Self-Management Training Among Individuals With TBI

NCT07741149 | Not Yet Recruiting

• 1 other identifier: 8410E
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, after the intervention on average 6 weeks

Secondary Outcomes (1)

• Quality of Life After Brain Injury

  baseline, after the intervention on average 6 weeks

Study Arms (1)

Self-management training

EXPERIMENTAL

Individuals enrolled in this arm will participate in a community-based self management training program

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

Interventions

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.

Self-management training

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University Charles River Campus: lead

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

• Emily Evans, PT, PhD

  Boston University Charles River Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Evans, PT, PhD

CONTACT

(617) 353 7493; eaevans@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share