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A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI).

ABSTRACT: Obesity rates after traumatic brain injury (TBI) are high and are associated with greater risk of morbidity (diabetes, hypertension) and mortality when compared to the general population. Evidence-based interventions for this population are needed and our work modifying and examining the efficacy of the Diabetes Prevention Program Group Lifestyle Balance (GLB-TBI) are promising. Our recent randomized controlled trial included 57 adults with TBI who completed the GLB-TBI in-person and lost 17.8 ± 16.4lbs (7.9% body weight) compared to the attention control (0%). To broaden the accessibility of the intervention we will complete an RCT to assess the efficacy of telehealth delivery (tGLB-TBI) by enrolling 88 participants over a 3 year period. Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health. The long-term goal is to reduce health inequities and broaden program dissemination to people with TBI that lack access due to environmental barriers, including living rurally or lacking transportation.

SUBMITTER: Driver S

PROVIDER: S-EPMC10382627 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI).

Driver Simon S McShan Evan Elizabeth EE Bennett Monica M Calhoun Stephanie S Callender Librada L Swank Chad C Dubiel Rosemary R

Contemporary clinical trials communications 20230717

Obesity rates after traumatic brain injury (TBI) are high and are associated with greater risk of morbidity (diabetes, hypertension) and mortality when compared to the general population. Evidence-based interventions for this population are needed and our work modifying and examining the efficacy of the Diabetes Prevention Program Group Lifestyle Balance (GLB-TBI) are promising. Our recent randomized controlled trial included 57 adults with TBI who completed the GLB-TBI in-person and lost 17.8 ± ...[more]

PMID: 37520329

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Project description:BackgroundParkinson's can impact people's speech, cognition, pragmatics, and language, significantly affecting their conversations with others. The speech and language therapy approach called communication partner training (CPT) is effective for a range of communication difficulties. However, speech and language therapy interventions for people with Parkinson's predominantly focus on impairments, with little provision of CPT for this population. Better Conversations is a CPT approach that involves working with a dyad (the person with the communication difficulty and a conversation partner [CP]) to build conversation skills. It is effective at reducing barriers to conversation, and for some, it significantly increases targeted facilitatory strategies. Some approaches to CPT have been adapted to be delivered via telehealth. This can maximize ecological validity and convenience. Furthermore, telehealth is widely accepted as a delivery method for other interventions for Parkinson's. This study presents the protocol for a pilot feasibility study of a Better Conversations CPT delivered via telehealth to people living with Parkinson's and their CPs, called Better Conversations with Parkinson's (BCP).ObjectiveThe primary aim is to evaluate the feasibility of the BCP program delivered via telehealth with a treatment group from a collaborating National Health Service (NHS) site to establish for a main trial whether BCP can be delivered as intended in an NHS setting. The aim is to establish: (1) the acceptability of the program for people living with Parkinson's, family members, and speech and language therapists (SLTs); (2) the feasibility of delivering the BCP program; (3) the recruitment and retention rates; (4) a sample size calculation; and (5) the most appropriate primary outcome measure.MethodsEthical approval for this study was obtained from London-Central Research Ethics Committee (reference: 22/LO/0332). This case-series feasibility pilot study will recruit 10-12 dyads to ensure 10 complete data sets. Participants will be recruited by a collaborating NHS site located in England. Participants will be involved for 16 weeks (weeks 1-2 preintervention measures, weeks 3-8 intervention, weeks 10-12 postintervention measures, week 16 follow-up interview). Quantitative and qualitative methods will be used to analyze the study data. Speech, communication, and quality of life assessment data will be analyzed statistically to determine a suitably sensitive outcome measure. Descriptive statistics will be used to report on recruitment, attendance, and attrition. Finally, acceptability and feasibility will be evaluated using participant feedback, interviews, and the reflective diary and feedback of the SLT administering the therapy (by the research assistant who is the first author). This data will be analyzed using descriptive statistics and reflexive thematic analysis.ResultsThis study was approved for funding from Parkinson's UK. Study recruitment commenced in July 2022. The results of the data analysis are expected to be available by September 2024.ConclusionsInsights from this study will provide valuable information about the acceptability and feasibility of a remotely delivered Better Conversations CPT approach for people living with Parkinson's and their CPs. An outcome of this study will be a manualized BCP program coproduced by people living with Parkinson's, their families, and a group of expert SLTs. The study results will guide the next stages of intervention development.International registered report identifier (irrid)PRR1-10.2196/41416.

