Administrative information
Title {1} | Traumatic brain injury: needs and treatment options in the chronic phase. Study protocol for a randomized controlled community-based intervention. |
Trial registration {2a and 2b}. | ClinicalTrials.gov, NCT03545594. Registered on June 4th, 2018. https://clinicaltrials.gov/ct2/show/NCT03545594 |
Protocol version {3} | 07/02/2020, version 3.0. |
Funding {4} | The project is funded by the Research Council of Norway, project number 260673/H10. |
Author details {5a} | 1Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Norway. 2Department of Psychology, Faculty of Social Sciences, University of Oslo, Norway. 3Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway. 4Department of Research, Sunnaas Rehabilitation Hospital, Nesoddtangen, Norway. 5Center for Habilitation and Rehabilitation Models and Services (CHARM), Institute of Health and Society, University of Oslo, Norway. 6 Faculty of Health Sciences, Oslo Metropolitan University. 7Department of Health Sciences in Gjøvik, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology. 8Philadelphia Research and Education Foundation. 9Nursing Service, Department of Veterans Affairs Medical Center, Philadelphia, PA, USA |
Name and contact information for the trial sponsor {5b} | Not applicable. |
Role of sponsor {5c} | Not applicable. |
Background
Rationale {6a}
Objectives {7}
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H1: Person-centered intervention targeting the participant’s problems in functioning in their living environment will result in improved quality of life and participation compared with treatment as usual (TAU).
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H2: Person-centered intervention will result in a lower burden of self-reported TBI-related problems compared with TAU.
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H3: Person-centered intervention will result in improved physical and mental health compared with TAU.
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H4: Person-centered intervention will result in fewer unmet health-care needs compared with TAU.
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H5: Person-centered intervention will be a cost-effective alternative compared with TAU.
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H6: Patients, family members, and rehabilitation professionals involved will be satisfied with the intervention program.
Trial design {8}
Methods/design
Study setting {9}
Eligibility criteria {10}
Patient characteristics
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Outcome measure | Measures |
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Primary outcome measures | |
Participation | |
Quality of life | |
Secondary outcome measures | |
Individually identified target functional domains and their severity | Target outcomes and their severity, as rated on a Likert scale from 0 to 4 (0 = not difficult at all, 4 = extremely difficult), based on Winter et al. [29] |
Goal achievement* | Goal Attainment Scaling (GAS) [44] |
Symptom burden | Rivermead Post-Concussion Questionnaire (RPQ) [60] |
Needs for rehabilitation and social support | |
Global outcome | |
Emotional functioning (depressive and anxiety symptoms) | Patients Health Questionnaire (PHQ-9) [65] Generalized Anxiety Disorder (GAD-7) scale [66] |
Physical and mental health and quality-adjusted life years (QALYs) | EQ-5D [67] |
Competency in daily activities | |
Acceptability of intervention assessed by patient, family member and health professional* | Acceptability Scale (Scale used by Winter et al., adapted and translated into Norwegian) [29] |
Family member outcomes | |
Participant’s competency in daily activities, participant’s self-awareness | |
Caregiver burden | Caregiver Burden Scale [70] |
Family member depressive symptoms | PHQ-9 [65] |
Family member general health | EQ-5D VAS-scale (0 = worst health possible, 100 = best health possible) [67] |