next logical step in the development and examination of community-based interventions to promote self-management and community participation after stroke.

The overall purpose of this research study is to examine the feasibility, safety, and acceptability of a multi-site community-based intervention to promote self-management of community participation after stroke, with a particular focus on the needs of people with low income. The study will also characterize variances in intervention response.

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

入选标准

  • ages 18 and older
  • chronic stroke (minimum 3 months)
  • community-dwelling
  • mild to moderate stroke-related disability (NIHSS<=16)
  • restrictions in community participation (ACS <80% of pre-stroke activities)
  • low income (uninsured or underinsured)
  • able to provide written informed consent

排除标准

  • currently receiving rehabilitation serves
  • dementia diagnosis
  • severe aphasia (BDAE=0 or 1)
  • current major depressive disorder (unless treated and in partial remission)
  • current bipolar or psychotic disorder
  • substance abuse within 3 months

研究组 & 干预措施

ENGAGE

Experimental

The intervention blends social learning, guided discovery, and skill training to promote community participation after stroke. The intervention is delivered in a group format and comprises group learning activities and individual action planning activities that address barriers to community participation after stroke.

干预措施: ENGAGE (Behavioral)

结局指标

主要结局

Fidelity, Indicated by Score of 18 or Higher Out of 20 on the ENGAGE Fidelity Checklist

时间窗: week 7

number of sessions attaining \>= 90% adherence to protocol; an independent evaluator will assess a random 20% of sessions using the ENGAGE Fidelity Checklist; the Checklist has 20 items, each rated as 2=exceptional, 1=adherent, 0=not adherent

Acceptability, Indicated by Score 24 or Higher Out of 32 on the Client Satisfaction Questionnaire

时间窗: week 7

Number of participants attaining \>= 90% satisfaction; satisfaction is rated on 8 items with a 4-point Likert-type scale, 4 indicating very high satisfaction. Items are summed with total score ranging from 8 indicating poor satisfaction to 32 indicating very high satisfaction.

Adverse Events, Defined as Reported Injuries or Injurious Falls

时间窗: week 7

次要结局

  • Cohen's d Effect Size of the Change From Week 1 to Week 7 in PROMIS Ability to Participate in Social Roles(week 1 vs week 7)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth R. Skidmore, PhD, OTR/L

Professor, Occupational Therapy

University of Pittsburgh

研究点 (6)

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