Optimizing Measures for Clinical Trials in Covert Hepatic Encephalopathy
隐性肝性脑病临床试验的优化措施
基本信息
- 批准号:10132309
- 负责人:
- 金额:$ 19.4万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-07-01 至 2023-03-31
- 项目状态:已结题
- 来源:
- 关键词:Abdominal MusclesAddressAdrenergic beta-AntagonistsAdverse eventAlbuminsAmericanAmmoniaAreaAscitesBilirubinBloodBrainCalibrationCaloriesCatabolic ProcessCessation of lifeChronicCirrhosisClinicalClinical TrialsClinical Trials DesignCodeComaComplicationComputersConfusionDataData AnalysesDevelopmentDiagnosisDietDietary InterventionDisorientationElectronic MailEnrollmentExecutive DysfunctionExerciseExposure toFall preventionFeasibility StudiesFocus GroupsGoalsGoldGrantHandHemorrhageHepatic EncephalopathyHospitalizationInpatientsInterventionInterviewInvestigationKnowledgeLethargiesMalnutritionMaster&aposs DegreeMeasuresMentorshipMethodologyMethodsModelingMuscleMuscle functionNutritionalOnline SystemsOutcomeOutpatientsPathway interactionsPatient Outcomes AssessmentsPatient SelectionPatientsPersonal SatisfactionPharmaceutical PreparationsPhysical FunctionPortal HypertensionPositioning AttributeProspective cohortProteinsPublishingRandomized Controlled TrialsResearchResearch PersonnelRetrospective cohortRiskRisk FactorsSeveritiesStructureTalentsTestingText MessagingTimeTrainingTraining ProgramsVoiceWorkabdominal CTarmauthoritybasecareerchronic liver diseaseclinical investigationclinical predictorscognitive changecognitive functioncohortcostdaily functioningdisabilityexecutive functionexercise interventionfallsgrasphealth care service utilizationhealth related quality of lifehigh riskimprovedinattentioninsightmodifiable riskmortalityneurocognitive testneuropsychiatrynovelnutritionpatient orientedpoint of carepredictive modelingpreventprospectiverandomized trialresistance exerciseresponserisk predictionrisk stratificationsarcopeniasuccesstherapeutic targettherapy designtoolvehicular accidentwasting
项目摘要
Optimizing Measures for Clinical Trials in Covert Hepatic Encephalopathy
PI: Elliot B. Tapper, MD
Among all complications of cirrhosis, none is more devastating than hepatic encephalopathy (HE). Although it
will afflict up to 40% of patients with cirrhosis, HE has few dedicated researchers. A spectrum of
neuropsychiatric disability, HE ranges in severity from covert (deficits in executive function) to overt (confusion,
even coma). Even covert HE – the earliest stage – is independently associated with repeated hospitalization,
falls, motor vehicle accidents and death. Unfortunately, strategies to prevent the development HE are limited.
Furthermore, investigations of potential therapies are complicated by limited knowledge of both the clinical
predictors of HE and impact on patient well-being and daily functions. This grant proposes to close these gaps.
The training program aims to prepare the applicant for a career vested in identifying risk factors for HE, and in
designing interventions to prevent HE and to improve patient well-being. A master's degree in clinical
investigation with targeted additional courses will provide training in clinical trial design, calibration of patient
reported measures for clinical trials, and longitudinal data analysis to develop clinical predictive models. The
mentorship team assembled is diverse and talented, including Dr. Anna Lok (a clinical trialist and content
expert), Dr. Jasmohan Bajaj (an authority on HE and clinical trials), Dr. Noelle Carlozzi (a neuropsychologist
with expertise in mixed-methodology), and Dr. Susan Murphy (a trialist with a focus on interventions for frail
patients). In research aim 1, we will determine the most important domains of health related quality of life
(HRQOL) for patients with covert HE. In Aim 2, we will analyze a cohort of 300 cirrhosis patients without HE
followed for up to 4 years to determine the modifiable risk factors for HE and to develop predictive models for
HE and falls. In Aim 3, we will launch a pilot intervention aimed at the improvement of HRQOL and prevention
of falls in patients with covert HE using a web-based platform that co-ordinates a combination of text-message,
email and interactive-voice response to deliver structured encouragement to meet nutritional and exercise
goals aimed at improving sarcopenia. By the conclusion of the K23, the applicant will be positioned for
academic success with a niche in an important complication of cirrhosis and providing necessary preliminary
data for an R01 supporting a larger, randomized trial.
隐性肝性脑病临床试验的优化措施
项目成果
期刊论文数量(0)
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科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Elliot Tapper其他文献
Elliot Tapper的其他文献
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{{ truncateString('Elliot Tapper', 18)}}的其他基金
Optimizing Measures for Clinical Trials in Covert Hepatic Encephalopathy
隐性肝性脑病临床试验的优化措施
- 批准号:
10382474 - 财政年份:2019
- 资助金额:
$ 19.4万 - 项目类别:
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