COMPUTATIONAL AND MATHEMATICAL MODELING OF BIOMEDICAL SYSTEMS
W Timothy, Professor
University Of Arizonacity: Tucson country: United States (us)
Grant 5T32GM084905-03 from National Institute Of General Medical Sciences
Abstract: This program will prepare scientists for research careers in the computational analysis and mathematical modeling of medically significant biological systems through interdisciplinary training at the predoctoral level. Noted for its well-established system of interdisciplinary graduate programs and for its tradition of collaborations across departmental boundaries, the University of Arizona provides a highly suitable environment for such training. Seventeen training faculty and two associate faculty with appointments in multiple departments and interdisciplinary graduate programs provide strength in three broad areas molecular dynamics; cellular processes; physiology and pathophysiology. Students will be drawn primarily from the interdisciplinary Program in Applied Mathematics and the cross-disciplinary Biochemistry and Molecular & Cellular Biology Program. Qualified students from other graduate programs will also be eligible. In most cases, students will receive support starting in their second year of graduate training. Trainees will pursue the coursework requirements of their own graduate programs and will, in addition, take graduate courses in bioinformatics, biostatistics and mathematical modeling tailored to their diverse scientific backgrounds. Trainees will take part in a weekly biomathematics colloquium that has been running continuously for more than a decade and promotes dialog between trainees and faculty with primarily mathematical or computational backgrounds and those with strong biological training. Trainees will carry out doctoral research with advisors whose research, whether theoretical or experimental, emphasizes application of theoretical approaches to biomedical problems. Where appropriate, a co-advisor will be appointed to provide complementary expertise to that of the primary advisor. Trainees participating in this program will not only receive research training in relevant areas, but will also develop the ability to communicate and collaborate across traditional disciplinary boundaries and to work with researchers with complementary expertise. Researchers with such skills are critically needed in many areas of biomedical science in which sophisticated theoretical approaches are necessary in order to achieve further progress. Relevance In many areas of biomedical science, sophisticated theoretical approaches are necessary in order to achieve further progress. This program will prepare scientists for research careers in the computational analysis and mathematical modeling of medically significant biological systems through interdisciplinary training at the predoctoral level
Keywords: Computer Simulation; mathematical model; System
Project start date: 2009-07-01
Project end date: 2014-06-30
Budget start date: 1-JUL-2011
Budget end date: 30-JUN-2012
PFA/PA: PA-06-468
5T32GM084905-03 (2011): $197850
Sponsored Links Excellgen http://Excellgen.com
Grants awarded to W Timothy
IMPLEMENTING TREATMENT INITIATIVES FOR CRIMINAL JUSTICE CLIENTS
W Timothy, Senior Research Scientist
Friends Research Institute, Inc.city: Baltimore country: United States (us)
Grant 5U01DA025233-02 from National Institute On Drug Abuse
Abstract: With greater availability of evidence-based practices in the drug abuse field, specifically, for offender clients, it is crucial that we develop strategies that allow for the adoption, implementation and sustaining of aids to effective clinical practice. The task of establishing new, research driven initiatives requires accommodation by the host organization to permit support for the continuing use of those initiatives with appropriate levels of fidelity. With offender clients, the use of a continuum of care becomes particularly critical in as much as treatment initiatives begun in institutional settings need to be built upon and continued through the period of community reentry, making use of community-based treatment or other community resources. The effective implementation of treatment involving a continuum of care then requires work with two organizational systems - criminal justice and drug treatment - with both complementary and differing interests and concerns. We have set out an implementation strategy designed to allow these two systems to coordinate their efforts and support the adoption and maintenance of the three continuum of care initiatives