Project description:BackgroundModerate-severe traumatic brain injury (msTBI) stands as a prominent etiology of adult disability, with increased risk for cognitive impairment and dementia. Although some recovery often occurs within the first year post-injury, predicting long-term cognitive outcomes remains challenging, partly due to the significant pathophysiological heterogeneity of TBI, including acute cerebrovascular injury. The primary aim of our recently funded study, cerebral autoregulation, brain perfusion, and neurocognitive outcomes after traumatic brain injury (CAPCOG-TBI), is to determine if acute cerebrovascular dysfunction after msTBI measured using multimodal non-invasive neuromonitoring is associated with cognitive outcome at 1-year post-injury.MethodsThis longitudinal observational study will be conducted at two Level 1 trauma centers in Texas, USA, and will include adult patients with msTBI, and/or mild TBI with neuroimaging abnormalities. Multimodal cerebral vascular assessment using transcranial Doppler and cerebral near-infrared spectroscopy (NIRS) will be conducted within 7-days of onset of TBI. Longitudinal outcomes, including cognitive/functional assessments (Glasgow Outcome Scale and Patient-Reported Outcomes Measurement Information System), cerebral vascular assessment, and imaging will be performed at follow-ups 3-, 6-, and 12-months post-injury. We aim to recruit 100 subjects with msTBI along with 30 orthopedic trauma controls (OTC). This study is funded by National Institute of Neurological Disease and Stroke (NINDS) and is registered on Clinicaltrial.org (NCT06480838).Expected resultsWe anticipate that msTBI patients will exhibit impaired cerebrovascular function in the acute phase compared to the OTC group. The severity of cerebrovascular dysfunction during this stage is expected to inversely correlate with cognitive and functional outcomes at 1-year post-injury. Additionally, recovery from cerebrovascular dysfunction is expected to be linked to cognitive recovery.ConclusionThe results of this study could help to understand the contribution of cerebrovascular dysfunction to cognitive outcomes after TBI and pave the way for innovative vascular-focused interventions aimed at enhancing cognitive recovery and mitigating neurodegeneration following msTB. In addition, its focus toward personalized medicine to aid in the management and prognosis of TBI patients.

Project description:BackgroundTraumatic injuries, defined as physical injuries with sudden onset, are a major cause of distress and disability, with far-reaching societal consequences. A significant proportion of trauma survivors report persistent symptoms and difficulties after the injury, and studies show unmet health care needs. Self-management programs delivered in the sub-acute phase after traumatic injuries are scarcely evaluated. The aim of the present study is to evaluate the effectiveness of a self-management program (SEMPO), delivered 3-4 months after moderate-to-severe traumatic injury.MethodsThis study protocol describes a pragmatic randomized controlled trial (RCT) with two classical RCT arms (intervention and control) and an explorative self-selection arm. 220 patients will be recruited from Oslo University Hospital, the largest Trauma Referral Centre in Norway. Patients aged 18-72 years residing in the south-east region of Norway, admitted to the Trauma Centre directly or within 72 h after having sustained a moderate to severe traumatic injury, defined as a New Injury Severity Score > 9, having at least 2 days hospital stay, and reporting injury-related symptoms and impairment at discharge from the acute hospital will be included. Patients will be randomly assigned to either a classical RCT randomization arm (intervention or control arm) or to a self-selection arm. In the randomization arm, participants are further randomized into intervention or control group. Participants allocated to the self-selection arm will choose to partake either in the intervention or control arm. The primary outcome is the level of self-efficacy in trauma coping assessed 6 months after completion of the intervention, with a similar time point for the control group. Secondary outcomes include symptom burden, physical functioning and disability, return to work and health care utilization, health-related quality of life, and communication competency. In addition, patients will be asked to nominate one domain-related measurement as their preferred outcome measure.DiscussionThis RCT will determine the effect of a self-management program tailored to patients with moderate to severe physical trauma, and the self-selection arm incorporates the potential influence of patient treatment preferences on intervention results. If the intervention proves effective, cost-effectiveness and cost-utility analyses will be performed and thereby provide important information for clinicians and policy makers.Trial registrationThe study is registered in Clinical Trials with the identifier: NCT06305819. Registered on March 05, 2004.

Dataset Information

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI).

Publications

A randomized controlled trial protocol for people with traumatic brain injury enrolled in a telehealth delivered diabetes prevention program (tGLB-TBI).

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