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ID
Source
Brief title
Health condition
Acquired brain injury
Sponsors and support
Intervention
Outcome measures
Primary outcome
The rate and timing of recovery of consciousness, using the Coma Recovery Scale-Revised. Furthermore the number and type of medical complications, including pain and mortality, patient’s level of disability, including the level of motor, cognitive, behavioural and emotional functioning, participation, and quality of life.
Secondary outcome
Secondary outcomes include self-efficacy of caregivers and caregivers’ strain and cost-effectiveness of the program.
Background summary
Rationale: Disorders of consciousness (DOC) occur after severe brain injury from various aetiologies. The states of DOC are coma, vegetative state (VS) or unresponsive wakefulness syndrome (UWS), and minimally conscious state (MCS). The outcomes of DOC in patients receiving early intensive rehabilitation (EIN) have been studied and showed that half to two thirds of patients with DOC regained consciousness at discharge. Furthermore, better outcomes in self-care, mobility, and cognition, and less complications have been observed in patients with DOC during intensive neurorehabilitation. However, long-term outcomes of DOC after EIN have not been studied systematically. From January 2019, EIN is insured standard care for all patients in the Netherlands (formerly only persons until 25 years had access to the programme), which is concentrated at Libra Rehabilitation & Audiology.
Objective: The aim of this study is to set up a registry and to systematically study the long-term outcomes of patients with DOC who receive EIN.
Study design: Single-centre prospective cohort study with a 2-year follow-up period. Measurements take place at start EIN, in week 5, 10, and at discharge of the EIN programme (duration = max 14 weeks) and at week 28, 40, 52, and 104.
Study population: Patients with DOC due to acute brain injury who receive EIN, aged 16 years and older.
Intervention (if applicable): Not applicable.
Main study parameters/endpoints: The rate and timing of recovery of consciousness, using the Coma Recovery Scale-Revised, the number and type of medical complications, including pain and mortality, patient’s level of disability, including the level of motor, cognitive, behavioural and emotional functioning, participation, and quality of life. Secondary outcomes include self-efficacy of caregivers and caregivers’ strain and cost-effectiveness of the program.
Study objective
Systematically study the long-term (2-years) outcomes of patients with DOC who receive EIN
Study design
5 years
Intervention
none
Inclusion criteria
• Age16 years or older.
• DOC (UWS or MCS) lasting > 2 weeks at admission and < 6 months
• First-time newly acquired non-progressive brain injury of any aetiology confirmed by neurological and /or neuroimaging data
• Weaned from ventilator
• Medically stable, as judged by the treating rehabilitation physician.
Exclusion criteria
• Coma
• Any pre-existent progressive or non-progressive brain injury
• Uncontrollable epilepsy
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8138 |
| Other | METC erasmus : MEC-2019-0127 |