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临床试验/CTRI/2026/01/100287
CTRI/2026/01/100287尚未招募3 期

Development and feasibility of a Contextualized Continuum of Care (CCoC)Model for Traumatic Brain Injury survivors

Manipal College of Health Professions1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年1月20日最近更新:

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

发起方
Manipal College of Health Professions
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DrMeghashree Sathish Nayak PT

Manipal College of Health Professions

研究点 (1)

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