Traumatic Brain InjuryNCT03545594
Traumatic Brain Injury; Needs and Treatment Options in the Chronic Phase
A study testing Patient-centered in home rehabilitation in people with Traumatic Brain Injury, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Patient-centered in home rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Patient-centered in home rehabilitation, Control
- Keywords
- Randomized trial,, Health care needs, Traumatic brain injury, Community, Goal attainment
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-centered in home rehabilitationOther
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
ControlOther
Usual follow-up in the municipality
| Study group | Role | What they receive |
|---|---|---|
| Patient-centered in home rehabilitation | Experimental | 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: Receives: Other: Patient-centered in home rehabilitation |
| Control | Active comparator | Usual follow-up assessment and health care and rehabilitation services provided in the municipality Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation
Participation assessment and Recombined Tools- Objective (PART-O) (Social domain)
Measured: 12 months
General Health
Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )
Measured: 12 months
Secondary outcomes (12)
Global functioning
Glasgow outcome scale extended (GOSE) (score 0-8)
Measured: 4 and 12 months
Depression
Patients Health Questionnaire (PHQ-9) (patients and family members)
Measured: 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)
Measured: 4 and 12 months
Acceptability and satisfaction with the intervention
Acceptability Scale assessed by patients, care providers and family members (sum score)
Measured: 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.
Measured: 4 and 12 months
Symptom burden
Rivermead post-concussion questionnaire (RPQ)(patients) (scoring algoritm)
Measured: 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
Measured: 4 and 12 months
Caregiver burden (Caregiver burden scale)
Caregiver burden-family member
Measured: 4 and 12 months
Anxiety Disorder Measurement (GAD-7)
Generalised Anxiety Disorder Measurement (GAD-7) (sumscore 7 items, 0-21)
Measured: 4 and 12 months
Participation
Participation assessment and Recombined Tools- Objective (PART-O) (3 domains and total score
Measured: 4 months
General Health
Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )
Measured: 4 months
Participation
Participation assessment and Recombined Tools- Objective (PART-O) (domain Round and about and Productivity, Total score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Jun 2018
- Primary completion30 Apr 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnaas Rehabilitation Hospital, Virginia Commonwealth University
- Responsible party
- Principal investigator, Cecilie Røe, Oslo University Hospital
- Investigators
- Cecilie Røe, Study chair, OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545594
- Sponsor's protocol ID
- TBIcommunity
- Status last verified
- Mar 2022
- First submitted
- 9 May 2018
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated data will be shared according to the Norwegian legislation
Publications
Lovstad M, Borgen IMH, Hauger SL, Kleffelgard I, Brunborg C, Roe C, Soberg HL, Forslund MV. Family member reported symptom burden, predictors of caregiver burden and treatment effects in a goal-oriented community-based randomized controlled trial in the chronic phase of traumatic brain injury. BMC Neurol. 2024 Sep 10;24(1):333. doi: 10.1186/s12883-024-03841-7.
PubMed 39256658Kleffelgard I, Forslund M, Hauger S, Roe C, Bragstad LK, Soberg HL, Lovstad M, Borgen IMH. Process evaluation of a complex intervention evaluating the effectiveness of home-based rehabilitation in the chronic phase of traumatic brain injury. Disabil Rehabil. 2024 Dec;46(25):6134-6142. doi: 10.1080/09638288.2024.2324119. Epub 2024 Mar 6.
PubMed 38445314Borgen IMH, Lovstad M, Hauger SL, Forslund MV, Kleffelgard I, Andelic N, Sveen U, Soberg HL, Sigurdardottir S, Winter L, Lindstad MO, Brunborg C, Roe C. Effect of an Individually Tailored and Home-Based Intervention in the Chronic Phase of Traumatic Brain Injury: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2310821. doi: 10.1001/jamanetworkopen.2023.10821.
PubMed 37145600Borgen 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.
PubMed 32216840
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Brain Injury; Needs and Treatment Options in the Chronic Phase. A Randomized Controlled Community-based Intervention
- ClinicalTrials.gov ID
- NCT03545594
- Acronym / sponsor ID
- TBIcommunity
- Conditions
- Traumatic Brain Injury
- Keywords
- Randomized trial,, Health care needs, Traumatic brain injury, Community, Goal attainment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sunnaas Rehabilitation Hospital, Virginia Commonwealth University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Patient-centered in home rehabilitation | Experimental | Other: Patient-centered in home rehabilitationEight 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: |
| Control | Active comparator | Other: ControlUsual follow-up assessment and health care and rehabilitation services provided in the municipality |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-centered in home rehabilitationEight 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 | Other | Patient-centered in home rehabilitation |
| ControlUsual follow-up in the municipality | Other | Control |
Primary outcome
Participation
Time frame: 12 months
Participation assessment and Recombined Tools- Objective (PART-O) (Social domain)
General Health
Time frame: 12 months
Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )
12 secondary outcomes
Global functioning
Time frame: 4 and 12 months
Depression
Time frame: 4 months (patients and family) and 12 months intervention (patients)
Physical and mental health (EQ-5D) and quality-adjusted life years, (QALYs)
Time frame: 4 and 12 months
Acceptability and satisfaction with the intervention
Time frame: 4 and 12 months
Target outcome areas
Time frame: 4 and 12 months
Symptom burden
Time frame: 4 and 12 months
Patient and family members, evaluating self-awareness and functioning. Patient and family members, evaluating self-awareness and functioning
Time frame: 4 and 12 months
Caregiver burden (Caregiver burden scale)
Time frame: 4 and 12 months
Anxiety Disorder Measurement (GAD-7)
Time frame: 4 and 12 months
Participation
Time frame: 4 months
General Health
Time frame: 4 months
Participation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Derived from this study: PubMed 39256658Lovstad M, Borgen IMH, Hauger SL, Kleffelgard I, Brunborg C, Roe C, Soberg HL, Forslund MV. Family member reported symptom burden, predictors of caregiver burden and treatment effects in a goal-oriented community-based randomized controlled trial in the chronic phase of traumatic brain injury. BMC Neurol. 2024 Sep 10;24(1):333. doi: 10.1186/s12883-024-03841-7.
- Derived from this study: PubMed 38445314Kleffelgard I, Forslund M, Hauger S, Roe C, Bragstad LK, Soberg HL, Lovstad M, Borgen IMH. Process evaluation of a complex intervention evaluating the effectiveness of home-based rehabilitation in the chronic phase of traumatic brain injury. Disabil Rehabil. 2024 Dec;46(25):6134-6142. doi: 10.1080/09638288.2024.2324119. Epub 2024 Mar 6.
- Derived from this study: PubMed 37145600Borgen IMH, Lovstad M, Hauger SL, Forslund MV, Kleffelgard I, Andelic N, Sveen U, Soberg HL, Sigurdardottir S, Winter L, Lindstad MO, Brunborg C, Roe C. Effect of an Individually Tailored and Home-Based Intervention in the Chronic Phase of Traumatic Brain Injury: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2310821. doi: 10.1001/jamanetworkopen.2023.10821.
- Derived from this study: PubMed 32216840Borgen 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.
- Individual participant dataSharing planned: No. Only aggregated data will be shared according to the Norwegian legislation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilie Røe study chair
OUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-centered in home rehabilitation in people with Traumatic Brain Injury, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545594, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.