Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
2019年4月11日 更新者：Douglas L. Weeks、St. Luke's Rehabilitation Institute
Each year over 12,000 spinal cord injuries (SCI) occur in the United States.
These injuries result in incredibly difficult, long-term, life adjustments both for patients and their caregivers.
Many families continue to struggle with the physical, emotional and social impacts of SCI for months and years after the injury.
Family education and support improves the outcomes of other challenging long-term conditions such as Traumatic Brain Injury, but little effort has been made to provide such interventions for persons with SCI and their caregivers.
The proposed study will address this problem by refining and testing a group treatment for SCI called Multi-family Group (MFG) intervention.
The groups will include people with SCI and their primary caregivers, and will be facilitated by an "educator" who is a health care provider who works with people with SCI.
By providing education about the management of SCI and support in an MFG format, quality of life for persons with SCI is predicted to be improved.
In turn, it is expected that caregivers will also benefit from the information, problem-solving activities, and social support that they receive from the educators and other group members.
The investigators will recruit 32 individuals with SCI who have been discharged from inpatient rehabilitation within the previous three years and their primary caregivers.
Participants will be randomized to the MFG intervention or to an education control condition and tested before and after treatment and 6 months following treatment.
It is hypothesized that participants receiving MFG-SCI will have better outcomes than controls on measures of quality of life, health, and adjustment.
The study will also test whether participants who are more recently discharged from inpatient rehabilitation will experience greater benefit from the MFG intervention or the education control intervention.
If the outcomes support the hypotheses, the MFG intervention should be made available to those with SCI and their caregivers.
研究概览
研究类型
介入性
注册 (实际的)
38
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Washington
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Spokane、Washington、美国、99202
- St. Luke's Rehabilitation Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- For Person with SCI: quadriplegia or paraplegia due to an acquired injury with complete or incomplete lesion as defined by ASIA
- For person with SCI: discharge from inpatient rehabilitation within the previous 3 years
- For Person with SCI: age 18 years or older
- For Person with SCI: mobility impairment as the result of the SCI
- For Person with SCI: living in the community in a non-group setting after injury
- For Person with SCI: planning to remain in the geographic area for at least 12 months
- For Person with SCI: competency in English
- For Caregiver of Person with SCI: provision of instrumental or emotional support for a spouse, relative, partner, or friend with SCI for at least the past 6 months
- For Caregiver of Person with SCI: having regular contact with the individual with SCI (at least a minimum of 2 hours face-to-face contact per week)
- For Caregiver of Person with SCI: living with or near the individual with SCI
- For Caregiver of Person with SCI: over the age of 18
- For Caregiver of Person with SCI: having a telephone
- For Caregiver of Person with SCI: planning to remain in the geographic area for at least 12 months
- For Caregiver of Person with SCI: competency in English
Exclusion Criteria:
- For Person with SCI or Caregiver: terminal illness with life expectancy of less than 12 months
- For Person with SCI or Caregiver: in active treatment for cancer
- For Person with SCI or Caregiver: blind or deaf
- For Person with SCI or Caregiver: moderate to severe cognitive impairment (defined at screening as a score on the Short Portable Mental Status Questionnaire > 4 errors)
- For Person with SCI or Caregiver: severely high level of depression symptoms (defined at screening as a score on the CES-D >30)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：SCI Education Control Group
The SCIEC condition is a 16-session, highly structured educational intervention that provides information on how SCI affects the body; methods for maximizing function, coping, and living with SCI; and staying healthy with SCI.
It also includes general guidelines for improving health behavior.
Each SCIEC session follows the same structure, beginning with a presentation of the objectives for the current session and a brief review of material from the previous session before introducing the session's topic and presenting information on one or two key problem areas.
SCIEC utilizes a traditional didactic model with information delivered by an expert SCI educator in a classroom or lecture setting.
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实验性的：Multi-family Group Treatment
The MFG Program uses a structured problem-solving and skills training program to provide participants with SCI and their caregivers with tools and information to improve coping and help family members to connect through positive behavioral exchanges.
MFG educators are health professionals with experience in management of SCI, such as physical therapists, recreational therapists, occupational therapists, and psychologists.
MFG will last for 16 sessions across 9 months.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in ability to take action to improve one's health from baseline to end of treatment
大体时间：9 months
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Ability to take action to improve one's health will be assessed with the Patient Activation Measure (PAM) and the 8-item Short-Form Health Survey (SF-8).
The PAM will measure the degree of individual's knowledge, confidence, and skill to participate in self-management.
A higher degree of patient activation has been associated with better health outcomes for adults with chronic conditions.
