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Objective To describe the methodology of a 2-arm randomized controlled trial that compared the effects of a narrative and didactic version of the Witness CARES (Community Awareness, Reach, & Empowerment for Screening) intervention on colorectal cancer screening behavior among African Americans, as well as the cognitive and affective determinants of screening. Methods Witness CARES targeted cognitive and affective predictors of screening using a culturally competent, community-based, narrative or didactic communication approach. New and existing community partners were recruited in two New York sites. Group randomization allocated programs to the narrative or didactic arm. Five phases of data collection were conducted: baseline, post-intervention, three-month, six-month, and qualitative interviews. The primary outcome was screening behavior; secondary outcomes included cognitive and affective determinants of screening. Results A total of 183 programs were conducted for 2655 attendees. Of these attendees, 19.4% ( N = 516) across 158 programs (50% narrative; 50% didactic) were study-eligible and consented to participate. Half (45.6%) of the programs were delivered to new community partners and 34.8% were delivered at faith-based organizations. Mean age of the total sample was 64.7 years and 75.4% were female. Conclusion The planned number of programs was delivered, but the proportion of study-eligible attendees was lower than predicted. This community-based participatory research approach was largely successful in involving the community served in the development and implementation of the intervention and study. [ABSTRACT FROM AUTHOR]

Background Patients who are better informed and more engaged in their health care have higher satisfaction with health care and better health outcomes. While patient engagement has been a focus in the outpatient setting, strategies to engage inpatients in their care have not been well studied. We are undertaking a study to assess how patients' information needs during hospitalization can be addressed with health information technologies. To achieve this aim, we developed a personalized inpatient portal that allows patients to see who is on their care team, monitor their vital signs, review medications being administered, review current and historical lab and test results, confirm allergies, document pain scores and send questions and comments to inpatient care providers. The purpose of this paper is to describe the protocol for the study. Methods/design This pragmatic randomized controlled trial will enroll 426 inpatient cardiology patients at an urban academic medical center into one of three arms receiving: 1) usual care, 2) iPad with general internet access, or 3) iPad with access to the personalized inpatient portal . The primary outcome of this trial is patient engagement, which is measured through the Patient Activation Measure. To assess scalability and potential reach of the intervention, we are partnering with a West Coast community hospital to deploy the patient engagement technology in their environment with an additional 160 participants. Conclusion This study employs a pragmatic randomized control trial design to test whether a personalized inpatient portal will improve patient engagement. If the study is successful, continuing advances in mobile computing technology should make these types of interventions available in a variety of clinical care delivery settings. [ABSTRACT FROM AUTHOR]

Purpose of the research: There is increasing interest in including measures of biological mechanisms as mediators and moderators of treatment outcome in randomized controlled trials (RCT's) of psychotherapy efficacy. However, examining biological mechanisms is often expensive and budget caps of most major funding agencies have remained stable in recent years. The goal of this manuscript is to describe how a psychotherapy efficacy trial is using a model of collaborative, affiliated grants to maximize resources and the potential knowledge to be gained from a single site RCT. Principal results and conclusions: The trial is an ongoing RCT comparing two psychotherapies for the treatment of concurrent posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) with a sample of treatment seeking veterans. Through collaboration with a team of investigators with independently-funded but affiliated grants, measures of select sleep, neurobiological, and genetic biomarkers were integrated into this single site RCT. This model has allowed us to pose research questions regarding the role of biological mechanisms, maximize the utility of recruitment, and be efficient in maximizing knowledge to be gained in a way that would not be possible solely on the funding of a single site RCT. Challenges of this model include high participant burden in regard to assessment and complicated coordinating procedures among studies. Strategies to address these challenges are described. [ABSTRACT FROM AUTHOR]

