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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545594
• Other study ID #: TBIcommunity
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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
• Control
Usual follow-up in the municipality

Locations

Country	Name	City	State
Norway	OUH	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Sunnaas Rehabilitation Hospital, Virginia Commonwealth University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation	Participation assessment and Recombined Tools- Objective (PART-O) (Social domain)	12 months
Primary	General Health	Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )	12 months
Secondary	Global functioning	Glasgow outcome scale extended (GOSE) (score 0-8)	4 and 12 months
Secondary	Depression	Patients Health Questionnaire (PHQ-9) (patients and family members)	4 months (patients and family) and 12 months intervention (patients)
Secondary	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
Secondary	Acceptability and satisfaction with the intervention	Acceptability Scale assessed by patients, care providers and family members (sum score)	4 and 12 months
Secondary	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
Secondary	Symptom burden	Rivermead post-concussion questionnaire (RPQ)(patients) (scoring algoritm)	4 and 12 months
Secondary	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
Secondary	Caregiver burden (Caregiver burden scale)	Caregiver burden-family member	4 and 12 months
Secondary	Anxiety Disorder Measurement (GAD-7)	Generalised Anxiety Disorder Measurement (GAD-7) (sumscore 7 items, 0-21)	4 and 12 months
Secondary	Participation	Participation assessment and Recombined Tools- Objective (PART-O) (3 domains and total score	4 months
Secondary	General Health	Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )	4 months
Secondary	Participation	Participation assessment and Recombined Tools- Objective (PART-O) (domain Round and about and Productivity, Total score	12 months