described (1) the use of Project RESPECT to initiate HIV prevention efforts in the institution, and continue that intervention into the community as offender clients are thrust into situations capable of triggering risk-taking behaviors; (2)within the institutional setting we propose to administer the Level of Service Inventory to determine areas of risk and of offender need, and the Criminal Thinking Scales to permit assignment of offender clients to appropriate levels of care as they reenter the community; (3) a treatment intervention involving the administration of methadone through the comparison of Interim Methadone Maintenance as compared to regular methadone maintenance initiated in detention centers in order to enable a transition to the community. It is critical that we work with criminal justice and treatment organizations to enable them to adopt, implement into organizational settings, and sustain evidence-based treatment strategies that permit a continuum of care from criminal justice to community settings. The proposed initiatives may reduce adverse public health and public safety consequences of relapse as well as increase organizational functioning for both drug treatment and criminal justice agencies
Keywords: Adopted; Adoption; AIDS prevention; Area; Behavior; Caring; Client; clinical practice; Communities; community based treatment; community reentry; community setting; Continuity of Patient Care; Criminal Justice; criminal thinking; design; detention center; Drug abuse; Equipment and supply inventories; Evidence based practice; Evidence based treatment; Institution; interest; Intervention; Maintenance; Methadone; methadone maintenance; offender; Pharmaceutical Preparations; public health medicine (field); public health relevance; Relapse; Research; Resources; Risk; Risk-Taking; Safety; Services; System; treatment organization; treatment strategy; Work
Project start date: 2009-08-01
Project end date: 2012-07-31
Budget start date: 1-AUG-2010
Budget end date: 31-JUL-2012
PFA/PA: RFA-DA-08-002
5U01DA025233-02 (2010): $489132
BLOOD FLOW AND STRUCTURAL ADAPTATION IN MICROCIRCULATION
W Timothy, Professor
University Of Arizonacity: Tucson country: United States (us)
Grant 5R01HL034555-26 from National Heart, Lung, And Blood Institute
Abstract: Resistance to blood flow in peripheral vascular beds strongly influences cardiovascular function and tissue perfusion. The primary determinants of flow resistance are the geometrical structure of the vasculature and the flow properties of the blood. The vascular system is capable of dynamic structural change during growth and maturation, and in response to varying conditions occurring in health, injury and disease. Growth of new vessels, structural adaptation (remodeling) of vessels, and vessel regression lead to redistribution of blood flow. Abnormal structural adaptation and angiogenesis occur in hypertension and other diseases. Specific Aim 1 is to develop theoretical models for the dynamics of structural adaptation. The models will be used to predict the time-course of diameters and wall thicknesses in vascular networks following alterations in hemodynamic or metabolic conditions. The relationship between vascular tone and structural adaptation will be explored. Predictions will be compared with observations in mouse hind-limb and skin-fold preparations. Specific Aim 2 is to develop theoretical models for growth and regression of vascular networks. Sprouting and growth of new segments from existing segments, connection of segments to form new flow pathways, structural adaptation of flowing pathways, and loss of redundant segments will be simulated. Effects of the spatial distributions of oxygen and growth factor concentrations will be included. Resulting network structures will be compared with experimental data obtained from rat mesentery and mouse skin-fold preparations. The flow properties of blood strongly affect perfusion and flow resistance in the microcirculation. Two key factors are radial migration of red blood cells, causing a cell-depleted layer near vessel walls, and the presence of a relatively thick endothelial surface layer lining the walls. Specific Aim 3 is to develop multi-cell models for blood flow in microvessels, including effects of the endothelial surface layer. Motion of red blood cells will be simulated and the width of the cell-depleted layer will be predicted. Results will be compared with experimental observations in the rat mesentery. In all these studies, emphasis will be placed on examining the physiological implications of the results in normal and abnormal states including hypertension. This will be facilitated by well-established and active collaborations with experimental physiologists
