Self-Management Training Among Individuals With TBI

Официальное название

Chronic Disease Self-Management Among Individuals With TBI

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• PROMIS Self-Efficacy to Manage Chronic Disease Scale [Срок оценки: baseline, after the intervention on average 6 weeks]

Вторичные конечные точки (1)

• Quality of Life After Brain Injury [Срок оценки: baseline, after the intervention on average 6 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07741149 · 8410E

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