| CTRI Number |
CTRI/2026/01/100287 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing and testing a support model for people with head injury |
|
Scientific Title of Study
|
Development and feasibility of a Contextualized Continuum of Care (CCoC)Model for Traumatic Brain Injury survivors |
| Trial Acronym |
CCoC-TBI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMeghashree Sathish Nayak PT |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Academy of Higher Education,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9113645784 |
| Fax |
|
| Email |
meghasree.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr John Solomon M |
| Designation |
Associate Dean and Professor |
| Affiliation |
Manipal College of Health Professions,MAHE,Manipal |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Academy of Higher Education,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945670671 |
| Fax |
|
| Email |
john.solomon@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunila John |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions,MAHE,Manipal |
| Address |
Department of Speech and Hearing,
Manipal College of Health Professions,
Manipal Academy of Higher Education,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986206894 |
| Fax |
|
| Email |
sunila.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital,Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy ,Manipal College of Health Professions, MAHE, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Meghashree Sathish Nayak |
Kasturba Hospital |
Dhanvantari Ward,
3rd floor,Kasturba Hospital
Uduipi-Hebri Road,Madhav Nagar,Manipal,Udupi 576104
Udupi
KARNATAKA |
9113645784
meghasree.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuum of Care Intervention |
The expected model includes structured discharge planning, caregiver training, simple home-based rehabilitation activities, referral pathway guidance, and timely follow-up. Context and available resources will also be considered. This will be applied to both the moderate and severe TBI survivors. There is no comparator agent as it is a single-arm feasibility study. |
| Comparator Agent |
Not applicable |
This is a single arm feasibility trial hence not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
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,
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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). |
Baseline,2 weeks,1 month,2 months,3 months,4 months,5, and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of Life after Brain Injury (QOLIBRI) questionnaire
|
Baseline,1, 3, and 6 months from the time of recruitment |
DRS(Disability Rating Scale)
|
Baseline, 1, 3, and 6 months from the time of recruitment |
| Traumatic Brain Injury Quality of Life (TBI-QoL) |
Baseline, 1, 3, and 6 months from the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |