Traumatic Brain Injury; Needs and Treatment Options in the Chronic Phase

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Independent Outcome Assessor(s) blinded to the intervention arm by masking the ID and randomization arm on the assessment and outcome forms.

Study Groups

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Patient-centered in home rehabilitation

Eight contacts of about 2 hours duration each delivered over a 4-month period (Six in home visits and two telephone contacts before the Corona pandemic and adjusted to eight contacts and up to six of them video based when necessary during the Corona pandemic) in three phases:

Group Type EXPERIMENTAL

Patient-centered in home rehabilitation

Intervention Type OTHER

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

Control

Usual follow-up assessment and health care and rehabilitation services provided in the municipality

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Usual follow-up in the municipality

Interventions

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Patient-centered in home rehabilitation

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

Intervention Type OTHER

Control

Usual follow-up in the municipality

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No