Traumatic Brain InjuryNCT07741149
Self-Management Training Among Individuals With TBI
A study testing Participants will be referred to a community based self-management training program in people with Traumatic Brain Injury, run by Boston University Charles River Campus.
Trial summary
Traumatic brain injury (TBI) can have long-term and chronic effects on an individual's physical, social, and emotional health, impacting quality of life and the ability to engage in meaningful life roles. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Participants will be referred to a community based self-management training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Sep 2027to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years at time of first TBI
- At least one year since the most recent TBI
- Received care at BMC's Concussion/TBI program for a TBI or concussion
- At least partially involved in Self-care
- Able to provide consent
- Able to speak and understand English
- Available for study duration.
Who cannot join
- • Aged <18 at the time of their first TBI
- Severe mental, cognitive, social, or emotional difficulties due to another neurologic, developmental, psychological condition, or active substance use disorder
- Participating in another interventional clinical trial
- Planned major surgery in the next 4 months.
- Pregnancy (self-report).
- Suspected or known drugs or alcohol abuse
- Endorses suicidal ideation
- All individuals with reduced decision-making capacity, an assigned LAR, or conservator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chronic Disease Self-Management Among Individuals With TBI
Traumatic brain injury (TBI) can have long-term and chronic effects on an individual's physical, social, and emotional health, impacting quality of life and the ability to engage in meaningful life roles. Despite the potential for long-term effects, much of the care for individuals with TBI is front-loaded in the weeks to months post-injury. Self-management and self-management training are key components of long-term care for many chronic health conditions, but they are not standard parts of care for individuals with TBI.
In this study the investigators will address two objectives: 1) identify self-management priorities from the perspectives of individuals with chronic TBI, families, and health care providers and 2) pilot test an existing virtual community-based self-management training program (the Chronic Disease Self-Management Program (CDMSP)), to a) evaluate changes in quality of life, self-management self-efficacy, and other patient-reported outcomes before and after participating in the training, and b) identify barriers and facilitators to participating in community-based self-management training.
- Conditions
- Traumatic Brain Injury
- Being tested
- Participants will be referred to a community based self-management training program
- 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.
Participants will be referred to a community based self-management training programBehavioural
Individuals will participate in a 6-week group training course run by a community-based organization that provides training in self-management skills for individuals with chronic health conditions.
| Study group | Role | What they receive |
|---|---|---|
| Self-management training | Experimental | Individuals enrolled in this arm will participate in a community-based self management training program Receives: Behavioral: Participants will be referred to a community based self-management training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Self-Efficacy to Manage Chronic Disease Scale
A patient reported outcome measure that assesses self-efficacy to managing chronic disease across 5 domains: Managing: Symptoms, Social Interactions, Medications, Emotions, and Daily Activities
Measured: baseline, after the intervention on average 6 weeks
Secondary outcomes (1)
Quality of Life After Brain Injury
This tool was developed to assess quality of life among individuals with traumatic brain injury
Measured: baseline, after the intervention on average 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startSep 2027 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Evans, PT, PhD, Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741149
- Sponsor's protocol ID
- 8410E
- Status last verified
- Feb 2026
- First submitted
- 19 Mar 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Disease Self-Management Among Individuals With TBI
- ClinicalTrials.gov ID
- NCT07741149
- Acronym / sponsor ID
- 8410E
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- Sep 2027 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 3 Aug 2026 (actual)
- 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.
Traumatic brain injury (TBI) can have long-term and chronic effects on an individual's physical, social, and emotional health, impacting quality of life and the ability to engage in meaningful life roles. Despite the potential for long-term effects, much of the care for individuals with TBI is front-loaded in the weeks to months post-injury. Self-management and self-management training are key components of long-term care for many chronic health conditions, but they are not standard parts of care for individuals with TBI.
In this study the investigators will address two objectives: 1) identify self-management priorities from the perspectives of individuals with chronic TBI, families, and health care providers and 2) pilot test an existing virtual community-based self-management training program (the Chronic Disease Self-Management Program (CDMSP)), to a) evaluate changes in quality of life, self-management self-efficacy, and other patient-reported outcomes before and after participating in the training, and b) identify barriers and facilitators to participating in community-based self-management training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-management training | Experimental | Behavioral: Participants will be referred to a community based self-management training programIndividuals enrolled in this arm will participate in a community-based self management training program |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years at time of first TBI
- At least one year since the most recent TBI
- Received care at BMC's Concussion/TBI program for a TBI or concussion
- At least partially involved in Self-care
- Able to provide consent
Key exclusion criteria (8 listed)
- • Aged <18 at the time of their first TBI
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 |
|---|---|---|
| Participants will be referred to a community based self-management training programIndividuals will participate in a 6-week group training course run by a community-based organization that provides training in self-management skills for individuals with chronic health conditions. | Behavioural | Self-management training |
Primary outcome
PROMIS Self-Efficacy to Manage Chronic Disease Scale
Time frame: baseline, after the intervention on average 6 weeks
A patient reported outcome measure that assesses self-efficacy to managing chronic disease across 5 domains: Managing: Symptoms, Social Interactions, Medications, Emotions, and Daily Activities
1 secondary outcome
Quality of Life After Brain Injury
Time frame: baseline, after the intervention on average 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Emily Evans, PT, PhD principal investigator
Boston University Charles River Campus
Questions about this trial
What is this clinical trial studying?
A study testing Participants will be referred to a community based self-management training program in people with Traumatic Brain Injury, run by Boston University Charles River Campus.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Evans, PT, PhD ((617) 353 7493, eaevans@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Self-Efficacy to Manage Chronic Disease Scale (time frame: baseline, after the intervention on average 6 weeks). 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 3 Aug 2026.