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临床试验/NCT04827095
NCT04827095Unknown不适用

Comparison of Two Web-Based Education/Support Programs for Partner Caregivers of People With Spinal Cord Injury

Kessler Foundation2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score

研究概览

简要总结

The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).

详细描述

SCI particularly affects partners (spouses or other types of significant others), as they face changes in relationship dynamics and identity as they take on a caregiver role. The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

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

  • At least 18 years old
  • Fluent in English (reading and writing)
  • Romanic partner of a person with SCI (regardless of martial status) for at least one year prior to injury
  • Live in a private residence with their partner with SCI
  • Partner is at least 3 months post discharge from inpatient rehabilitation
  • At least 6 months since their partner's injury
  • Provide care to their partner with SCI on a daily basis
  • Have access to the internet in a private location

排除标准

  • Participant reports a diagnosis of a schizoaffective disorder, bipolar personality disorder, or severe depression
  • History of hospitalization for depression treatment

结局指标

主要结局

Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score

时间窗: Average scores obtained during baseline (pre-program) compared to scores obtained immediately after program completion.

Change in behavior and emotion, measured by the Behavioral Inhibition/ Behavioral Activation Scale. The extent to which behavior and emotions change over time will be measured with the Behavioral Inhibition/ Behavioral Activation Scale. The BIS/BAS scale is composed of three subscales; (1) drive, which measures the persistent pursuit of goals, (2) fun seeking, which measures the desire for new rewards and the willingness to approach a potentially rewarding event, and (3) reward responsiveness, which measures positive responses to rewarding outcomes.

次要结局

  • Change in Marit-Meuser Caregiver Grief Inventory (CGI) scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in Zarit Burden Interview (ZBI) scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in NIH Toolbox Loneliness Survey (Fixed Form) scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in Connor-Davidson Resilience Scale scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in Couples Satisfaction Index scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in Satisfaction with Life Scale scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Changs in Duke Social Support Index (DSSI) scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Change in Patient Health Questionnaire scores(End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline)
  • Long-Term Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score(3-months post intervention versus baseline, 6-months post intervention versus baseline)

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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