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

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ClinicalTrials.gov Identifier: NCT03545594
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : May 7, 2020
Sponsor:
Collaborators:
Sunnaas Rehabilitation Hospital
Virginia Commonwealth University
Information provided by (Responsible Party):
Cecilie Røe, Oslo University Hospital

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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Patient-centered in home rehabilitation Other: Control Not Applicable

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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Independent Outcome Assessor(s) blinded to the intervention arm by masking the ID and randomization arm on the assessment and outcome forms.
Primary Purpose: Supportive Care
Official Title: Traumatic Brain Injury; Needs and Treatment Options in the Chronic Phase. A Randomized Controlled Community-based Intervention
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Participation [ Time Frame: 12 months ]
    Participation assessment and Recombined Tools- Objective (PART-O) (3 domains and total score

  2. General Health [ Time Frame: 12 months ]
    Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )


Secondary Outcome Measures :
  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 )



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545594


Contacts
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Contact: Cecilie Røe, PhD +4792868388 cecilie.roe@ous-hf.no
Contact: Marit Forslund marit.forslund@ous-hf.no

Locations
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Norway
OUH Recruiting
Oslo, Norway, 0407
Contact: Cecilie Røe, PhD         
Sub-Investigator: Ida Borgen, Msc         
Sub-Investigator: Marit Forslund, PhD         
Sub-Investigator: Ingerid Kleffelgård, PhD         
Sub-Investigator: Solveig Hauger, PhD         
Principal Investigator: Cecilie Røe, PhD         
Sponsors and Collaborators
Oslo University Hospital
Sunnaas Rehabilitation Hospital
Virginia Commonwealth University
Investigators
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Study Chair: Cecilie Røe OUH
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cecilie Røe, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03545594    
Other Study ID Numbers: TBIcommunity
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregated data will be shared according to the Norwegian legislation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cecilie Røe, Oslo University Hospital:
Randomized trial,
Health care needs
Traumatic brain injury
Community
Goal attainment
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System