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NCT Number: NCT07741149

Self-Management Training 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • • 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.

Treatment and study plan

Participants will be referred to a community based self-management training program

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Quality of Life After Brain Injury

    Time frame: baseline, after the intervention on average 6 weeks

    This tool was developed to assess quality of life among individuals with traumatic brain injury

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Evans, PT, PhD

CONTACT

[email protected]

(617) 353 7493

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Official study title

Chronic Disease Self-Management Among Individuals With TBI

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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