Keywords: Affect; Agreement; angiogenesis; Behavior; Biological Process; Blood; Blood flow; Blood Flow Velocity; Blood Vessels; Caliber; Cardiovascular Physiology; Cell model; Cells; Collaborations; Convection; Data; density; Disease; Erythrocytes; Gel; Glycocalyx; Goals; Grant; Growth; Growth Factor; Health; hemodynamics; Hypertension; Implant; Injury; Lead; Limb structure; Mechanics; Mesentery; Metabolic; Microcirculation; migration; Modeling; Motion; Mus; new growth; Oxygen; Partial Pressure; Pathway interactions; Perfusion; Peripheral; physical process; Physiological; Preparation; Process; programs; Property; Radial; Rattus; Research Personnel; Resistance; response; shear stress; Simulate; Skin; Spatial Distribution; Stimulus; Stress; Structure; Surface; Theoretical model; Thick; Time; Tissues; vascular bed; Vascular System; Vasodilator Agents; vessel regression; Width
Project start date: 1985-07-01
Project end date: 2012-03-31
Budget start date: 1-APR-2011
Budget end date: 31-MAR-2012
5R01HL034555-26 (2011): $148593
FLOW REGULATION AND OXYGEN TRANSPORT IN MICROCIRCULATION
W Timothy, Professor
University Of Arizonacity: Tucson country: United States (us)
Grant 5R01HL070657-10 from National Heart, Lung, And Blood Institute
Abstract: Regulation of blood flow is a central topic in cardiovascular biology. Many disorders involve dysfunctional flow regulation, and vasoactive drugs are frequently used in treating these disorders. Delivery of an adequate oxygen supply is the most critical function of the circulatory system. The overall objective of this project is to develop quantitative theoretical models for blood flow regulation and oxygen transport in microvascular networks. In prior studies supported by this grant, we developed a model for steady-state flow regulation in a network with a homogeneous structure. That model, which will form the basis for the proposed studies, has provided insights into the roles of myogenic, metabolic, shear-dependent and conducted responses and oxygen-dependent release of ATP by red blood cells in the regulation of flow. In the proposed work, we will examine the effects of heterogeneity, time-dependent behavior and capillary recruitment on flow regulation. Specific Aim 1 is to develop theoretical models for flow regulation in microvascular networks with inhomogeneous structures and spatially varying metabolic demand. The models will be used to investigate the mechanisms by which perfusion is locally matched to metabolic demand in normal tissue and how this fails in abnormal states. Specific Aim 2 is to develop theoretical models for time- dependent flow regulation in response to changes in metabolic demand and arterial pressure, and to apply this model to analyze spontaneous oscillations in arteriolar diameter and blood flow (arteriolar vasomotion) that occur in some conditions. Specific Aim 3 is to develop theoretical models including effects of capillary recruitment, and to test their ability to describe the more than 25-fold observed dynamic range of skeletal muscle perfusion. In all these studies, emphasis will be placed on comparing model predictions with available experimental data and using these data to further develop, test and refine the models. This process will be facilitated by well established collaborations with two consultants, Dr. Axel Pries and Dr. Tuhin Roy, who have extensive experience in relevant experimental basic science and clinical areas respectively. How blood flow is regulated, i.e., how perfusion is matched to tissue demands and maintained despite changes in arterial pressure, is a central question in cardiovascular biology. The overall objective of the proposed studies is to develop quantitative theoretical models for blood flow regulation and oxygen transport in microvascular networks. The models will clarify the roles of mechanisms that coordinate blood flow with local tissue requirements, will provide a rational structure for interpreting experimental data, and may lead to improved therapeutic approaches for controlling tissue perfusion
