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Clinical Trials/NCT07741149
NCT07741149Not yet recruitingNot Applicable

Chronic Disease Self-Management Among Individuals With TBI

Boston University Charles River Campus0 sites85 target enrollmentStarted: September 1, 2027Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
85
Primary Endpoint
PROMIS Self-Efficacy to Manage Chronic Disease Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

  • Quality of Life After Brain Injury(baseline, after the intervention on average 6 weeks)

Investigators

Sponsor
Boston University Charles River Campus
Sponsor Class
Other
Responsible Party
Sponsor

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