Development and feasibility of a Contextualized Continuum of Care (CCoC)Model for Traumatic Brain Injury survivors
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
The study has obtained ethical approvals from all institutional committees and will be registered under the Clinical Trials Registry of India. It follows a three-phase design: Phase 1 uses focus group discussions with healthcare professionals and semi-structured interviews with TBI survivors and caregivers to identify needs, barriers, and strategies for a Continuum of Care (CCoC) model. Phase 2 integrates these findings using a mixed-methods Delphi process and co-design workshops with experts, survivors, and caregivers to develop and refine CCoC model. Phase 3 evaluates the model’s feasibility through a longitudinal single-arm study involving 20 survivor–caregiver dyads (10 Moderate TBI survivors and their caregivers, and 10 severe TBI survivors and their caregivers) once they are medically stable in the hospital upto 6 months in community settings. Outcomes will be assessed using the RE-AIM framework, with structured follow-ups over six months. The study aims to produce practical, and contextually relevant continuum of care model for moderate to severe TBI survivors in LMIC settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Traumatic Brain Injury survivors of either gender, aged 18-64 years, 2.Diagnosed with TBI via CT /MRI showing intracranial abnormalities, 3.Moderate to severe TBI, defined by Glasgow Coma Scale (GCS) score of 3–12 at the time of hospital admission,.
排除标准
- •Individuals with severe pre-existing neurological disorders (e.g., stroke, epilepsy, neurodegenerative diseases) or major psychiatric illnesses (e.g., schizophrenia, bipolar disorder) diagnosed prior to TBI.
- •Individuals planned for discharge to inpatient rehabilitation centers, long-term care facilities, or other hospitals immediately after acute care.
- •3.Individuals with severe medical instability or comorbid conditions that would limit participation in the intervention.
- •4.Individuals not residing with a family caregiver or lacking caregiver support.
研究者
DrMeghashree Sathish Nayak PT
Manipal College of Health Professions