Keywords: Accounting; active control; Area; Arteries; arteriole; base; Basic Science; Behavior; Biology; Blood; Blood capillaries; Blood flow; Blood Vessels; Caliber; capillary; Cardiovascular Physiology; Cardiovascular system; Cells; Clinical; Collaborations; Coupled; Data; Diffuse; Disease; Erythrocytes; experience; Grant; Heterogeneity; Hypoxia; improved; Individual; insight; Intervention; Ischemia; Lead; Learning; Mechanics; Metabolic; Microcirculation; Modeling; Muscle Tonus; Normal tissue morphology; Oxygen; oxygen transport; Perfusion; Pharmaceutical Preparations; pressure; Process; public health relevance; Regulation; response; Role; Skeletal muscle structure; Smooth muscle (tissue); spatial temporal variation; Structure; Testing; Theoretical model; Therapeutic; Time; Tissues; Transport Process; Variant; Vascular System; Vasodilation; vasomotion; Work
Project start date: 2002-05-03
Project end date: 2015-04-30
Budget start date: 1-MAY-2011
Budget end date: 30-APR-2012
PFA/PA: PA-07-070
5R01HL070657-10 (2011): $186394
W Timothy, Senior Research Scientist
Friends Research Institute, Inc.city: Baltimore country: United States (us)
Grant 3R01DA021579-04S1 from National Institute On Drug Abuse
Abstract: Prisoners with pre-incarceration heroin addiction histories rarely receive drug abuse treatment while incarcerated, or upon release. Re-addiction among such individuals typically occurs within one month of release, placing these individuals at disproportionately high risk for HIV and hepatitis B and C infections, overdose death, increased criminal activity, and re-incarceration. Research is clearly needed to evaluate the effectiveness of innovative drug treatment interventions spanning incarceration and the community. Based on substantial evidence of the effectiveness of opioid agonist treatment in the community, and the authors´ considerable investigative experience with prison-initiated opioid agonist maintenance treatment of male inmates, a five-year study is proposed to examine the effectiveness of the administration of buprenorphine to previously-addicted inmates initiated in the institution and continued on release to the community. Moreover, the proposed study would be the first to examine the effectiveness of opioid agonist therapy for female (n=160) as well as male (n=160) pre-release inmates with pre-addiction heroin addiction histories. Finally, the proposed research will examine the extent to which the setting of post-release buprenorphine is provided [in an opioid agonist treatment program (OTP) vs. a community health center (CHC)]. Participants will be randomly assigned, within gender, to one of four treatment conditions 1) buprenorphine and counseling in prison, with referral for continued treatment at an OTP upon release; 2) buprenorphine and counseling in prison, with referral for continued treatment at a CHC upon release; 3) counseling only in prison, with referral for buprenorphine and counseling at a OTP upon release; and 4) counseling only in prison, with referral for buprenorphine and counseling at a CHC upon release. Participants will be assessed at study entry and at 1, 3, 6, and 12 months following their release from prison. Outcome measures include treatment entry and retention in the community, heroin use, cocaine use, HIV infection, HIV-risk behaviors, criminal activity, and employment. Relevance While there have been substantial advances in the effectiveness of drug abuse treatment, only limited improvements have occurred in the provision of treatment services in non-research settings. Therefore, both researchers and practitioners have emphasized the need for rigorous research to examine the delivery of treatment services to heroin-dependent individuals in "real-world" settings, including prisons and community health centers. The presently proposed clinical trial aims to bridge this gap by examining the extent to which opioid maintenance treatment initiated in prison for inmates with a history of opioid addiction and the type of post-release treatment setting to which they are referred has an impact on public health and public safety outcomes in pre-release prison inmates
Keywords: addiction; Address; Adoption; Aftercare; Agonist; base; Buprenorphine; Centers for Disease Control and Prevention (U.S.); Clinical Trials; Cocaine Abuse; cocaine use; Communities; community based treatment; Community Health Centers; Comprehensive Health Care; Controlled Clinical Trials; Correctional Institutions; Counseling; design; Development; Dose; Drug abuse; early onset; effective therapy; Effectiveness; Employment; Enrollment; experience; Female; France; Gender; Health; Health Services; Health Services Accessibility; Hepatitis B; Hepatitis C; Heroin; Heroin Dependence; high risk; HIV; HIV Infections; HIV Seropositivity; Imprisonment; Individual; Infection; innovation; Institution; Intervention; Maintenance; male; Medical; men; Mental Health; Mental Health Services; Methadone; methadone maintenance; Naloxone; New York City; offender; Opiate Addiction; Opioid; Outcome; Outcome Measure; overdose death; Participant; Pharmaceutical Preparations; Prisoner; Prisons; Procedures; programs; Property; public health medicine (field); Randomized; Recording of previous events; Regulation; Rehabilitation therapy; Relapse; Relative (related person); Research; Research Design; Research Personnel; Risk Behaviors; Safety; Sampling; Security; Services; Sex Characteristics; Sexual abuse; social stigma; Social Welfare; Societies; Spouses; success; Treatment outcome; treatment program; treatment strategy; Victimization; Woman
