The CONNECT Trial: A Randomized Pragmatic Clinical Trial Measuring the Effectiveness of a Remotely Provided Complex Brain Rehabilitation Intervention in Improving Participation Outcomes of Individuals With TBI, Their Families, and Local Primary Providers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 426
- 试验地点
- 2
- 主要终点
- Change in Traumatic Brain Injury - Quality of Life (TBI-QOL)
研究概览
简要总结
Mayo Clinic has been funded by the National Institute on Disability Independent Living & Rehabilitation Research (NIDILRR) as a Traumatic Brain Injury (TBI) Model System Center continuously since 1998. We have successfully competed for this funding because we consistently produce high quality research and because we provide comprehensive team-based rehabilitation services to people with TBI and their families over the continuum of care that is associated with superior outcomes.
Lack of access to specialized TBI care is the most common need identified by individuals after they are hospitalized for TBI. The upper Midwest has some of the highest populations of rural dwellers, the elderly, and Native Americans, all of whom have a high risk for TBI and are more likely to have limited access to rehabilitation services after acute care. Explosive advances in communication technology have brought tele-medicine to the forefront of health care. The CONNECT trial will test the effectiveness of using modern technologies - such as phone consultation and other telehealth communication systems - to deliver specialized brain rehabilitation resources remotely to patients and providers in the upper Midwest. The groups targeted by the CONNECT trial are:
- Individuals recently hospitalized with TBI;
- Their families;
- Their local health care and other providers (primary care providers, psychologists, therapists, social service providers, job counselors).
The CONNECT trial is the first study of this scope - in 4 upper Midwest states (MN, IA, ND, and SD), 3 health systems (Mayo Clinic, Altru Health System in ND, Regional Health in SD), and 2 state Departments of Health (IA, MN) - using electronic technology to see if outcome can be improved by providing care with no face-to-face contact. The trial will study whether outcomes over three years are different in the group receiving this remotely provided model of care compared to a matched group that receives usual care in their communities.
The desired long term outcome of this study is to increase our capacity to provide care and to reduce barriers to accessing specialized TBI rehabilitation services faced by individuals with TBI and their families.
详细描述
MAYO CLINIC TRAUMATIC BRAIN INJURY MODEL SYSTEM CENTER:
The CONNECT Trial
Connecting the upper Midwest traumatic brain injury community to Mayo Clinic and each other: providing research evidence of effectiveness for remote support and care coordination
Problem: Traumatic brain injury (TBI) is a common injury and cause of disability in the US, yet there are few medical practices specialized in treating post-acute and chronic impairment, activity limitations, and restrictions to community participation and employment that often result from TBI. This is of particular concern in rural areas, among the elderly, and in the Native American population.
Gap in knowledge: Evidence exists for the effectiveness of care provided by multi-discipline clinical rehabilitation teams in treating the complex medical, cognitive, and psychosocial sequelae of TBI and improving outcome. Some evidence exists for the effectiveness of remotely provided services, such as cognitive rehabilitation. Mayo Clinic's specialty brain rehabilitation practice has experience with assembling treatment teams in remote communities and providing clinical guidance, with positive anecdotal reports of effectiveness. However, there currently exists no research evidence indicating such intervention is superior to treatment as usual (TAU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •English speaking individuals who are at least 18 years old
- •Hospitalized for a minimum of 24 hours (no maximum) with TBI during the recruitment window in one of the following: 1) Hospital in state of Minnesota, 2) Hospital in state of Iowa, 3) Regional Health, 4) Altru Health System
- •Individuals with TBI who have (or their LAR has) at least telephone communication technology
排除标准
- •Non-English speaking individuals
- •Individuals under a civil commitment order
- •Individuals with TBI who are in coma or minimally conscious (not following commands)
研究组 & 干预措施
Complex clinical intervention
干预措施: Complex clinical intervention (Other)
Treatment as usual
干预措施: Treatment as usual (Other)
结局指标
主要结局
Change in Traumatic Brain Injury - Quality of Life (TBI-QOL)
时间窗: At enrollment, at 6 months, and at 18 months
TBI-QOL is a recently developed Computer Assisted Telephone Interview (CATI) tool that provides psychometrically sound and clinically relevant health-related patient-reported quality of life measurement specific to TBI. This scale is being used by the VA Research and Development Programs and will soon be a variable in the TBIMS National Database. TBI-QOL efficiently measures domains of depression, anxiety, fatigue and pain, using fewer items than scales measuring similar constructs. Responses for this scale will be obtained from subjects via a CATI.
Change in measure of patient impression of Telemedicine (TMP-Q)
时间窗: At enrollment, at 6 months, and at 18 months
Given that the entire complex intervention of this trial is delivered remotely, individual differences in its acceptance may influence outcome. The TMP-Q is a 17-item scale designed to assess impressions of the risks and benefits of home tele-care, and that has high levels of test-retest reliability and validity. Responses to a revised TMP-Q customized for the CONNECT trial will be obtained directly from subjects by phone interview or on-line via the protected and secure web-based CONNECT trial CareHubs site.
Change in Caregiver Appraisal Scale (CAS)
时间窗: At enrollment, at 6 months, and at 18 months
The CAS will be used only for family members or care givers to measure caregiver burden. It contains 4 measurable factors: Perceived Burden, Caregiver Satisfaction, Caregiver Idealogy and Caregiver Mastery. It includes 35 questions each measured on a 5-point Likert scale. The CAS has high internal consistency when used to study burden in those caring for individuals with TBI. Responses for this scale will be obtained from family members and caregivers via phone interview or on-line via the protected and secure web-based CONNECT trial CareHubs site.
Change in Clinical Satisfaction and Competency Rating (CSCR)
时间窗: At enrollment, at 6 months, and at 18 months
CSCR scales use a 5-point Likert method to measure satisfaction specific to individuals in each target population. They will be tested and refined in small groups of the target populations during Phase 1. The CSCR scale for individuals with TBI will focus on intervention quality, services, and progress. Satisfaction for family members will emphasize coping, communication, learning, and access. Questions to local providers will focus on their comfort, confidence, and competency in providing care to individuals with TBI. Responses for these scales will be obtained from individuals with TBI, their family members/caregivers, and their primary providers via phone interview or on-line via the protected and secure web-based CONNECT trial CareHubs site.
次要结局
- Change in the Activity Measure for Post-Acute Care™ (AM-PAC™)(At enrollment, at 6 months, and at 18 months)
- Change in self-reported use of health care and other community support services(Every 3 months after consenting until the end of study period at 18 months)