Population aging is associated with a higher prevalence of chronic health conditions. Previous studies have shown that older persons, specifically those with chronic conditions, often lack sufficient knowledge about their condition and thus frequently have poor self-care skills. Efforts to increase general health screenings and improve access to chronic condition management resources are hampered by a lack of disease and health awareness. Self-Care for Older People (SCOPE) study, a cluster randomized controlled trial in Singapore, was designed to evaluate the impact of a self-care program for chronic disease awareness and management of specific health measures and quality of life of older people over eighteen months. SCOPE provided self-care education targeted at older people with low income and low education in order to improve health-related knowledge. A total of 378 low-income older people with no or minimal disability, defined as having difficulty in one or more activities of daily living (ADL), were recruited from senior activity centers. The measurements taken included self-reported health conditions, health and disease knowledge questions, and biomarkers (HbA1c, blood pressure, peak expiratory flow, lipid panel, albumin, and creatinine). SCOPE was also designed to provide information for policy makers on chronic disease burden and healthcare facility utilization among community-dwelling older adults. Trial Registration Number: NCT01672177 . [ABSTRACT FROM AUTHOR]

Background Obesity is a major health problem that disproportionately affects Black and Hispanic adults. This paper presents the rationale and innovative design of a small change eating and physical activity intervention (SC) combined with a positive affect and self-affirmation (PA/SA) intervention versus the SC intervention alone for weight loss. Methods Using a mixed methods translational model (EVOLVE), we designed and tested a SC approach intervention in overweight and/ or obese African American and Hispanic adults. In Phase I, we explored participant’s values and beliefs about the small change approach. In Phase II, we tested and refined the intervention and then, in Phase III we conducted a RCT. Participants were randomized to the SC approach with PA/SA intervention vs. a SC approach alone for 12 months. The primary outcome was clinically significant weight loss at 12 months. Results Over 4.5 years a total of 574 participants (67 in Phase I, 102 in Phase II and 405 in Phase III) were enrolled. Phase I findings were used to create a workbook based on real life experiences about weight loss and to refine the small change eating strategies. Phase II results shaped the recruitment and retention strategy for the RCT, as well as the final intervention. The RCT results are currently under analysis. Conclusion The present study seeks to determine if a SC approach combined with a PA/SA intervention will result in greater weight loss at 12 months in Black and Hispanic adults compared to a SC approach alone. [ABSTRACT FROM AUTHOR]

Rationale The management of perioperative period for patients with spontaneous intracerebral hemorrhage affects the prognosis. Elevated blood pressure is common in the patients with spontaneous intracerebral hemorrhage and related to a poor outcome. However, study on antihypertensive treatment for surgical patients with spontaneous intracerebral hemorrhage is insufficient. Aims To determine if the intensive antihypertensive treatment improves the prognosis compared with the conservative antihypertensive treatment followed guidelines in perioperative period for patients with spontaneous intracerebral hemorrhage. Design PATICH is a prospective, parallel, randomized, assessor-blinded trial. Two hundred eligible patients will be assigned to the intensive group and conservative group randomly. Patients allocated to the intensive group will receive an intensive antihypertensive treatment aiming to achieve a target systolic blood pressure of between 120 mm Hg and 140 mm Hg while the patients in the conservative group will receive conservative antihypertensive treatment as recommended by guidelines for 7 days. Operation will be conducted by well-trained surgeons and the best medical treatment will be given in all patients. Patients will be followed up at 7 days, 30 days, and 90 days. Study outcomes Primary outcome of this study is the rate of rehemorrhage in 7 days after surgery. Secondary outcomes include death and dependency at 90 days incidence of ischemic stroke, separate rate of death and dependency at 90 days, health related quality of life (HRQoL) at 90 days, incidence of other vascular events, and days of hospitalization. Dependency is defined by a score of 3–5 based on the modified Rankin Scale (mRS). [ABSTRACT FROM AUTHOR]

Abstract: High consumption of sugar-sweetened beverages (SSB) contributes to a wide range of poor health outcomes. Further, few US adults drink less than the recommended ≤8oz per day; and individuals with low socioeconomic, low health literacy status, and in rural areas are even less likely to meet recommendations. Unfortunately, few SSB behavioral interventions exist targeting adults, and none focus on low health literacy in rural areas. Talking Health, a type 1 effectiveness-implementation hybrid trial targeting adults in rural southwest Virginia, was developed using the RE-AIM planning and evaluation framework (reach, effectiveness, adoption, implementation, maintenance). The primary aim of this pragmatic randomized-controlled trial was to determine the effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption (SIPsmartER) when compared to a matched contact physical activity promotion control group (MoveMore). SIPsmartER was developed based upon the Theory of Planned Behavior and uses health literacy strategies to improve comprehension of the intervention content among participants. MoveMore is based on a research-tested intervention that was adapted to address all theory of planned behavior constructs and health literacy principles. Secondary aims include additional health outcomes (e.g., physical activity, weight) and reach, adoption, implementation, and maintenance indicators. This paper highlights the opportunities and considerations for developing health behavior trials that aim to determine intervention effectiveness, provide all study participants an opportunity to benefit from research participation, and collect key information on reach and the potential for organizational adoption, implementation, and maintenance with the longer-term goal of speeding translation into practice settings. [Copyright &y& Elsevier]

