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Supporting caregivers of veterans with Alzheimer's disease and traumatic brain injury: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Patients with Alzheimer's disease and related dementias (ADRD) and traumatic brain injury (TBI) and their caregivers require cognitive and behavioral symptom management, interdisciplinary care, support for caregivers, and seamless care coordination between providers. Caring for someone with ADRD or TBI is associated with higher rates of psychological morbidity and burden, social isolation, financial hardship, and deterioration of physical health. Tremendous need exists for primary care-based interventions that concurrently address the care needs of dyads and aim to improve care and outcomes for both individuals with ADRD and TBI and their family caregivers. METHODS:The Aging Brain Care Acquiring New Skills While Enhancing Remaining Strengths (ABC ANSWERS) study is a randomized controlled trial that tests the effectiveness of an intervention based on two evidence-based programs that have been developed for and previously tested in populations with ADRD, TBI, stroke, and late-life depression and/or who have survived an intensive care unit stay. This study includes 200 dyads comprised of a veteran with a diagnosis of ADRD or TBI and the veteran's primary informal caregiver. Dyads are randomized to receive the ABC ANSWERS intervention or routine Veterans Health Administration (VHA) primary care with a standardized educational and resource information packet. Data collection occurs at baseline and three follow-up time points (3?months, 6?months, and 12?months). The primary outcome is caregiver quality of life (QoL). A secondary measure for the caregiver is caregiver burden. Secondary measures for both the veteran and caregiver include symptoms of depression and anxiety. DISCUSSION:The ABC ANSWERS intervention integrates common features of an evidence-based collaborative care model for brain health while concurrently attending to the implementation barriers of delivering care and skills to dyads. We hypothesize that caregivers in dyads randomized to the ABC ANSWERS program will experience higher levels of QoL and lower levels of depression, anxiety, dyadic strain, and caregiver burden at 12?months than those receiving usual VHA primary care. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03397667. Registered on 12 January 2018.

SUBMITTER: Carnahan JL

PROVIDER: S-EPMC7168967 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Supporting caregivers of veterans with Alzheimer's disease and traumatic brain injury: study protocol for a randomized controlled trial.

Carnahan Jennifer L JL Judge Katherine S KS Daggy Joanne K JK Slaven James E JE Coleman Nicki N Fortier Emily L EL Suelzer Christopher C Fowler Nicole R NR

Trials 20200419 1

<h4>Background</h4>Patients with Alzheimer's disease and related dementias (ADRD) and traumatic brain injury (TBI) and their caregivers require cognitive and behavioral symptom management, interdisciplinary care, support for caregivers, and seamless care coordination between providers. Caring for someone with ADRD or TBI is associated with higher rates of psychological morbidity and burden, social isolation, financial hardship, and deterioration of physical health. Tremendous need exists for pri ...[more]

PMID: 32306982

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Project description:ImportanceThere are limited data on which factors affect the critical and complex decision to withdraw life-supporting treatment (LST) in patients with severe traumatic brain injury (sTBI).ObjectiveTo determine demographic and clinical factors associated with the decision to withdraw LST in patients with sTBI.Design, setting, and participantsThis retrospective analysis of inpatient data from more than 825 trauma centers across the US in the American College of Surgeons Trauma Quality Improvement Program database from January 2013 to December 2015 included adult patients with sTBI and documentation of a decision regarding withdrawal of LST (WLST). Data analysis was conducted in September 2019.Main outcomes and measuresFactors associated with WLST in sTBI.ResultsA total of 37931 patients (9817 women [25.9%]) were included in the multivariable analysis; 7864 (20.7%) had WLST. Black patients (4806 [13.2%]; odds ratio [OR], 0.66; 95% CI, 0.59-0.72; P < .001) and patients of other race (4798 [13.2%]; OR, 0.83; 95% CI, 0.76-0.91; P < .001) were less likely than white patients (26 864 [73.7%]) to have WLST. Patients from hospitals in the Midwest (OR, 1.12; 95% CI, 1.04-1.20; P = .002) or Northeast (OR, 1.23; 95% CI, 1.13-1.34; P < .001) were more likely to have WLST than patients from hospitals in the South. Patients with Medicare (OR, 1.55; 95% CI, 1.43-1.69; P < .001) and self-pay patients (OR, 1.36; 95% CI, 1.25-1.47; P < .001) were more likely to have WLST than patients with private insurance. Older patients and those with lower Glasgow Coma Scale scores, higher Injury Severity Scores, or craniotomy were generally more likely to have WLST. Withdrawal of LST was more likely for patients with functionally dependent health status (OR, 1.30; 95% CI, 1.08-1.58; P = .01), hematoma (OR, 1.19; 95% CI, 1.12-1.27; P < .001), dementia (OR, 1.29; 95% CI, 1.08-1.53; P = .004), and disseminated cancer (OR, 2.82; 95% CI, 2.07-3.82; P < .001) than for patients without these conditions.Conclusions and relevanceWithdrawal of LST is common in sTBI and socioeconomic factors are associated with the decision to withdraw LST. These results highlight the many factors that contribute to decision-making in sTBI and demonstrate that in a complex and variable disease process, variation based on race, payment, and region presents as a potential challenge.

