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Not yet recruiting NCT07741149

Self-Management Training Among Individuals With TBI

No phase Interventional Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Participants will be referred to a community based self-management training program.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Chronic Disease Self-Management Among Individuals With TBI

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • PROMIS Self-Efficacy to Manage Chronic Disease Scale [Time frame: baseline, after the intervention on average 6 weeks]
Secondary outcome measures (1)
  • Quality of Life After Brain Injury [Time frame: baseline, after the intervention on average 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07741149 · 8410E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