Brain InjuriesTBI-CERNCT02646176
Comparative Effectiveness of Rehabilitation Interventions for Traumatic Brain Injury
An observational study of Brain Injuries, run by Jennifer Bogner, PhD, ABPP.
Trial summary
Traumatic brain injury (TBI) is increasingly recognized as a significant public health issue, but the most effective rehabilitation methods have yet to be identified. The Institute of Medicine and the Agency for Healthcare Quality and Research sponsored systematic reviews of evidence for comparative effectiveness of… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Inpatient rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,130 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Oct 2012
- Phase
- Observational
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study sample was drawn from the population of persons who received inpatient rehabilitation for TBI in North America.
Who may be able to join
- Sustained a TBI, defined as damage to brain tissue caused by external force and evidenced by loss of consciousness, post-traumatic amnesia, skull fracture, or objective neurological findings
- Diagnosed with an International Classification of Diseases (ICD-9-CM) code consistent with the CDC Guidelines for Surveillance of Central Nervous System Injury
- Receiving inpatient care on a designated brain injury rehabilitation unit of one of the participating rehabilitation facilities
- Incurred a TBI severe enough to warrant inpatient rehabilitation regardless of other injuries, with TBI being the predominant reason for rehabilitation admission
Who cannot join
- 1. None
About this study
Traumatic brain injury (TBI) is increasingly recognized as a significant public health issue, but the most effective rehabilitation methods have yet to be identified. The Institute of Medicine and the Agency for Healthcare Quality and Research sponsored systematic reviews of evidence for comparative effectiveness of rehabilitation interventions for TBI. Both reviews concluded that substantially more research is needed to identify interventions best suited for different individuals. The practice-based evidence (PBE) approach employed to create the data used in the proposed study was a research method recommended to provide greater clarity, along with use of patient-centered outcomes obtained over a longer period of time than used in previous studies.
The following specific aims will be addressed in the proposed study:
Read more
- Determine the comparative effectiveness of different therapeutic approaches used in inpatient TBI rehabilitation after statistically adjusting for patient need and ability to benefit from various approaches. Investigators hypothesize: 1.1. Patients who receive a greater proportion of therapy time in Advanced Training (versus Standard of Care) will achieve better outcomes than similar patients who receive a lesser proportion of treatment time in Advanced Training. 1.2. Patients with the greatest initial levels of disability will experience larger effects from Advanced Training therapeutic approaches in comparison to the effects experienced by patients with less disability at admission. 1.3. Patients who receive a greater proportion of therapy in contextualized treatment (versus decontextualized) will achieve better outcomes than similar patients who receive a lesser proportion of time in contextualized treatment.
- Determine the comparative effectiveness of difference in the delivery of inpatient rehabilitation therapies, after statistically adjusting for patient need and ability to benefit.
Investigators hypothesize:
2.1 The level of effort that patients are able to apply in treatment moderates the effectiveness of time in treatment.
2.2 Family involvement in treatment is associated with better outcomes.
Data will be drawn from the database established for the TBI Practice-Based Evidence Study (TBI-PBE Study). Data on 2130 persons who received inpatient TBI rehabilitation at any of 10 sites (9 in US, 1 in Canada) were obtained for the study. Detailed longitudinal data were collected prospectively on rehabilitation therapies (with point of care data completed for every clinical encounter), course of recovery, person and injury characteristics and outcomes during and after rehabilitation. Advanced analytic methods (e.g. propensity scores, generalized linear mixed models) will be used to compare the effects of different rehabilitation interventions on outcomes at discharge and during the 9 months following rehabilitation.
- Conditions
- Brain Injuries
- Being tested
- Inpatient rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient rehabilitationBehavioural
Inpatient rehabilitation includes activities and interventions provided by occupational, physical, therapeutic recreation and speech therapists, and psychologists.
