Brain Injuries, TraumaticPhase 2NCT02893345
Safe@Home: A Self-Management Program for Individuals With TBI and Their Families
A Phase 2 study testing Safe@Home Intervention Group in people with Brain Injuries, Traumatic, run by Shepherd Center, Atlanta GA at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Safe@Home Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2015to 15 Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safe@Home: A Self-Management Program for Individuals With Traumatic Brain Injury and Their Families
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.
Read the detailed 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
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Safe@Home Intervention Group, Usual Care Group
- Keywords
- Self Care (Rehabilitation), Community Participation, Patient-Centered Outcomes Research, Informatics, Clinical
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe@Home Intervention GroupBehavioural
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.
Usual Care GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline measure and post-intervention measure (~3-months post-baseline)
Secondary outcomes (4)
Change in Supervision Rating Scale Score
Amount of supervision provided by a family member on a 13 point scale
Measured: Baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline)
Change in Carrying Out Activities Scale Score
Measures level of safety risk associated with cognitive impairment using 17 items rated on a 4-point scale
Measured: Baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline)
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
Measured: From intervention conclusion to 3-months post-intervention
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
Measured: Baseline measure and 3-month post-intervention measure (6-months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start8 Aug 2015
- Primary completion15 Aug 2017
- Study completion15 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald T. Seel, PhD, Principal investigator, Shepherd Center, Atlanta GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893345
- Sponsor's protocol ID
- 627-605210-2
- Status last verified
- Sep 2017
- First submitted
- 25 Aug 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The principal investigator will ensure that all data sharing requirements of the funding agency are met. There is not a formal plan for sharing data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe@Home: A Self-Management Program for Individuals With Traumatic Brain Injury and Their Families
- ClinicalTrials.gov ID
- NCT02893345
- Acronym / sponsor ID
- 627-605210-2
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Self Care (Rehabilitation), Community Participation, Patient-Centered Outcomes Research, Informatics, Clinical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Study start
- 8 Aug 2015 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Nov 2017 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safe@Home Intervention Group | Experimental | Behavioral: Safe@Home Intervention GroupParticipants 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. |
| Usual Care Group | Active comparator | Other: Usual Care GroupParticipants receive the computer-generated, personalized assessment of abilities, risk, and recommended next steps. Participants may seek services as usual over the 3-month period. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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):
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe@Home Intervention GroupFor 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. | Behavioural | Safe@Home Intervention Group |
| Usual Care GroupPersons 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. | Other | Usual Care Group |
Primary outcome
Number of Unsafe Events for Each Participant
Time frame: From study start to intervention conclusion (~3-months)
Actual and near miss unsafe events including injury to self or others, and property damage or loss using a standardized survey
Change in Mayo-Portland Participation Scale Score
Time frame: Baseline measure and post-intervention measure (~3-months post-baseline)
Eight items in which amount and level of independence in activities is rated on a 5-point scale
4 secondary outcomes
Change in Supervision Rating Scale Score
Time frame: Baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline)
Change in Carrying Out Activities Scale Score
Time frame: Baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline)
Number of Unsafe Events for Each Participant
Time frame: From intervention conclusion to 3-months post-intervention
Change in Mayo-Portland Participation Scale Score
Time frame: Baseline measure and 3-month post-intervention measure (6-months post-baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Individual participant dataSharing planned: No. The principal investigator will ensure that all data sharing requirements of the funding agency are met. There is not a formal plan for sharing data at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald T. Seel, PhD principal investigator
Shepherd Center, Atlanta GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Safe@Home Intervention Group in people with Brain Injuries, Traumatic, run by Shepherd Center, Atlanta GA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Unsafe Events for Each Participant (time frame: From study start to intervention conclusion (~3-months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.