Developing and testing a support model for people with head injury

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100287

Enrollment

Registered

2026-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S069- Unspecified intracranial injury

Interventions

Intervention1: Continuum of Care Intervention: The expected model includes structured discharge planning, caregiver training, simple home-based rehabilitation activities, referral pathway guidance, an

Eligibility

Inclusion criteria

Inclusion criteria: 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,

Exclusion criteria

Exclusion criteria: 1. 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. 2. 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.

Design outcomes

Primary

Measure	Time frame
Using the RE-AIM framework, we will assess the feasibility of the CCoC model across the following domains: Reach (proportion and characteristics of eligible participants enrolled), Effectiveness (participants improvement in quality of life will be assessed using secondary outcomes), Adoption (proportion of healthcare workers and caregivers who adopt proposed care components), Implementation (fidelity, adherence, and barriers during delivery), and Maintenance (sustainability and continued use of care components at follow-up).Timepoint: Baseline,2 weeks,1 month,2 months,3 months,4 months,5, and 6 months	—

Measure

Time frame

Using the RE-AIM framework, we will assess the feasibility of the CCoC model across the following domains: Reach (proportion and characteristics of eligible participants enrolled), Effectiveness (participants improvement in quality of life will be assessed using secondary outcomes), Adoption (proportion of healthcare workers and caregivers who adopt proposed care components), Implementation (fidelity, adherence, and barriers during delivery), and Maintenance (sustainability and continued use of care components at follow-up).Timepoint: Baseline,2 weeks,1 month,2 months,3 months,4 months,5, and 6 months

—

Secondary

Measure	Time frame
Quality of Life after Brain Injury (QOLIBRI) questionnaire Timepoint: Baseline,1, 3, and 6 months from the time of recruitment;DRS(Disability Rating Scale) Timepoint: Baseline, 1, 3, and 6 months from the time of recruitment;Traumatic Brain Injury Quality of Life (TBI-QoL)Timepoint: Baseline, 1, 3, and 6 months from the time of recruitment	—

Countries

India

Contacts

Public ContactDr Sunila John

Manipal College of Health Professions,MAHE,Manipal

john.solomon@manipal.edu9945670671

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026