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation
Participation as measured by the Participation Assessment with Recombined Tools-Objective
Measured: 9 months post-discharge from inpatient rehabilitation
Participation
Participation as measured by the Participation Assessment with Recombined Tools-Objective
Measured: 3 months post-discharge from inpatient rehabilitation
Secondary outcomes (11)
Functional independence-Cognitive
FIM-TM Cognitive scales will be used to measure functional independence in the cognitive realm.
Measured: Upon completion of inpatient rehabilitation (discharge score), an average of 1 month
Functional independence-Cognitive
FIM-TM Cognitive scales will be used to measure functional independence in the cognitive realm.
Measured: 3 months after discharge from inpatient rehabilitation
Functional independence-Cognitive
FIM-TM Cognitive scales will be used to measure functional independence in the cognitive realm.
Measured: 9 months after discharge from inpatient rehabilitation
Functional independence-Motor
FIM-TM Motor scales will be used to measure functional independence in the cognitive realm.
Measured: Upon completion of inpatient rehabilitation (discharge score), an average of 1 month
Functional independence-Motor
FIM-TM Motor scales will be used to measure functional independence in the cognitive realm.
Measured: 3 months post-discharge from inpatient rehabilitation
Functional independence-Motor
FIM-TM Motor scales will be used to measure functional independence in the cognitive realm.
Measured: 9 months post-discharge from inpatient rehabilitation
Depressive symptoms
The Patient Health Questionnaire-9 will be used to measure depressive symptoms.
Measured: 3 months post-discharge from inpatient rehabilitation
Depressive symptoms
The Patient Health Questionnaire-9 will be used to measure depressive symptoms.
Measured: 9 months post-discharge from inpatient rehabilitation
Life satisfaction
The Satisfaction with Life Scale will be used to measure life satisfaction
Measured: 3 months post-discharge from inpatient rehabilitation
Life satisfaction
The Satisfaction with Life Scale will be used to measure life satisfaction
Measured: 9 months post-discharge from inpatient rehabilitation
Participation
Participation will be measured using the Participation Assessment with Recombined Tools-Objective
Measured: 3 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startOct 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Bogner, PhD, ABPP
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Utah
- Responsible party
- Sponsor-investigator, Jennifer Bogner, PhD, ABPP, Ohio State University
- Investigators
- Jennifer A Bogner, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646176
- Sponsor's protocol ID
- OhioU
- Acronym
- TBI-CER
- Status last verified
- Oct 2021
- First submitted
- 30 Dec 2015
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A complete de-identified dataset will be made available to the public within 9 months of completion of the analysis.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Rehabilitation Interventions for Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02646176
- Acronym / sponsor ID
- TBI-CER / OhioU
- Conditions
- Brain Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,130 participants (actual)
- Lead sponsor
- Jennifer Bogner, PhD, ABPPUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Utah
- Study start
- Oct 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Jan 2016 (estimated)
- 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 increasingly recognized as a significant public health issue, but the most effective rehabilitation methods have yet to be identified. The Institute of Medicine and the Agency for Healthcare Quality and Research sponsored systematic reviews of evidence for comparative effectiveness of rehabilitation interventions for TBI. Both reviews concluded that substantially more research is needed to identify interventions best suited for different individuals. The practice-based evidence (PBE) approach employed to create the data used in the proposed study was a research method recommended to provide greater clarity, along with use of patient-centered outcomes obtained over a longer period of time than used in previous studies.
The following specific aims will be addressed in the proposed study:
- Determine the comparative effectiveness of different therapeutic approaches used in inpatient TBI rehabilitation after statistically adjusting for patient need and ability to benefit from various approaches. Investigators hypothesize: 1.1. Patients who receive a greater proportion of therapy time in Advanced Training (versus Standard of Care) will achieve better outcomes than similar patients who receive a lesser proportion of treatment time in Advanced Training. 1.2. Patients with the greatest initial levels of disability will experience larger effects from Advanced Training therapeutic approaches in comparison to the effects experienced by patients with less disability at admission. 1.3. Patients who receive a greater proportion of therapy in contextualized treatment (versus decontextualized) will achieve better outcomes than similar patients who receive a lesser proportion of time in contextualized treatment.
