Clinical trial NCT03545594: Traumatic Brain Injury; Needs and Treatment Options in the Chronic Phase
Official title: Traumatic Brain Injury; Needs and Treatment Options in the Chronic Phase. A Randomized Controlled Community-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Randomized trial,
Health care needs
Traumatic brain injury
Community
Goal attainment
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sunnaas Rehabilitation Hospital
name: Virginia Commonwealth University
First posted: 2018-06-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients \>16 years at injury and 18-72 years at inclusion, with clinical TBI diagnosis on acute admission and CT/MRI verified injury-related intracranial abnormalities.
* Patients reporting TBI-related cognitive, emotional and physical problems and/or reduced physical and mental health and/or difficulties with participation in activities with family, friends and in the community at least 2 years after the injury,
* Able to provide informed consent and collaborate in the goal setting processing.
* Living at home at study inclusion.

Exclusion Criteria:

* Patients are excluded if they have severe preexisting neurological disorder that would confound outcome assessments and severe psychiatric diseases
* Patients unable to provide informed consent or participate in a goal-setting process.
* Participants with insufficient fluency in Norwegian to allow for communication with therapists and outcome assessors will also be excluded.
* Substance abuce or history of violence that could represent a security risk for the professionals delivering the intervention

Primary outcomes:
measure: Participation
timeFrame: 12 months
measure: General Health
timeFrame: 12 months
Secondary outcomes:
measure: Global functioning
timeFrame: 4 and 12 months
measure: Depression
timeFrame: 4 months (patients and family) and 12 months intervention (patients)
measure: Physical and mental health (EQ-5D) and quality-adjusted life years, (QALYs)
timeFrame: 4 and 12 months
measure: Acceptability and satisfaction with the intervention
timeFrame: 4 and 12 months
measure: Target outcome areas
timeFrame: 4 and 12 months
measure: Symptom burden
timeFrame: 4 and 12 months
measure: Patient and family members, evaluating self-awareness and functioning. Patient and family members, evaluating self-awareness and functioning
timeFrame: 4 and 12 months
measure: Caregiver burden (Caregiver burden scale)
timeFrame: 4 and 12 months
measure: Anxiety Disorder Measurement (GAD-7)
timeFrame: 4 and 12 months
measure: Participation
timeFrame: 4 months
measure: General Health
timeFrame: 4 months
measure: Participation
timeFrame: 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: OUH
Study officials:
affiliation: OUH
name: Cecilie Røe
role: STUDY_CHAIR
References:
citation: Borgen IMH, Lovstad M, Andelic N, Hauger S, Sigurdardottir S, Soberg HL, Sveen U, Forslund MV, Kleffelgard I, Lindstad MO, Winter L, Roe C. Traumatic brain injury-needs and treatment options in the chronic phase: Study protocol for a randomized controlled community-based intervention. Trials. 2020 Mar 27;21(1):294. doi: 10.1186/s13063-020-4195-5.