Traumatic Brain Injury; Needs and Treatment Options in the Chronic Phase
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      Traumatic brain injury (TBI) is a condition affecting the persons' central nervous system
      with a need for extensive and highly specialized initial health care provision followed by
      comprehensive rehabilitation efforts. Frequent and life-long medical, cognitive, emotional
      and behavioral changes are expected. The community-based services are largely responsible for
      dealing with the chronic challenges affecting people with TBI.

      120 patients >16 years at the time of injury and between 18 and 72 years at inclusion, with
      clinical TBI diagnosis on acute admission and verified injury-related intracranial
      abnormalities reporting cognitive, emotional and physical problems more than 2 years after
      the injury will be included and randomized to a patient-centered in-home program intervention
      and treatment as usual. The intervention consists of an individualized and goal-oriented
      intervention will be provided in the persons' home environment, in close collaboration with
      family members and local health care providers when available. Assessments will be conducted
      at baseline, at the end of the intervention 4 months after inclusion and one year after
      inclusion. Primary outcome is participation (Part-O) and TBI specific health related quality
      of life (Qolibri). Secondary outcomes include goal attainment within individualized targeted
      outcome areas, depression and anxiety, symptom burden, unmet health care needs and
      acceptability of intervention as assessed by patient, family member and health professional.
      The project will contribute to increased understanding of knowledge transfer processes, and
      dissemination of evidence based practice for TBI. Thus, the project has the potential to
      improve the current health care for patients with TBI and its delivery.
    

Detailed description: 
      Traumatic brain injury (TBI) is a condition affecting the persons' central nervous system
      with a need for extensive and highly specialized initial health care provision followed by
      comprehensive rehabilitation efforts. Frequent and life-long medical, cognitive, emotional
      and behavioral changes are expected. The community-based services are largely responsible for
      dealing with the chronic challenges affecting people with TBI.

      120 patients >16 years at the time of injury and between 18 and 72 years at inclusion, with
      clinical TBI diagnosis on acute admission and verified injury-related intracranial
      abnormalities reporting cognitive, emotional and physical problems more than 2 years after
      the injury will be included and randomized to a patient-centered in-home program intervention
      and treatment as usual. The intervention consists of individualized and goal-oriented
      strategies provided in the persons' home environment in close collaboration with family
      members and local health care providers. The original protocol describes a total of 8
      sessions of which 2 will be telephone based. Due to the Corona pandemic hittting Norway in
      March 2020 the home visits had to be reduced and adapted to the individual situation of the
      participants. The protocol now includes 8 sessions with up to 6 of them being delivered by
      video. The intervention will be provided in addition to the usual treatment the participants
      receive in the municipality. The control group will receive the usual treatment provided in
      the municipality. Assessments will be conducted at baseline, at the end of the intervention
      4-5 months after inclusion and one year after inclusion. Primary outcome is participation
      (Part-O) and TBI specific health related quality of life (Qolibri). Secondary outcomes
      include goal attainment within individualized targeted outcome areas, depression and anxiety,
      symptom burden, unmet health care needs and acceptability of intervention as assessed by
      patient, family member and health professional. In March 2020 a few additional questions
      regarding the impact of the Corona pandemic on health and participation has been included.
      The closedown periods of the Norwegian Society during Covid-19 will be used as covariate
      and/or predictors in the analysis. The project will contribute to increased understanding of
      knowledge transfer processes, and dissemination of evidence based practice for TBI. Thus, the
      project has the potential to improve the current health care for patients with TBI and its
      delivery.
    

Intervention name(s): Patient-centered in home rehabilitation; Control
Intervention type(s): Other; Other
Intervention description(s): Eight contacts (six in-home visits of 1-2 hours duration each and two telephone contacts before the Corona pandemic and eight sessions with up to six of them video delivered if necessary during the Corona pandemic ) delivered over a 4-month period in three phases; Usual follow-up in the municipality
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Randomized trial,; Health care needs; Traumatic brain injury; Community; Goal attainment