Case management after acquired brain injury
- Conditions
- Acquired brain injury
- Registration Number
- NL-OMON26595
- Lead Sponsor
- Maastricht University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 86
In order to be eligible to participate in this study, patients must meet all of the following criteria:
? Acquired brain injury objectified by medical specialist
? Aged 18 years or older
? Living in the community prior to the injury
? Discharged home or to temporary care facility after hospital
? Sufficient command of the Dutch language
? Access to a computer and the internet
? Willing and able to give informed consent
Primary caregivers (the informal caregiver who takes primary responsibility to care for the person with brain injury) of eligible patients are eligible when they are aged 18 years or older, have sufficient command of the Dutch language, have access to a computer and internet and are willing and able to give informed consent. Primary caregivers can only participate if the person with brain injury is participating. If the patient does not have a primary caregiver or if the caregiver is not willing to participate, this will not be an exclusion criterion for the patient.
A potential participant will be excluded from participation in this study when they have degenerative disorders (e.g. Parkinson’s disease, dementia) because of the progressive course of the disease. Patients with a diagnosis related to neuro-oncology will be excluded as well, since an intensive care trajectory is already in place for these patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Hospital Anxiety and Depression Scale (HADS38) will be administered to assess symptoms of anxiety and depression. The scale consists of 14 items and two subscales (anxiety and depression). Scores >7 on a subscale suggest the presence of an anxiety disorder or depression. The psychometric quality of the scale is sufficient40.
- Secondary Outcome Measures
Name Time Method Effectiveness will be evaluated by assessment of self-management (Patient Activation Measure (PAM)), psychosocial well-being (Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) restriction subscale, the Life Satisfaction Questionnaire (LiSat) and the Hospital Anxiety and Depression Scale (HADS)), care needs (Longer-term Unmet Needs after Stroke (LUNS)). Caregiver outcomes include self-efficacy (Carer Self-Efficacy Scale (CSES)), caregiver burden (Caregiver Strain Index (CSI)), psychosocial well-being (LiSat, HADS), caregiver needs (Family Needs Questionnaire (FNQ)). Feasibility will be evaluated using qualitative methods, assessing fidelity, dose delivered, dose received, reach, recruitment and context. Cost-effectiveness will be determined by the EQ-5D-5L and service use (care consumption list).