Abstract: Prolonged exposure (PE) therapy is considered a gold standard protocol for the treatment of PTSD, and it is associated with large treatment effect sizes in combat veteran samples. However, considering high rates of PTSD in the present veteran population, ongoing research work is important toward improving treatment efficiency by decreasing time to symptom amelioration and increasing the amount of symptom amelioration. The proposed research aims to enhance exposure therapy outcomes for veterans with PTSD via combination treatment with PE and yohimbine hydrochloride (HCL), an alpha-2 adrenergic receptor antagonist. The proposed investigation entails a randomized, placebo-controlled trial investigating the effect of a single administration of yohimbine HCL (paired with the first session of imaginal exposure) on outcome of PE in 40 veterans with PTSD. An additional goal is to establish a pragmatic method of tracking psychophysiological measures over the course of therapy for incorporation into future clinical psychotherapy trials. Thus, in addition to traditional self- and clinician-reported psychological outcomes, heart rate and skin conductance reactivity will be measured during a standard trauma-specific imagery task before, during, and after PE treatment. We will further investigate whether changes in psychophysiological measures predict changes in patient- and clinician-reported outcome measures. [Copyright &y& Elsevier]

Abstract: Introduction: Robotic assistance during laparoscopic surgery for pelvic organ prolapse rapidly disseminated across the United States without level I data to support its benefit over traditional open and laparoscopic approaches [1]. This manuscript describes design and methodology of the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS) Trial. Methods: ACCESS is a randomized comparative effectiveness trial enrolling patients at two academic teaching facilities, UCLA (Los Angeles, CA) and Loyola University (Chicago, IL). The primary aim is to compare costs of robotic assisted versus pure laparoscopic abdominal sacrocolpopexy (RASC vs LASC). Following a clinical decision for minimally-invasive abdominal sacrocolpopexy (ASC) and research consent, participants with symptomatic stage≥II pelvic organ prolapse are randomized to LASC or RASC on the day of surgery. Costs of care are based on each patient''s billing record and equipment costs at each hospital. All costs associated with surgical procedure including costs for robot and initial hospitalization and any re-hospitalization in the first 6weeks are compared between groups. Secondary outcomes include post-operative pain, anatomic outcomes, symptom severity and quality of life, and adverse events. Power calculation determined that 32 women in each arm would provide 95% power to detect a $2500 difference in total charges, using a two-sided two sample t-test with a significance level of 0.05. Results: Enrollment was completed in May 2011. The 12-month follow-up was completed in May 2012. Conclusions: This is a multi-center study to assess cost as a primary outcome in a comparative effectiveness trial of LASC versus RASC. [Copyright &y& Elsevier]

Abstract: Depression affects 20–30% of people living with HIV/AIDS (PLWHA) in the U.S. and predicts greater sexual risk behaviors, lower antiretroviral (ARV) medication adherence, and worse clinical outcomes. Yet little experimental evidence addresses the critical clinical question of whether depression treatment improves ARV adherence and clinical outcomes in PLWHA with depression. The Strategies to Link Antidepressant and Antiretroviral Management at Duke, UAB, and UNC (SLAM DUNC) Study is a randomized clinical effectiveness trial funded by the National Institute for Mental Health. The objective of SLAM DUNC is to test whether a depression treatment program integrated into routine HIV clinical care affects ARV adherence. PLWHA with depression (n=390) are randomized to enhanced usual care or a depression treatment model called Measurement-Based Care (MBC). MBC deploys a clinically supervised Depression Care Manager (DCM) to provide evidence-based antidepressant treatment recommendations to a non-psychiatric prescribing provider, guided by systematic and ongoing measures of depressive symptoms and side effects. MBC has limited time requirements and the DCM role can be effectively filled by a range of personnel given appropriate training and supervision, enhancing replicability. In SLAM DUNC, MBC is integrated into HIV care to support HIV providers in antidepressant prescription and management. The primary endpoint is ARV adherence measured by unannounced telephone-based pill counts at 6months with follow-up to 12months and secondary endpoints including viral load, health care utilization, and depressive severity. Important outcomes of this study will be evidence of the effectiveness of MBC in treating depression in PLWHA and improving HIV-related outcomes. [Copyright &y& Elsevier]