- Determine the comparative effectiveness of difference in the delivery of inpatient rehabilitation therapies, after statistically adjusting for patient need and ability to benefit.
Investigators hypothesize:
2.1 The level of effort that patients are able to apply in treatment moderates the effectiveness of time in treatment.
2.2 Family involvement in treatment is associated with better outcomes.
Data will be drawn from the database established for the TBI Practice-Based Evidence Study (TBI-PBE Study). Data on 2130 persons who received inpatient TBI rehabilitation at any of 10 sites (9 in US, 1 in Canada) were obtained for the study. Detailed longitudinal data were collected prospectively on rehabilitation therapies (with point of care data completed for every clinical encounter), course of recovery, person and injury characteristics and outcomes during and after rehabilitation. Advanced analytic methods (e.g. propensity scores, generalized linear mixed models) will be used to compare the effects of different rehabilitation interventions on outcomes at discharge and during the 9 months following rehabilitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study sample was drawn from the population of persons who received inpatient rehabilitation for TBI in North America.
Key inclusion criteria (4 listed)
- Sustained a TBI, defined as damage to brain tissue caused by external force and evidenced by loss of consciousness, post-traumatic amnesia, skull fracture, or objective neurological findings
- Diagnosed with an International Classification of Diseases (ICD-9-CM) code consistent with the CDC Guidelines for Surveillance of Central Nervous System Injury
- Receiving inpatient care on a designated brain injury rehabilitation unit of one of the participating rehabilitation facilities
- Incurred a TBI severe enough to warrant inpatient rehabilitation regardless of other injuries, with TBI being the predominant reason for rehabilitation admission
Key exclusion criteria (1 listed)
- 1. None
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 |
|---|---|---|
| Inpatient rehabilitationInpatient rehabilitation includes activities and interventions provided by occupational, physical, therapeutic recreation and speech therapists, and psychologists. | Behavioural | – |
Primary outcome
Participation
Time frame: 9 months post-discharge from inpatient rehabilitation
Participation as measured by the Participation Assessment with Recombined Tools-Objective
Participation
Time frame: 3 months post-discharge from inpatient rehabilitation
Participation as measured by the Participation Assessment with Recombined Tools-Objective
11 secondary outcomes
Functional independence-Cognitive
Time frame: Upon completion of inpatient rehabilitation (discharge score), an average of 1 month
Functional independence-Cognitive
Time frame: 3 months after discharge from inpatient rehabilitation
Functional independence-Cognitive
Time frame: 9 months after discharge from inpatient rehabilitation
Functional independence-Motor
Time frame: Upon completion of inpatient rehabilitation (discharge score), an average of 1 month
Functional independence-Motor
Time frame: 3 months post-discharge from inpatient rehabilitation
Functional independence-Motor
Time frame: 9 months post-discharge from inpatient rehabilitation
Depressive symptoms
Time frame: 3 months post-discharge from inpatient rehabilitation
Depressive symptoms
Time frame: 9 months post-discharge from inpatient rehabilitation
Life satisfaction
Time frame: 3 months post-discharge from inpatient rehabilitation
Life satisfaction
Time frame: 9 months post-discharge from inpatient rehabilitation
Participation
Time frame: 3 months post-discharge
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 Oct 2021.
- Individual participant dataSharing planned: Yes. A complete de-identified dataset will be made available to the public within 9 months of completion of the analysis.
Related trials for Brain Injuries
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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.
Jennifer A Bogner, PhD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by Jennifer Bogner, PhD, ABPP.
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 1 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 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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: 9 months post-discharge from inpatient rehabilitation). 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?
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 Oct 2021.