Project start date: 2007-08-24
Project end date: 2012-07-31
Budget start date: 1-AUG-2010
Budget end date: 31-JUL-2011
3R01DA021579-04S1 (2011): $146022
TREATMENT STUDY USING DEPOT NALTREXONE(5/6)BALTIMORE PROTOCOL TREATMENT SITE
W Timothy, Senior Research Scientist
Friends Research Institute, Inc.city: Baltimore country: United States (us)
Grant 5R01DA024550-04 from National Institute On Drug Abuse
Abstract: Opioid addiction has remained widespread throughout the United States since the 1960s and a large proportion of users are involved in crimes to support their habits. After release from incarceration, relapse to opioid addiction is very common and this leads to more crimes and re-incarceration. Treatment advances in the area of medications have not reached this population. Effective medications such as methadone and buprenorphine are not well accepted by prosecutors and judges. Permission to conduct research on the most effective treatment approaches is very difficult to obtain for patients under legal restraint because informed consent is problematic. Naltrexone, an opiate receptor antagonist, has demonstrated pharmacological efficacy in preventing relapse to opioid addiction and it has been reported to be clinically effective in parolee populations although it is rarely used. Recently a depot formulation with a one month duration has received FDA approval for the treatment of alcoholism. The purpose of this study is to determine whether a monthly injection of naltrexone is practical and useful in the prevention of relapse and when compared to treatment as usual. We will also monitor HIV risk behaviors to determine whether the intervention reduces risk of HIV and hepatitis C infections. This collaborative project will take place in six treatment sites where there is a large population of parolees with a history of opiate addiction. In order to prevent even a subtle form of coercion, referrals from parole officers will not be accepted. After determining that all volunteers are opiate free by urine test and not currently opiate dependent using a naloxone test, they will be randomized to depot naltrexone or Treatment as Usual (TAU). Participants in both groups will be given identical follow up monthly for six months with measures of opiate use by self-report, urine test and hair analysis. An additional random urine test will take place each month between monthly visits. Both groups will be re-evaluated six and 12 months later. The University of Pennsylvania will be the coordinating site and each site will have a randomization goal of 20 new patients per year over 3.5 to 4 years to accrue a total of 360 to 400 participants. Treatment outcome will be measured by urine tests, hair analysis, self-report and continuation in treatment. Both naltrexone and comparison groups will receive equivalent voucher incentives to remain in the program. A benefit-cost analysis will be conducted to compare the costs of the treatment with the quantifiable benefits in terms of reduced crime, re-incarceration and medical services and increased employment. This project will test the benefits of a new treatment using a depot medication for preventing relapse to opioid addiction. If successful, it will influence the care given to probationers and parolees and likely relieve some of the overcrowding of our prisons. The data from this study can also be used by the FDA to evaluate the benefits of this treatment that could improve the lives of patients suffering from opioid addiction
