The primary objective is to evaluate the (cost)effectiveness and feasibility of case management after brain injury.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
niet aangeboren hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Secondary outcome
The 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 care needs (Longer-term Unmet
Needs after Stroke (LUNS)) and service use (care consumption list). 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)).
The feasibility will be evaluated using registration by caseamangers and
patients/caregivers.
The costeneffectiveness is measured with a specific costquestionnaire and the
EQ-5D-5L.
Background summary
In the Netherlands, approximately 650.000 people live with the consequences of
brain injury, affecting their participation and well-being. There are
sufficient services available to support people with learning how to live with
the consequences of brain injury. However, referral to such services is minimal
and patients/caregivers cannot find them on their own. Continuity of care is
currently lacking, hindering timely access to the appropriate services.
Study objective
The primary objective is to evaluate the (cost)effectiveness and feasibility of
case management after brain injury.
Study design
This is a randomized controlled study with repeated measures in patients with
brain injury, taking place between September 2019 and September 2020 in three
regions in the Netherlands. A group of brain injury patients and caregivers
will receive case management at discharge from the hospital, to explore the
(cost)effectiveness and feasibility of case management for brain injury
compared to the usual care
Intervention
The aim of case management after brain injury is to support patients* and
caregivers* self-management of the consequences of brain injury, to
improve/maintain psychosocial well-being, to prevent (escalation of) problems
and to facilitate timely access to appropriate services. The early inclusion
group will be entered into a digital monitoring system. When needs are
identified through the monitoring tool, the case manager gets in touch with the
patient/caregiver; the form and intensity of case management depend on their
individual needs, varying from providing information via telephone or email to
multiple contact moments, support in finding/accessing care services, etc.
Since the late inclusion group enters the study because they have a need for
help, they will be contacted by the case manager right away (i.e. not entered
in the monitoring tool first). Case management has no fixed frequency nor
duration.
Study burden and risks
There are no risks related to participation. Participants will fill out
questionnaires every six months for a duration of 18-24 months. Patients
receiving case management are expected to benefit from the monitoring of needs
and problems and getting support by the case manager.
Amendment: patients were informed they would receive questionnaires up to 18
months after baseline when they started after December 2019. Due to the
coronacrisis the subsiding party has extended the study period until December
2022. This provides us with the opportunity to assess all participants until 24
months after baseline. After T3, we will approach all participants who
indicated that they agree to be approached for future research on the original
consent form of the study. We will send them information on the extension and
the additional assessment at T4 (see appendix E1-3) and ask them to provide
written consent (see appendix E2-3). Those who fill out this consent form will
receive the questionnaires at T4
Universiteitsingel 40
Maastricht 6229 ER
NL
Universiteitsingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for patients:
* Acquired brain injury objectified by medical specialist (see appendix for
diagnosis and medical codes)
* Aged 18 years or older
* Living in the community prior to the injury
* Discharged home after hospital/rehabilitation
* Sufficient command of the Dutch language
* Access to a computer and the internet (monitoring tool and questionnaires)
* Willing and able to give informed consent
Exclusion criteria
A potential subject 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.
Design
Recruitment
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 |
---|---|
CCMO | NL70449.068.19 |
Other | NL7691 |