Abstract: Testosterone levels decrease with age. This decline is steeper during “critical illnesses”. Cardiac surgery is a particular representative model of major clinical condition producing stress responses similar to those observed during severe nonsurgical illness. Cardiac revascularization with extracorporeal circulation is characterized by marked postoperative complications such as insulin resistance, a pro-inflammatory state, acute anemia and renal dysfunction. These phenomena are more evident in older subjects, who are particularly vulnerable in the post-operative state, a condition that has been recently termed as “acute postoperative frailty”. We recently showed that in older men with low ejection fraction undergoing cardiac revascularization with extracorporeal circulation, there is a profound decline in anabolic hormones, including testosterone. After surgery testosterone concentration frequently declines to less than 200ng/dl, a situation suggestive of overt hypogonadism. Since men with low testosterone levels have a high probability of developing mobility limitations, we considered this a rationale for the perioperative use of testosterone treatment in older men undergoing cardiac revasularization surgery. We hypothesized that testosterone supplementation at this time might attenuate the impressive post-surgical catabolic hormonal milieu. The aim of this manuscript is to elucidate an ongoing randomized clinical trial in older men (70+ years old) undergoing elective cardiovascular revascularization with extracorporeal circulation. This randomized clinical trial will evaluate the effects of intramuscular testosterone administration on clinical and functional outcomes in this population. The study will also address potential mechanisms underlying the expected beneficial effects of testosterone supplementation including improvement of insulin sensitivity, markers of inflammatory status and improved hemoglobin levels. [Copyright &y& Elsevier]

Abstract: There is growing interest in promoting health for people with disabilities, yet evidence regarding community-based interventions is sparse. This paper describes the design details of a randomized controlled trial (RCT) that will test the effectiveness of a multi-component behaviorally based, intervention to promote exercise adoption (over 6months) and maintenance (up to one year) among wheelchair users and includes descriptive data on participant characteristics at baseline. Participants were randomly assigned to either a staff-supported intervention group or a self-guided comparison group. The primary study aim is to assess the effectiveness of the multi-component behaviorally based intervention for promoting physical activity adoption and maintenance. The RCT will also assess the physical and psychosocial effects of the intervention and the complex interplay of factors that influence the effectiveness of the intervention. Therefore, the primary outcome derives from participant reports of weekly exercise (type, frequency, duration) over 52weeks. Secondary outcomes collected on four occasions (baseline, 3months, 6months, 12months) included physiological outcomes (VO2 peak, strength), disability-related outcomes (pain, fatigue, participation), and psychosocial outcomes (exercise self-efficacy, exercise barriers, quality of life, depression, mood). This study will provide evidence regarding the effectiveness of a multi-component behaviorally based intervention for promoting exercise adoption among people with mobility impairments that necessitate wheelchair use. [Copyright &y& Elsevier]

Abstract: Introduction:: Psychological theory suggests that participants may be more likely to volunteer to join a clinical trial if they perceive places in the trial are a scarce commodity. Material and methods:: We conducted a single blind, randomized controlled trial to test recruitment strategies within the larger txt2stop smoking cessation trial. 1862 people who were eligible for the txt2stop trial but had not yet consented to join were randomized to receive either A) a reminder about the txt2stop trial plus a message that there were only 300 places left, or B) a reminder about the trial only. The outcome was the participant''s consent to join the txt2stop trial 3days after messages were sent. Results: Of 895 participants randomized to the intervention group, 90 (10.1%) had consented to join the txt2stop trial. Of the 967 participants randomized to the control group, 67 (6.9%) had consented to join the txt2stop trial (OR=1.50, 95% CI 1.07–2.12). Discussion: Scarcity messages were an effective way to increase recruitment into the txt2stop trial and could be relevant to other trials. Conclusions: Communicating scarcity is an effective way to increase trial recruitment. [Copyright &y& Elsevier]

