Self-Management Training Among Individuals With TBI

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Participants will be referred to a community based self-management training program

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Evans, PT, PhD; Phone Number: (617) 353 7493; Email: eaevans@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-management training; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life After Brain Injury	This tool was developed to assess quality of life among individuals with traumatic brain injury	baseline, after the intervention on average 6 weeks

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Investigators: Principal Investigator: Emily Evans, PT, PhD, Boston University Charles River Campus

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: July 27, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 8410E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No