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- Title
Effect of an Individually Tailored and Home-Based Intervention in the Chronic Phase of Traumatic Brain Injury: A Randomized Clinical Trial.
- Authors
Borgen, Ida M. H.; Løvstad, Marianne; Hauger, Solveig L.; Forslund, Marit V.; Kleffelgård, Ingerid; Andelic, Nada; Sveen, Unni; Søberg, Helene L.; Sigurdardottir, Solrun; Winter, Laraine; Lindstad, Marte Ørud; Brunborg, Cathrine; Røe, Cecilie
- Abstract
Key Points: Question: Does a home-based intervention that is individually tailored and goal oriented improve health-related quality of life (HRQOL) and participation and ameliorate symptoms in the chronic phase of traumatic brain injury (TBI)? Findings: In this randomized clinical trial including 120 adult participants in the chronic phase of TBI, no significant results were seen in disease-specific HRQOL or social participation. However, generic HRQOL and TBI- and anxiety-related symptom levels improved significantly in the intervention group compared with the control group. Meaning: These findings suggest that an individually tailored and goal-oriented rehabilitation program might be effective in improving generic HRQOL and symptom burden in the chronic phase of TBI. Importance: Traumatic brain injury (TBI) can cause long-lasting and heterogeneous difficulties that require an individually tailored approach to rehabilitation. However, high-quality studies of treatment options in the chronic phase of TBI are lacking. Objective: To evaluate the effect of a home-based, individualized, and goal-oriented rehabilitation intervention in the chronic phase of TBI. Design, Setting, and Participants: This study was an intention-to-treat parallel-group assessor-blinded randomized clinical trial with 1:1 randomization to an intervention or control group. Participants included adults in southeastern Norway who had sustained a TBI more than 2 years earlier, lived at home, and had ongoing TBI-related difficulties. A population-based sample of 555 individuals were invited, and 120 were included. Participants were assessed at baseline, 4 months, and 12 months after inclusion. Specialized rehabilitation therapists provided the intervention in patients' homes or via video conference and telephone. Data collection was conducted between June 5, 2018, and December 14, 2021. Interventions: The intervention group received an 8-session individually tailored and goal-oriented rehabilitation program over 4 months. The control group received usual care in their municipality. Main Outcomes and Measures: Preestablished primary outcomes were disease-specific health-related quality of life (HRQOL; measured by the Quality of Life After Brain Injury [QOLIBRI] overall scale) and social participation (measured by the Participation Assessment With Recombined Tools–Objective [PART-O] social subscale). Preestablished secondary outcomes included generic HRQOL (measured by the EuroQol 5-dimension 5-level [EQ-5D-5L] questionnaire), difficulty with TBI-related problem management (target outcomes; mean severity calculated across 3 main self-identified problem areas that were individually measured using a 4-point Likert scale), TBI symptoms (measured by the Rivermead Post Concussion Symptoms Questionnaire [RPQ]), psychological distress (depression and anxiety; measured by the Patient Health Questionnaire 9-item scale and the Generalized Anxiety Disorder 7-item scale [GAD-7], respectively), and functional competency (measured by the Patient Competency Rating Scale). Results: Among 120 participants in the chronic phase of TBI, the median (IQR) age was 47.5 (31.0-55.8) years, and the median (IQR) time since injury was 4 (3-6) years; 85 (70.8%) were male. A total of 60 participants were randomized to the intervention group, and 60 were randomized to the control group. Between baseline and 12 months, no significant between-group effects were found for the primary outcomes of disease-specific HRQOL (QOLIBRI overall scale score: 2.82; 97.5% CI, −3.23 to 8.88; P =.30) or social participation (PART-O social subscale score: 0.12; 97.5% CI, −0.14 to 0.38; P =.29). At 12 months, the intervention group (n = 57) had significantly higher generic HRQOL (EQ-5D-5L score: 0.05; 95% CI, 0.002-0.10; P =.04) and fewer symptoms of TBI (RPQ total score: −3.54; 95% CI, −6.94 to −0.14; P =.04) and anxiety (GAD-7 score: −1.39; 95% CI, −2.60 to −0.19; P =.02) compared with the control group (n = 55). At 4 months only, the intervention group (n = 59) had significantly less difficulty managing TBI-related problems (target outcomes mean severity score: −0.46, 95% CI, −0.76 to −0.15; P =.003) compared with the control group (n = 59). No adverse events were reported. Conclusions and Relevance: In this study, no significant results were observed for the primary outcomes of disease-specific HRQOL or social participation. However, the intervention group reported improvements in secondary outcomes (generic HRQOL and symptoms of TBI and anxiety) that were maintained at 12-month follow-up. These findings suggest that rehabilitation interventions could help patients even in the chronic phase of TBI. Trial Registration: ClinicalTrials.gov Identifier: NCT03545594 This randomized clinical trial assesses the effect of a home-based, individualized, and goal-oriented rehabilitation intervention among adult patients with chronic traumatic brain injury.
- Subjects
NORWAY; CONFIDENCE intervals; HOME rehabilitation; INDIVIDUALIZED medicine; TREATMENT effectiveness; RANDOMIZED controlled trials; DESCRIPTIVE statistics; QUESTIONNAIRES; RESEARCH funding; STATISTICAL sampling; DATA analysis software; REHABILITATION for brain injury patients
- Publication
JAMA Network Open, 2023, Vol 6, Issue 5, pe2310821
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2023.10821