Keywords: Active Sites; addiction; Address; Agonist; alcohol and other drug; Alcoholism; alcoholism therapy; Area; Authorization documentation; Baltimore; Buprenorphine; caregiving; Chronic; Clinical Treatment; Clinical Trials; Coercion; Communities; comparison group; Control Groups; Controlled Study; cost; Cost-Benefit Analysis; Counseling; Crime; Criminal Justice; Data; data management; Depot Preparation; design; disorder later incidence prevention; Doctor of Medicine; Doctor of Philosophy; Drug abuser; Drug Formulations; Drug Metabolic Detoxication; Drug usage; economic value; Economics; effective therapy; Effectiveness; effectiveness trial; efficacy trial; Employment; Enrollment; Ethical Issues; Ethics; Evaluation; FDA approved; follow-up; Foundations; Friends; Funding; Goals; Habits; Hair; Health; Health Services; Hepatitis C; Hepatitis C Transmission; Heroin; high risk; HIV; Hospitals; Imprisonment; improved; Incentives; Individual; Infection; Informed Consent; Injectable; Injection of therapeutic agent; innovation; Intervention; Intravenous; Legal; Maintenance; Measures; Medical; meetings; Methadone; Monitor; Morbidity - disease rate; Mortality Vital Statistics; Motivation; Naloxone; Naltrexone; Needle Sharing; New York; Online Systems; Opiate Addiction; Opiates; Opioid; Opioid Receptor; Oral; Outcome; Outcome Measure; parole; parolee; Participant; Patient Self-Report; Patients; Pennsylvania; Performance; Persons; Pharmaceutical Preparations; Philadelphia; pilot trial; placebo controlled study; Placebos; Population; prevent; Prisons; probationer; Procedures; Productivity; programs; Protocols documentation; psychosocial; public health medicine (field); Randomized; Recording of previous events; Records; Recruitment Activity; Relapse; Relative (related person); Reporting; Research; Research Institute; restraint; Rhode Island; Risk; Risk Behaviors; Role; Sample Size; Sampling; Services; Site; social; symposium; System; Technology; Testing; treatment as usual; Treatment Cost; treatment effect; Treatment outcome; treatment program; Treatment Protocols; treatment site; United States; Universities; Unsafe Sex; Urine; Virginia; Visit; volunteer; voucher
Project start date: 2008-07-01
Project end date: 2013-05-31
Budget start date: 1-JUN-2011
Budget end date: 31-MAY-2012
PFA/PA: PAR-07-232
5R01DA024550-04 (2011): $279312
DIETARY MANEUVERS TO REDUCE PRODUCTION OF COLON-DERIVED UREMIC SOLUTES
W Timothy, Professor Of Medicine
Palo Alto Institute For Res & Edu, Inc.city: Palo Alto country: United States (us)
Grant 5R21AT005123-02 from National Center For Complementary & Alternative Medicine
Abstract: Hemodialysis prolongs life but does not restore normal health in patients with end stage renal disease. Much of the residual illness suffered by these patients is due to retained "uremic" waste solutes which are not adequately removed by conventional dialysis. Efforts are underway to improve solute removal by increasing the frequency and duration of dialysis treatments. But increasing the number of hours/week on dialysis, even if it affords some benefit, would be both burdensome and costly. This proposal will explore the alternate possibility that uremic solute levels can be lowered by dietary manipulations which reduce solute production. Some potentially important uremic solutes are made in the colon, and the investigators have found that the production of these solutes is greatly reduced in people adhering to a vegetarian diet. Based on this preliminary finding, the investigators propose to test the effect of carefully selected dietary manipulations on solute production in hemodialysis patients. Chemical assays will show whether these manipulations reduce production of the colon-derived uremic solutes p- cresol sulfate, indoxyl sulfate, and dimethylamine. Identification of a dietary treatment that reduced solute production would prompt a follow-up study to test the ability of that treatment to improve health outcomes. The investigators believe that over the long term, diet can compliment dialysis to improve patients´ health without an increase in dialysis time. Conventional hemodialysis prolongs life but does not restore normal health in patients with end stage renal disease. Much of the residual illness suffered by these patients is due to retained waste chemicals which are not adequately removed by current dialysis treatment. This study will assess whether the production of these waste chemicals can be reduced by altering the diet. Finding a dietary change that reduces waste chemical production could provide a means for improving the health of dialysis patients without increasing the time they spend on the dialysis machine
Keywords: base; Biological Assay; Chemicals; Colon; Complement; Cresol; Cresols; Dialysis patients; Dialysis procedure; Diet; dimethylamine; Dimethylamines; Edible Plants; End stage renal failure; Excision; Fiber; follow-up; Frequencies (time pattern); Goals; Health; Hemodialysis; Hour; improved; Indican; Inorganic Sulfates; Intake; Knowledge; Life; Outcome; Patients; Production; public health relevance; Research Personnel; Residual state; solute; Testing; Time; Unspecified or Sulfate Ion Sulfates; Vegetarian diet; wasting
