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

Traumatic Brain Injury; Needs and Treatment Options in the Chronic Phase. A Randomized Controlled Community-based Intervention

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Control; Other: Patient-centered in home rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0407
    • OUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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:	Other: 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
Active Comparator: Control; Usual follow-up assessment and health care and rehabilitation services provided in the municipality	Other: Control; Usual follow-up in the municipality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation	Participation assessment and Recombined Tools- Objective (PART-O) (Social domain)	12 months
General Health	Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global functioning	Glasgow outcome scale extended (GOSE) (score 0-8)	4 and 12 months
Depression	Patients Health Questionnaire (PHQ-9) (patients and family members)	4 months (patients and family) and 12 months intervention (patients)
Physical and mental health (EQ-5D) and quality-adjusted life years, (QALYs)	Physical and mental health (scored according to the EQ-5D algoritm )and QALYs (patients) and overall health (on a scale 0-100,family members)	4 and 12 months
Acceptability and satisfaction with the intervention	Acceptability Scale assessed by patients, care providers and family members (sum score)	4 and 12 months
Target outcome areas	The patient nominate their three most important problems and the difficulties they have with them on a scale from 0 to 4. Changes in the difficulty score is evaluated.	4 and 12 months
Symptom burden	Rivermead post-concussion questionnaire (RPQ)(patients) (scoring algoritm)	4 and 12 months
Patient and family members, evaluating self-awareness and functioning. Patient and family members, evaluating self-awareness and functioning	Patient Competency Rating Scale (PCRS) (sum score) rated by patient and family member	4 and 12 months
Caregiver burden (Caregiver burden scale)	Caregiver burden-family member	4 and 12 months
Anxiety Disorder Measurement (GAD-7)	Generalised Anxiety Disorder Measurement (GAD-7) (sumscore 7 items, 0-21)	4 and 12 months
Participation	Participation assessment and Recombined Tools- Objective (PART-O) (3 domains and total score	4 months
General Health	Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )	4 months
Participation	Participation assessment and Recombined Tools- Objective (PART-O) (domain Round and about and Productivity, Total score	12 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Virginia Commonwealth University; Sunnaas Rehabilitation Hospital
• Investigators: Study Chair: Cecilie Røe, OUH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Community; Goal attainment; Randomized trial,; Health care needs
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: TBIcommunity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregated data will be shared according to the Norwegian legislation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No