An observational study in Brain Injuries, sponsored by Jennifer Bogner, PhD, ABPP. Completed. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2021-10-28.
Sponsored by Jennifer Bogner, PhD, ABPP · Observational
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 2,130 is above the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →Jennifer Bogner, PhD, ABPP is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study sample was drawn from the population of persons who received inpatient rehabilitation for TBI in North America.
Exclusion Criteria:
Inpatient rehabilitation includes activities and interventions provided by occupational, physical, therapeutic recreation and speech therapists, and psychologists.
Participation
Participation as measured by the Participation Assessment with Recombined Tools-Objective
Time frame: 9 months post-discharge from inpatient rehabilitation
Participation
Participation as measured by the Participation Assessment with Recombined Tools-Objective
Time frame: 3 months post-discharge from inpatient rehabilitation
Functional independence-Cognitive
FIM-TM Cognitive scales will be used to measure functional independence in the cognitive realm.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9 months post-discharge from inpatient rehabilitation
Depressive symptoms
The Patient Health Questionnaire-9 will be used to measure depressive symptoms.
Time frame: 3 months post-discharge from inpatient rehabilitation
Depressive symptoms
The Patient Health Questionnaire-9 will be used to measure depressive symptoms.
Time frame: 9 months post-discharge from inpatient rehabilitation
Life satisfaction
The Satisfaction with Life Scale will be used to measure life satisfaction
Time frame: 3 months post-discharge from inpatient rehabilitation
Life satisfaction
The Satisfaction with Life Scale will be used to measure life satisfaction
Time frame: 9 months post-discharge from inpatient rehabilitation
Participation
Participation will be measured using the Participation Assessment with Recombined Tools-Objective
Time frame: 3 months post-discharge
No study locations are listed for this record.
Plan to share: Yes — A complete de-identified dataset will be made available to the public within 9 months of completion of the analysis.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Jennifer Bogner, PhD, ABPP