Safe@Home: A Self-Management Program for Individuals With TBI and Their Families

NCT02893345 | Unknown Phase 2

• 1 other identifier: 627-605210-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Injuries, Traumatic

Keywords

Self Care (Rehabilitation); Community Participation; Patient-Centered Outcomes Research; Informatics, Clinical

Outcome Measures

Primary Outcomes (2)

• Number of Unsafe Events for Each Participant

  Actual and near miss unsafe events including injury to self or others, and property damage or loss using a standardized survey

  From study start to intervention conclusion (~3-months)

• Change in Mayo-Portland Participation Scale Score

  Eight items in which amount and level of independence in activities is rated on a 5-point scale

  Baseline measure and post-intervention measure (~3-months post-baseline)

Secondary Outcomes (4)

• Change in Supervision Rating Scale Score

  Baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline)

• Change in Carrying Out Activities Scale Score

  Baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline)

• Number of Unsafe Events for Each Participant

  From intervention conclusion to 3-months post-intervention

• Change in Mayo-Portland Participation Scale Score

  Baseline measure and 3-month post-intervention measure (6-months post-baseline)

Study Arms (2)

Safe@Home Intervention Group

EXPERIMENTAL

Participants receive: (1) computer-generated, personalized assessment of abilities, risk, and recommended next steps; (2) 2 person-family education visits to develop a shared understanding of client strengths and risks, set goals, develop better ways to work as a team, and problem-solve; (3) 8 in-home visits in which personal transition trainer/life skills coach provides training, compensatory strategies, and social/technological supports on self-selected activities. The ten visits last 90-120 minutes and ideally take place over a three month period.

Behavioral: Safe@Home Intervention Group

Usual Care Group

ACTIVE COMPARATOR

Participants receive the computer-generated, personalized assessment of abilities, risk, and recommended next steps. Participants may seek services as usual over the 3-month period.

Other: Usual Care Group

Interventions

Safe@Home Intervention Group BEHAVIORAL

For the 8 training visits, participants may select to work on skills in 2 of 5 activity modules: Improving mobility, balance and strength; Managing health and wellness; Staying On Your Own at Home; Maintaining the home; Getting out in the community. Participants may seek single service rehabilitation, medical, and psychological care as usual.

Safe@Home Intervention Group

Usual Care Group OTHER

Persons can set goals and work on activities with or without a family member as they so choose. Participants may seek single service rehabilitation, medical, and psychological care as usual.

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead

Study Sites (1)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ronald T. Seel, PhD

  Shepherd Center, Atlanta GA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 8, 2016
• Study Start: August 8, 2015
• Primary Completion: August 15, 2017
• Study Completion: November 15, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)