Clinical Trials Logo

Clinical Trial Summary

People who sustain moderate to severe traumatic brain injury (TBI) have an increased risk for unintentional injury and harm when resuming day to day activities in the home and community. People who sustain brain injuries primarily want to independently do the activities they enjoy while families primarily focus on avoiding injury or other harm events. Safe@Home is an injury prevention education and activity training program. Participants who have sustained a moderate or severe TBI receive a personalized strengths and safety risk assessment, tailored injury prevention education, and in-home training with a transition coach on self-selected activities. This study will evaluate whether the Safe@Home program reduces injuries and harm and increases clients' independence in their everyday activities in the home and community compared to a usual care control group.


Clinical Trial Description

Many persons who have sustained moderate to severe TBI and receive medical rehabilitation transition to their home and community settings with impaired cognition, perceptual motor skills, awareness of disability, self-regulation, and judgment that place them at risk for subsequent unintentional injury or harm. Unintentional injuries often result from falls; motor vehicle or pedestrian events; improper use of electrical equipment, fire, or sharp objects; poisonings; and firearm-related incidents. Risk for harm to self or others also results from victimization, loss of money or valuables, property damage, medication errors, inappropriate responses to emergency or medical situations, and self-regulation problems. Four TBI registry studies have shown that unintentional injury is a leading cause of death (18%-20%) in the year following discharge. In one study, 32% of TBI participants (n=504) had 228 ER visits/hospitalizations from 3-months to several years following discharge due to unintentional injuries.

In order to facilitate independent living and address the safety concerns for persons with TBI in the home and community, a targeted, self-management approach that includes injury prevention education and compensatory strategy training for instrumental activities of daily living (IADLs) is recommended. Institute of Medicine (IOM) and Agency for Healthcare Research and Quality (AHRQ) systematic reviews have recommended the need for TBI post-acute rehabilitation research to find efficient and effective independent living treatments for people with TBI. Rehabilitation investigators recommend evidence-based education that includes integrated, consensus-based, prevention strategies from multidisciplinary rehabilitation professionals to reduce unintentional injury and harm following TBI. Interventions should set goals important to the person with TBI, help the person and family to define roles/responsibilities and work as a team, and develop problem-solving skills and strategies.

The Safe@Home self-management intervention program builds upon our previous research on safety assessment and causes of unsafe events. This clinical trial will evaluate the effectiveness of a person and family-centered intervention to reduce unsafe events and increase self-managed activities and participation. The Safe@Home program is comprised of a personalized assessment report, prevention education and goal-setting, and in-home activity training with a life skills coach. The primary outcomes targeted for this intervention are to: 1) decrease unintentional injury and harm, i.e., unsafe events, and 2) increase independence in daily activities.

Participants will be assigned either to a usual care control group or the Safe@Home program group. Family members of both groups will be asked to complete assessments and both groups of participants and clients and family members will receive a personalized report on their strengths and risks, and suggested strategies to improve independence and reduce risk. The group receiving the Safe@Home Program will also receive in-home education on injury prevention and training on self-selected activities of interest.

Persons with TBI in the Safe@Home program will also be asked to:

- Participate in 2 education sessions to understand their strengths and risks, set goals, work as a team, reduce risks in their home, and problem-solve among themselves, their family member, and personal transition coach

- Participate in 8 in-home visits in which training and supports are provided to help with learning activity skills and compensatory strategies.

- Receive mobile phone and internet reminders to help work on goals and remember strategies.

- Complete a brief questionnaire that should take no longer than 15 minutes before the program, at the end of the program, and 3-months after the program ends.

The questionnaire will ask about:

- their current abilities

- their confidence in their ability to reach goals

- working with their family member on their activity goals and tasks

Family members play an important role in the transition from the hospital to home and have firsthand knowledge of the safety issues that each person with TBI faces.

Family members will be asked to:

- Participate in 2 education sessions to understand the person who had a brain injury strengths and risks, set goals, work as a team, reduce risks in the home, and problem-solve among themselves, their family member who had a brain injury, and personal transition coach

- Complete a questionnaire that should take no longer than 45 minutes to complete before the program, at the end of the program, and 3-months after the program ends.

- Complete a very brief report about unsafe events that should take no longer than 1-2 minutes to complete every 2 weeks.

This questionnaire will ask:

- general background and health information about the family member and the person with TBI

- the likelihood of certain unsafe situations occurring

- the supervision the person with TBI receives

- Mayo-Portland Participation subscale ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02893345
Study type Interventional
Source Shepherd Center, Atlanta GA
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 8, 2015
Completion date November 15, 2017

See also
  Status Clinical Trial Phase
Recruiting NCT03504709 - REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
Not yet recruiting NCT03648476 - Intervention to Change Attributions That Are Negative (ICAN) N/A
Completed NCT02426749 - Treatment and Recovery Monitoring of Post TBI Symptoms N/A
Completed NCT01339702 - The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Recruiting NCT03727737 - Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI N/A
Recruiting NCT03153397 - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial) N/A
Not yet recruiting NCT02776488 - Metabolic Therapy for Traumatic Brain Injury Phase 1/Phase 2
Recruiting NCT02004080 - CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Completed NCT01336413 - Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans Phase 2
Recruiting NCT03671083 - Validation of Brain Function Assessment Algorithm for mTBI From Initial Injury to Rehabilitation
Enrolling by invitation NCT02525432 - Autologous Stem Cell Study for Adult TBI (Phase 2b) Phase 2
Not yet recruiting NCT03429322 - Medical and Resource Facilitation Intervention After Traumatic Brain Injury N/A
Enrolling by invitation NCT02652598 - Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With BI and NCD Phase 2
Recruiting NCT03089749 - Characterization of Human Autoantibody Titers After Central Nervous System Insult
Active, not recruiting NCT02158494 - Noninvasive Neuromodulation for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury N/A
Active, not recruiting NCT01417468 - How Well do Patients With Traumatic Brain Injury Learn New Material Using Learning Styles in Online Science Classrooms? N/A
Terminated NCT00316004 - Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI) Phase 3
Recruiting NCT02920788 - Mild TBI Assessment & Rehabilitation N/A
Recruiting NCT03068143 - Postoperative Temperature Monitoring In Brain Trauma N/A
Completed NCT00961779 - Safety Study of NNZ-2566 in Healthy Female Subjects Phase 1