None listed
Conditions
Brief summary
The study is a large, multi-site national clinical trial led by Deakin University in collaboration with major hospitals and research institutions across Australia. The study focuses on individuals who have experienced an assault-related TBI and aims to improve assessment, recovery support, and long-term care outcomes. Participants undergo a series of assessments, including cognitive testing, questionnaires, neuroimaging, and ecological momentary assessments. A key component of the study is the development and delivery of a personalised Survivorship Care Plan (SCP), which summarises results from participants’ assessments, provides tailored recommendations for follow-up care, and is designed to enhance communication between patients and their treating health practitioners. Findings from this study will inform the design of future Phase II and III trials and contribute to improved models of care for TBI patients.
Interventions
Following recruitment, traumatic brain injury (TBI) participants will undergo testing, which will involve neuropsychological assessment, MRI scanning and ecological momentary assessment (EMA). On day one, participants will be administered a series of questionnaires and neuropsychological assessments, and they will also undergo MRI scanning. The questionnaires will gather information regarding participants’ quality of life, their quality of sleep, their level of fatigue, PTSD symptoms, ability to perform daily life duties etc. Neuropsychological assessments will evaluate participants’ performance in a range of tests (the National Institute of Health [NIH] Toolbox Cognition Battery) including attention, speed, memory, language ability, etc. The above session will be two and a half hours long. Starting after the day-one session, EMA data will be acquired via our Streamlines EMA app for 2 weeks (daily, 10min/session) and will include a suite of in-house developed cognitive tasks (measuring processing speed, spatial working memory, inhibitory control, and cognitive flexibility), and validated questionnaires based on the Patient-Reported Outcomes Measurement Information System (PROMIS) (measuring emotional wellbeing, including depression, fatigue, pain, stress, etc.) (see full description below). EMA will be administered via participants’ mobile phones. Streamlines records app analytics and will notify the research team of each participant’s progress to ensure participants are adhering to the EMA sessions. Upon completing the EMA period, participants will be provided with their own Survivorship Care Plan ('SCP') via Streamlines, which they will then proceed to incorporate into their care over the next 2 months. The SCP is a user-friendly, interactive web-based report (i.e., HTML) accessible via the Streamlines platform that provides a personalised profile of participants’ mental health, cognitive performance and relevant brain measures. Based on these profiles, Streamlines identifies areas of improvement and formulates a care plan to assist participants in those areas. The care plan includes personalised rehabilitation and treatment recommendations, including suggestions for evidence-based therapies and referral pathways (e.g. GP mental health care plans or chronic disease management plans). The personalised profiles are generated by comparing each participant’s EMA and MRI results to a healthy control (HC) reference group using normative modelling. This approach identifies domains where an individual’s behavioural performance or MRI metrics substantially deviate from normative values (e.g., greater than 2 SD or bottom 5th percentile). These deviations then guide the selection of relevant interventions that form part of the care plan. The system then draws from an internal evidence-based library of interventions that link these specific cognitive, affective, or neural deficits to empirically supported rehabilitation strategies. For example, depending on the participant’s profile, the SCP may recommend targeted cognitive rehabilitation exercises (e.g., for attention, working memory, or executive function deficits); mindfulness-based or cognitive-behavioural therapy modules for stress or mood management; referrals for GP mental health care plans, neuropsychological follow-up, or occupational therapy; and tailored lifestyle guidance (e.g., sleep hygiene, exercise, or diet modification). SCP recommendations are reviewed by the research team before dissemination to participants. The platform also contains a library of self-paced training modules providing strategies to support recovery and wellbeing that participants can complete at their own pace (e.g., video-based content, practical exercises, and downloadable resources). The modules include a range of interventions including mindfulness, acceptance and commitment therapy, cognitive behavioural therapy, hypnotherapy, yoga, physiotherapy, and relaxation training, among others. It also includes a health promotion and psychosocial support section providing curated advice and resources on lifestyle modifications to reduce risk and improve recovery outcomes, including information on diet, exercise, sleep, healthy weight, limiting alcohol, avoiding smoking and drugs, and connecting with relevant advocacy and support groups. These modules and resources have been developed and/or adapted specifically for this study. The total number of modules will vary across participants and will depend on their specific needs. Participants will have access to only to modules recommended for them and be able to choose which modules they would like to engage with. We also encourage participants to practice modules, meaning participants could spend as little as 5-minutes to several hours per week on each intervention depending on their personal preferences. App analytics will track adherence to the modules and will notify the research team of the participant’s progress to ensure participants are adhering to their allocated modules. Participants are encouraged to nominate a health professional (e.g., their GP), who will also receive a copy of the SCP to support integration of the recommendations into ongoing care. Ongoing follow-up with the nominated health professional is optional, and adherence to the use of the SCP in future patient care will not be assessed within the scope of this Phase I study. Participant can also opt to follow the recommendations of the SCP on their own, without a health professional. Participants will retain ongoing access to the Streamlines app and SCP after completion of the study. They may continue to use the app, training modules, and SCP resources at their discretion; however, continued usage or adherence to these tools will not be tracked or monitored for research purposes.
Sponsors
Study design
Eligibility
Inclusion criteria
The inclusion criteria for all participants are as follows: 1. Are aged between 18-65 years. 2. For the TBI Group Only: Known or suspected traumatic brain injury (of any severity) at least 6 months ago and no longer than 5 years ago 3. Have access to a smartphone (Android or iOS) with internet. 4. Able to use electronic devices independently without assistance 5. Have capacity to provide informed consent (i.e., you are able to describe back to the researcher the procedure of the experiment in your own words and demonstrate a clear understanding of the nature and purpose of the study). 6. Have English-language fluency/proficiency. Healthy participants with no experience with an assault-related TBI will also be recruited as part of the healthy comparison group. The above criteria also apply to the healthy comparison group.
Exclusion criteria
• Being currently in any active or high-risk domestic violence/intimate partner violence situation • MRI exclusions, including metal implants, braces, magnetic stimulators, pacemakers, breast tissue expanders, history working with metals, claustrophobia, pregnancy • Bed-bound or in a nursing home • Have a history of a neurological disorder or disease besides TBI (e.g., brain cancer, neurodegenerative disease, stroke, etc.). • Are unable to provide informed consent. • Have a history of a severe psychiatric disorder (e.g., uncontrolled schizophrenia, actively suicidal/self-harm). • Have ongoing illicit substance use (e.g., intravenous drug use, methamphetamines). • Have auditory, motor, or visual problems that affect your ability to complete tests on a computer • Have an intellectual disability