Relevance: Conventional hemodialysis prolongs life but does not restore normal health in patients with end stage renal disease. Much of the residual illness suffered by these patients is due to retained waste chemicals which are not adequately removed by current dialysis treatment. This study will assess whether the production of these waste chemicals can be reduced by altering the diet. Finding a dietary change that reduces waste chemical production could provide a means for improving the health of dialysis patients without increasing the time they spend on the dialysis machine
Project start date: 2010-05-01
Project end date: 2012-04-30
Budget start date: 1-MAY-2011
Budget end date: 30-APR-2012
PFA/PA: PAR-08-135
5R21AT005123-02 (2011): $286468
RESEARCH ETHICS AND SAFETY PROMOTED BY EMBODIED CONVERSATIONAL TECHNOLOGY
W Timothy
Boston Medical Centercity: Boston country: United States (us)
Grant 1R01CA158219-01 from National Cancer Institute
Abstract: Background Despite decades of advocacy to improve informed consent for human subjects, multiple studies have shown that research subjects often do not understand fundamental concepts required for participation. Over the past decade we have developed and tested embodied conversational agents (ECA) - computer characters that simulate face-to-face conversation using voice, hand gesture, gaze cues and other nonverbal behavior in both English and Spanish. We have also pilot tested the use of the ECA platform as a method of supporting the informed consent process for potential research subjects. We now propose to adapt this innovative cutting edge technology to create and test the Research Ethics and Safety Promoted by Embodied Conversational Technology (RESPECT) system which will (1) improve the way potential subjects learn about research studies (ECA-Study Finder); (2) help make informed consent for potential research subjects more meaningful (ECA-Consent Advocate); and (3) improve the experience of research subjects (ECA-Study Buddy). Design Randomized Controlled Trial Hypotheses That RESPECT system participants will (1) have a better study finder experience; (2) have better comprehension of informed consent; (3) be more adherent to the study protocol; and (3) report more adverse events. Population Studied Users of a study finder system and people being approached for enrollment into a set of oncology studies and Boston Medical Center. Methods The ECA-Study Finder will be assessed with a randomized controlled trial of people who use either a text-based or ECA-based study finder system. The ECA-Consent Advocate and ECA-Study Buddy components will be assessed with a randomized controlled trial of 102 patients over 18 years old, who are being approached to participate in an oncology trial at Boston University Medical Center. Outcome Measures The primary outcome is level of comprehension of informed consent. Secondary outcomes for the study finder include accuracy of the text-based versus ECA-based study finder process. Secondary outcomes for the consent advocate include likelihood to enroll and satisfaction. Secondary outcomes for the study-buddy system include adherence to the study protocol, reporting more adverse events, and satisfaction. Expected Results In this project we will evaluate a scalable patient-centered intervention to make it easier for people to search for research studies, improve the quality of informed consent, improve adherence to research protocols, and promote better reporting of adverse events. Despite decades of advocacy to improve informed consent for human subjects, multiple studies have shown that research subjects often do not understand fundamental concepts required for participation. In this project we will advance our research toward the development of a scalable, cost-effective, and sustainable patient-centered Embodied Conversational Technology intervention to make it easier for people to search for research studies, improve the quality of informed consent, improve adherence to research protocols, and promote better reporting of adverse events
