Safe@Home: A Self-Management Program for Individuals With TBI and Their Families
Status unconfirmed · Phase 2
Conditions studied: Brain Injuries, Traumatic
In brief
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.
Key facts
- Study ID
- NCT02893345
- Run by
- Shepherd Center, Atlanta GA
- People needed
- 60
- Starts
- 2015-08-08
- Expected to finish
- 2017-11-15
- Last updated by the study team
- 2017-10-06
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Persons with TBI and family members will be eligible if they meet all of the following criteria:
- Person with TBI aged 18 or older who sustained moderate to severe TBI defined as externally caused damage to brain tissue as evidenced by one of the following (TBI Model Systems Criteria):
- Post-traumatic Amnesia (PTA) > 24 hours
- Trauma related intracranial neuroimaging abnormalities
- Loss of consciousness exceeding 30 minutes (and not due to sedation or intoxication)
- Glasgow Coma Scale (GCS) score in the emergency department of less than 13 (and not due to intubation, sedation, or intoxication)
- All participants must be capable of providing informed consent for research participation.
- Person with TBI has capacity to manage self-care as defined by a rehabilitation specialist rating the patient on the Mayo-Portland Self-Care item ≤ 2, i.e., requires a little assistance or supervision from others, ≤24% of the time.
- An adult family member, e.g., parent, spouse, adult child, or committed, domestic partner, aged 18 or older, living in the home environment is willing to participate.
- Person-family resides within 75 miles of the enrollment site and willing to allow a personal transition coach into the home.
- Person-family willing to use the internet or a mobile phone as part of the intervention.
- Person-family are English speaking, either native or English as a second language.
You may not qualify if…
- Person with brain injury primary diagnosis is hypoxic or hypoxic-ischemic (i.e., anoxic) brain injury; cerebral infarction (ischemic stroke) or cerebral hemorrhage (i.e., hemorrhagic stroke); intracranial hemorrhage (i.e., aneurismal rupture, subdural or epidural hematoma without TBI); inflammatory, toxic, or metabolic encephalopathies which are not complications of head trauma; seizure disorders (primary generalized epilepsy, partial epilepsies, status epilepticus, etc.); cerebral neoplasm; intracranial surgery; or condition other than moderate or severe TBI as defined above.
- Person with TBI could not self-manage activities prior to their injury due to severe, uncontrolled psychopathology (e.g., schizophrenia, bipolar disorder) or developmental disability.
- Person or family has current, severe, untreated/uncontrolled psychopathology (e.g., physically abusive, violent or sexual behavior) that places the personal transition coach treating in the home at physical risk.
- Person with TBI has severe, current physical or sensory impairment (e.g., tetraplegia, legally blind) that prohibits participation in all activity modules and reflects membership in a different population.
Where it is running
- Shepherd Center — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.