Abstract: Although the Diabetes Prevention Program (DPP) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals, it has yet to be widely adopted at the community level. The Healthy Living Partnership to Prevent Diabetes study (HELP PD) was designed to translate the DPP approach for use in community settings as a cost-effective intervention led by Community Health Workers (CHW''s) and administered through a Diabetes Care Center (DCC). Approximately 300 overweight and obese (BMI 25-40kg/m2) individuals with prediabetes (fasting blood glucose 95-124mg/dl) were randomly assigned to either a lifestyle weight loss intervention (LW) or an enhanced usual care comparison condition (UC). The goal of LW is ≥7% weight loss achieved through increases in physical activity (180min/wk) and decreases in caloric intake (approximately 1500kcal/day). The intervention consists of CHW-led group-mediated cognitive behavioral meetings that occur weekly for 6months and monthly thereafter for 18months. UC consists of 2 individual meetings with a registered dietitian and a monthly newsletter. The primary outcome is change in fasting blood glucose. Secondary outcomes include cardiovascular risk factors, health-related quality of life, and social cognitive variables. Outcomes are masked and are collected every 6months. The cost-effectiveness of the program will also be assessed. A community-based program that is administered through local DCC''s and that harnesses the experience of community members (CHW''s) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals. [Copyright &y& Elsevier]

Abstract: Background : Nonalcoholic fatty liver disease (NAFLD) in children can lead to steatohepatitis, cirrhosis, and end-stage liver disease. The cause of NAFLD is unknown, but it is commonly associated with obesity, insulin resistance, and dyslipidemia. Objectives : TONIC is conducted to test whether treatment with metformin, an insulin sensitizer, or vitamin E, a naturally available antioxidant, will lead to improvements in biochemical and histological features of nondiabetic children with biopsy-proven NAFLD. Design : TONIC is a randomized, multicenter, double-masked, placebo-controlled trial of 96weeks of treatment with metformin or vitamin E. The primary outcome measure chosen for the trial is improvement in serum alanine aminotransferase (ALT) levels with treatment as compared to placebo. An improvement in ALT is defined as reduction in serum ALT levels to below 50% of the baseline values or into the normal range (40U/L or less) during the last 48weeks of treatment. Histological improvement is defined by changes in liver histology between a baseline and end-of-treatment liver biopsy in regards to (1) steatohepatitis, (2) NAFLD Activity Score, consisting of scores for steatosis, lobular inflammation, and hepatocellular injury (ballooning), and (3) fibrosis score. Methods : Between September 2005 and September 2007, 173 children were enrolled into TONIC at 10 clinical centers in the United States. Participants were randomized to receive either metformin (500mg b.i.d.), vitamin E (400IU b.i.d.), or placebo for 96weeks. This protocol was approved by all participating center Institutional Review Boards (IRBs) and an independent Data and Safety Monitoring Board (DSMB). (ClinicalTrials.gov number, NCT00063635.) [Copyright &y& Elsevier]

Abstract: In clinical trials of systemic therapy for advanced hepatocellular carcinoma (HCC), Asian trials almost always reported poorer survival than non-Asian trials. This study sought to identify contributory factors for this geographic difference. A systematic review was done on randomized trials for unresectable HCC that used systemic therapy as an experimental arm and placebo or supportive care as control. Meta-analysis was performed with the consideration of fixed and random effects. Then, meta-regression was performed to identify predictors of patient survival in the control arm and the treatment effects (improvement in median survival). Fourteen trials (6 Asians, 8 non-Asians) were eligible for meta-analysis. The median survival of patients in the control arm, which indicated natural history of advanced HCC patients, was 3.57±1.88months in Asian trials and 5.96±1.46months in non-Asian trials (p =0.02). Independent predictors of better survival included non-Asian trials (p =0.0007), higher percentage of Child A cirrhosis (p =0.01) and hepatitis B (HBV)-related HCC (p =0.02). Sub-group analysis suggested that Asian trials tended to enroll patients with more advanced diseases. Independent predictors of better treatment effect included non-Asian trials, higher percentage of extra-hepatic metastasis, HBV-related HCC, and poorer trial quality. The quantitative estimation of the geographic difference can help design of future clinical trials of advanced HCC. [Copyright &y& Elsevier]