Keywords: 18 year old; 21+ years old; Academic Medical Centers; Adherence; Adherence (attribute); Adult; adult human (21+); advanced age; Adverse event; Adverse Experience; Advocacy; Advocate; Aged 65 and Over; American; authority; base; Behavior; Boston; Cancer, Oncology; Cardiopulmonary; City of Boston; Client satisfaction; Clinical Research; Clinical Sciences; Clinical Study; Complex; Comprehension; Computer Systems; Computers; Consent; Consent Documents; Consent Forms; cost effective; Cues; Data; design; designing; Development; eighteen year old; Elderly; Elderly, over 65; elders; Electronics; enroll; Enrollment; Ensure; Ethics; Ethics Committees, Research; Evaluation; experience; experiment; experimental research; experimental study; failure; Failure (biologic function); FLR; gaze; geriatric; Gestures; Hand; Health behavior change; Health education; Health Instruction; health literacy; Health Training; Health Tutoring; Home; Home environment; HOSP; Hospitals; human subject; Human Subject Research; Human, Adult; improved; Informed Consent; Informed Consent Documents; Informed Consent Forms; innovate; innovation; innovative; Institutes; Institution; Institutional Review Boards; Instruction; Intervention; Intervention Strategies; interventional strategy; Investigators; IRBs; late life; later life; Learning; literacy; Literature; Measures; Medical; Medical center; meetings; Methods; older adult; older person; oncology; Outcome Measure; Outcome Study; Participant; patient centered; Patient Education; Patient Instruction; patient oriented; Patient Satisfaction; Patient Training; Patients; Phone; Population Study; primary outcome; Procedures; Process; Protocol; Protocols documentation; public health relevance; randomized controlled study; Randomized Controlled Trials; Readability; Reading; Regulation; Reporting; Research; Research Ethics; Research Ethics Committees; Research Personnel; research study; Research Subjects; Researchers; Safety; satisfaction; screening; Screening procedure; screenings; secondary outcome; senior citizen; Simulate; Structure; Study Subject; System; System, LOINC Axis 4; Technology; Telephone; Testing; Text; translation research enterprise; Translational Research; Translational Research Enterprise; Translational Science; TXT; Universities; University Medical Centers; Voice; Walking; Writing
Relevance: Despite decades of advocacy to improve informed consent for human subjects, multiple studies have shown that research subjects often do not understand fundamental concepts required for participation. In this project we will advance our research toward the development of a scalable, cost-effective, and sustainable patient-centered Embodied Conversational Technology intervention to make it easier for people to search for research studies, improve the quality of informed consent, improve adherence to research protocols, and promote better reporting of adverse events
Project start date: 2011-03-09
Project end date: 2015-12-31
Budget start date: 9-MAR-2011
Budget end date: 31-DEC-2011
PFA/PA: PA-07-277
1R01CA158219-01 (2011): $698720
5R01CA158219-02 (2012): $601818
W Timothy, Senior Research Scientist
Friends Research Institute, Inc.city: Baltimore country: United States (us)
Grant 5R01DA021579-05 from National Institute On Drug Abuse
Keywords: ing; addiction; Address; Adoption; Aftercare; Agonist; base; Buprenorphine; Centers for Disease Control and Prevention (U.S.); Cocaine Abuse; cocaine use; Communities; community based treatment; Community Health Centers; Comprehensive Health Care; Controlled Clinical Trials; Correctional Institutions; Counseling; design; Development; Dose; Drug abuse; early onset; effective therapy; Effectiveness; Employment; Enrollment; experience; Female; France; Gender; Health; Health Services; Health Services Accessibility; Hepatitis B; Hepatitis C; Heroin; Heroin Dependence; high risk; HIV; HIV Infections; HIV Seropositivity; Imprisonment; Individual; Infection; innovation; Institution; Intervention; Maintenance; male; Medical; men; Mental Health; Mental Health Services; Methadone; methadone maintenance; Naloxone; New York City; offender; Opioid; Outcome; Outcome Measure; overdose death; Participant; Pharmaceutical Preparations; Principal Investigator; Prisoner; Prisons; Procedures; programs; Property; Randomized; Recording of previous events; Regulation; Rehabilitation therapy; Relapse; Relative (related person); Research; Research Design; Research Personnel; Risk Behaviors; Safety; Sampling; Security; Services; Sex Characteristics; Sexual abuse; social stigma; Social Welfare; Societies; Spouses; success; Treatment outcome; treatment program; treatment strategy; Victimization; Woman
Project start date: 2007-08-24
Project end date: 2012-07-31
Budget start date: 1-AUG-2011
Budget end date: 31-JUL-2012
5R01DA021579-05 (2011): $459418