Project description:BackgroundTraumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.Methods/designThe erythropoietin in traumatic brain injury trial is a stratified prospective, multi-centre, randomised, blinded, parallel-group, placebo-controlled phase III trial. It aims to determine whether the administration of erythropoietin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at six months after injury. The trial is designed to recruit 606 patients between 15 and 65 years of age with severe (Glasgow Coma Score: 3 to 8) or moderate (Glasgow Coma Score: 9 to 12) traumatic brain injury in Australia, New Zealand, Kingdom of Saudi Arabia, France, Finland, Germany and Ireland. Trial patients will receive either subcutaneous erythropoietin or placebo within 24 hours of injury, and weekly thereafter for up to three doses during the intensive care unit admission. The primary outcome will be the combined proportion of unfavourable neurological outcomes at six months: severe disability or death. Secondary outcomes will include the rate of proximal deep venous thrombosis detected by compression Doppler ultrasound, six-month mortality, the proportion of patients with composite vascular events (deep venous thrombosis, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at six months and quality of life with health economic evaluations.DiscussionWhen completed, the trial aims to provide evidence on the efficacy and safety of erythropoietin in traumatic brain injury patients, and to provide clear guidance for clinicians in their management of this devastating condition.Trial registrationAustralian New Zealand Clinical Trials registry: ACTRN12609000827235 (registered on 22 September 2009). Clinicaltrials.gov: NCT00987454 (registered on 29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (registered on 18 January 2012).

Project description:Background: Experimental evidence has indicated the benefits of intraoperative controlled decompression for the treatment of severe traumatic brain injury (sTBI). Intraoperative rapid decompression (conventional decompression) for the treatment of sTBI may result in intra- and post-operative complications. Controlled decompression may reduce these complications. Previous clinical trials in China have not yielded conclusive results regarding controlled decompression for sTBI. Therefore, we explored whether controlled decompression treatment decreases the rates of complications and improves the outcomes of patients with sTBI. Methods: We performed this randomized, controlled trial at our hospital. Patients with sTBI aged 18-75 years old were randomly (1:1) divided into controlled decompression surgery (n = 124) or rapid decompression surgery groups (n = 124). The primary outcome measures were the Extended Glasgow Outcome Scale (GOS-E) score at 6 months and 30-days all-cause mortality. The secondary outcomes were the incidences of intraoperative brain swelling, post-traumatic cerebral infarction, and delayed hematoma. Results: Compared with the rapid decompression group, the controlled decompression group had reduced 30-days all-cause mortality (18.6 vs. 30.8%, P = 0.035) and improved the 6-months GOS-E scores, and the difference was significant. In addition, the patients in the controlled decompression group had a lower intraoperative brain swelling rate (13.3 vs. 24.3%, P = 0.036), a lower delayed hematoma rate (17.7 vs. 29.0%, P = 0.048) and a relatively lower post-traumatic cerebral infarction rate (15.0 vs. 22.4%, P = 0.127) than those in the rapid decompression group. Conclusions: Our data suggest that controlled decompression surgery significantly improves sTBI outcomes and decreases the rates of sTBI-related complications. However, this was a single-hospital study, and well-designed multicenter randomized controlled trials are needed to evaluate the effects of controlled decompression surgery for the management of patients with sTBI. Clinical Trial Registration: Chinese Clinical Trial Registry; Date: 14/Dec/2013; Number: ChiCTR-TCC-13004002.

Project description:BackgroundApproximately 1 million individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year. Many trauma survivors with mild TBI have debilitating and long-term physical, emotional, and cognitive impairments that are unrecognized at trauma centers. Early intervention studies are needed to address these impairments, especially cognitive deficits in executive functioning. Goal management training (GMT) is a structured cognitive rehabilitation program that has been found to improve executive functioning in patients with moderate to severe TBI. The current study adapted the GMT program for telephone delivery in order to improve the accessibility of rehabilitation services in a patient population with multiple barriers to care and significant yet unrecognized cognitive impairment. The primary objective of this study is to examine the efficacy of telephone-based GMT for improving executive functioning, functional status, and psychological health in trauma survivors with mild TBI.Methods/designThis study is a three-group randomized controlled trial being conducted at a Level I trauma center. Ninety trauma survivors with mild TBI and cognitive deficits in executive functioning will be randomized to receive telephone-based GMT, telephone-based education, or usual care. GMT and education programs will be delivered by a physical therapist. The first in-person session is 1 h and the remaining six telephone sessions are 30 min. A battery of well-established cognitive tests will be conducted and validated questionnaires will be collected that measure executive functioning, functional status, and depressive and posttraumatic stress disorder symptoms at 6 weeks, 4 months, and 7 months following hospital discharge.DiscussionThis study supports a telephone-delivery approach to rehabilitation services in order to broaden the availability of evidence-based cognitive strategies.Trial registrationThis trial was registered with Clinicaltrials.gov on 10 October 2012, registration number: NCT01714531.

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Supporting caregivers of veterans with Alzheimer's disease and traumatic brain injury: study protocol for a randomized controlled trial.

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Supporting caregivers of veterans with Alzheimer's disease and traumatic brain injury: study protocol for a randomized controlled trial.

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