Systematically study the long-term (2-years) outcomes of patients with DOC who receive EIN
ID
Bron
Verkorte titel
Aandoening
Acquired brain injury
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Systematically study the long-term (2-years) outcomes of patients with DOC who receive EIN
Onderzoeksopzet
5 years
Onderzoeksproduct en/of interventie
none
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Coma
• Any pre-existent progressive or non-progressive brain injury
• Uncontrollable epilepsy
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8138 |
| Ander register | METC erasmus : MEC-2019-0127 |