The SF-8 will assess self-reported general health, physical functioning, role-limitations due to physical health problems, bodily pain, and vitality.
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9 months
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Change in emotion regulation and interpersonal skills from baseline to end of treatment
大体时间：9 months
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Emotion regulation and interpersonal skills will be assessed with the Anger Expression Scale (AXS), the Abbreviated Duke Social Support Index (ADSSI), and the Family Crisis Oriented Personal Evaluation Scales (F-COPES).
The AXS measures anger management including anger-in (suppression of angry feelings), anger-out (expression of anger towards property or people) and anger control (the frequency of attempts to control expressions of anger).
The ADSSI measures both subjective support and social network interactions.
The F-COPES assesses family-level coping including use of social/spiritual support, reframing negative events, and mobilizing the family to acquire/accept help.
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9 months
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Change in mental health and health behavior from baseline to end of treatment
大体时间：9 months
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Mental health and health behavior will be assessed for the presence and severity of depressive symptoms, substance use, and in caregivers, burden of care, as these may influence benefits derived from treatment.
The 10-item Center for Epidemiologic Study of Depression (CESD-10) will measure depressive symptoms, and the Addiction Severity Index-Lite (ASI-L) will evaluate alcohol and substance use and related problems.
The Caregiver Burden Inventory (CBI) will evaluate caregiver burden in four areas: physical, social, emotional and time dependence burden.
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9 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in ability to take action to improve one's health from baseline to 6-months post-treatment
大体时间：15 months
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Ability to take action to improve one's health will be assessed with the Patient Activation Measure (PAM) and the 8-item Short-Form Health Survey (SF-8).
The PAM will measure the degree of individual's knowledge, confidence, and skill to participate in self-management.
A higher degree of patient activation has been associated with better health outcomes for adults with chronic conditions.
The SF-8 will assess self-reported general health, physical functioning, role-limitations due to physical health problems, bodily pain, and vitality.
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15 months
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Change in emotion regulation and interpersonal skills from baseline to 6-months post-treatment
大体时间：15 months
|
Emotion regulation and interpersonal skills will be assessed with the Anger Expression Scale (AXS), the Abbreviated Duke Social Support Index (ADSSI), and the Family Crisis Oriented Personal Evaluation Scales (F-COPES).
The AXS measures anger management including anger-in (suppression of angry feelings), anger-out (expression of anger towards property or people) and anger control (the frequency of attempts to control expressions of anger).
The ADSSI measures both subjective support and social network interactions.
The F-COPES assesses family-level coping including use of social/spiritual support, reframing negative events, and mobilizing the family to acquire/accept help.
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15 months
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Change in mental health and health behavior from baseline to 6-months post-treatment
大体时间：15 months
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Mental health and health behavior will be assessed for the presence and severity of depressive symptoms, substance use, and in caregivers, burden of care, as these may influence benefits derived from treatment.
The 10-item Center for Epidemiologic Study of Depression (CESD-10) will measure depressive symptoms, and the Addiction Severity Index-Lite (ASI-L) will evaluate alcohol and substance use and related problems.
The Caregiver Burden Inventory (CBI) will evaluate caregiver burden in four areas: physical, social, emotional and time dependence burden.
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15 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Dennis G. Dyck, PhD、Washington State University
- 首席研究员：Douglas L. Weeks, PhD、St. Luke's Rehabilitation Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Dyck DG, Weeks DL, Smith CL, Shaw M. Multiple family group intervention for spinal cord injury: Quantitative and qualitative comparison with standard education. J Spinal Cord Med. 2021 Jul;44(4):572-582. doi: 10.1080/10790268.2019.1710946. Epub 2020 Jan 21.
- Dyck DG, Weeks DL, Gross S, Lederhos Smith C, Lott HA, Wallace AJ, Wood SM. Comparison of two psycho-educational family group interventions for improving psycho-social outcomes in persons with spinal cord injury and their caregivers: a randomized-controlled trial of multi-family group intervention versus an active education control condition. BMC Psychol. 2016 Jul 26;4(1):40. doi: 10.1186/s40359-016-0145-0.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年9月1日
初级完成 (实际的)
2019年4月1日
研究完成 (实际的)
2019年4月1日
研究注册日期
首次提交
2014年6月6日
首先提交符合 QC 标准的
2014年6月10日
首次发布 (估计)
2014年6月12日
研究记录更新
最后更新发布 (实际的)
2019年4月16日
上次提交的符合 QC 标准的更新
2019年4月11日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
SCI Education Control Group的临床试验
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Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的肥胖 | 心血管危险因素 | 糖尿病风险