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Completed

NCT Number: NCT03545594

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

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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Key information

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OUH

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-centered in home rehabilitation

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

Other

Usual follow-up in the municipality

Primary outcomes

  1. Participation

    Time frame: 12 months

    Participation assessment and Recombined Tools- Objective (PART-O) (Social domain)

  2. General Health

    Time frame: 12 months

    Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )

Secondary outcomes

  1. Global functioning

    Time frame: 4 and 12 months

    Glasgow outcome scale extended (GOSE) (score 0-8)

  2. Depression

    Time frame: 4 months (patients and family) and 12 months intervention (patients)

    Patients Health Questionnaire (PHQ-9) (patients and family members)

  3. Physical and mental health (EQ-5D) and quality-adjusted life years, (QALYs)

    Time frame: 4 and 12 months

    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. Acceptability and satisfaction with the intervention

    Time frame: 4 and 12 months

    Acceptability Scale assessed by patients, care providers and family members (sum score)

  5. Target outcome areas

    Time frame: 4 and 12 months

    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.

  6. Symptom burden

    Time frame: 4 and 12 months

    Rivermead post-concussion questionnaire (RPQ)(patients) (scoring algoritm)

  7. Patient and family members, evaluating self-awareness and functioning. Patient and family members, evaluating self-awareness and functioning

    Time frame: 4 and 12 months

    Patient Competency Rating Scale (PCRS) (sum score) rated by patient and family member

  8. Caregiver burden (Caregiver burden scale)

    Time frame: 4 and 12 months

    Caregiver burden-family member

  9. Anxiety Disorder Measurement (GAD-7)

    Time frame: 4 and 12 months

    Generalised Anxiety Disorder Measurement (GAD-7) (sumscore 7 items, 0-21)

  10. Participation

    Time frame: 4 months

    Participation assessment and Recombined Tools- Objective (PART-O) (3 domains and total score

  11. General Health

    Time frame: 4 months

    Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )

  12. Participation

    Time frame: 12 months

    Participation assessment and Recombined Tools- Objective (PART-O) (domain Round and about and Productivity, Total score

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Sunnaas Rehabilitation Hospital
  • Virginia Commonwealth University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2018
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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