Abstract:
BACKGROUND:Despite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance. METHODS:Forty-eight mental health provider organizations from across the United States will be recruited to participate in the trial. The evidence-based practice to be implemented is the InSHAPE health promotion intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The primary outcomes are InSHAPE program participation and fidelity, and participant weight loss; secondary outcomes are program operation, program uptake, participant health behaviors of physical activity and nutrition, organizational change, and program sustainment. Implementation outcomes are measured at 3, 6, 12, 18, and 24 months after the program start-up. Participant-level outcomes are measured at fixed intervals every 3 months after each participant enrolls in the study. DISCUSSION:This study will determine whether VLCs are an effective implementation strategy among resource-limited providers when the new practice necessitates a shift in mission, scope of practice, type of services delivered, and new financing. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT03891368 Registered 25 March 2019, retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03891368?term=NCT03891368&rank=1.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Aschbrenner KA,Pratt SI,Bond GR,Zubkoff L,Naslund JA,Jue K,Williams G,Kinney A,Cohen MJ,Godfrey MM,Bartels SJdoi
10.1016/j.cct.2019.105816subject
Has Abstractpub_date
2019-09-01 00:00:00pages
105816eissn
1551-7144issn
1559-2030pii
S1551-7144(19)30247-2journal_volume
84pub_type
杂志文章,多中心研究,随机对照试验abstract::Major depressive disorder (MDD) is the most common mental illness and the leading cause of disability worldwide. Electroconvulsive therapy (ECT) is the most effective treatment for MDD and the gold-standard therapy for treatment-resistant depression (TRD), yet it remains underutilized due to factors such as limited av...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.12.009
更新日期:2019-02-01 00:00:00
abstract::The most relevant randomized controlled trials of interferon-alpha (IFN) for naive patients with chronic hepatitis C (CHC) published in a decade, just before appearance of pegylated IFN trials in 2000, were included in this paper. Its purpose is to review the relationship between sustained biochemical response in acti...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,meta分析
doi:10.1016/j.cct.2004.12.009
更新日期:2005-04-01 00:00:00
abstract::The Ready Steady 3.0 trial is designed to test the main and interactive effects of two behavior change intervention components, within an 8-week physical activity intervention, on older adults' physical activity (PA). Each component is comprised of behavior change strategies that emphasize two different evidence-based...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106238
更新日期:2020-12-05 00:00:00
abstract:OBJECTIVE:Endometriosis is a chronic, estrogen dependent condition that affects 5-10% of reproductive aged women and is associated with pelvic pain and infertility. As the approach to therapy shifts from surgical ablation to pharmacological control, a non-surgical mode of diagnosis would be desirable. The ENDOmarker st...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2018.03.002
更新日期:2018-05-01 00:00:00
abstract::Several randomized trials have found behavior change programs delivered via text messaging to be efficacious to improve preventive health behaviors such as physical activity and stopping smoking; however few have assessed its value in skin cancer prevention or early detection. The HealthyTexts study enrolled 678 parti...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.03.009
更新日期:2013-05-01 00:00:00
abstract:UNLABELLED:Despite short-term efficacy, many weight loss studies demonstrate poor long-term results and have difficulty recruiting men. Cost-effective treatments that help men achieve long-term weight loss are required. Using a two-phase, assessor-blinded, parallel-group randomised controlled trial design this study wi...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.11.004
更新日期:2014-01-01 00:00:00
abstract:PURPOSE:The aims of the study protocol are to investigate different adapted physical training programs in patients with advanced lung cancer undergoing palliative chemo- or radiotherapy and to evaluate their effects on physical performance, quality of life, symptom burden, and efficacy of oncologic treatment. METHODS:...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.11.013
更新日期:2014-01-01 00:00:00
abstract:BACKGROUND:The comprehension of informed consent is an integral part of clinical trials. Though India is rapidly becoming a hub of clinical trials very few studies have dealt with the issue of comprehension of informed consent by the patients participating in these trials. METHODS:Patients who were invited to particip...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2009.03.005
更新日期:2009-09-01 00:00:00
abstract::Physical therapy (PT) is a key component of treatment for knee osteoarthritis (OA) and can decrease pain and improve function. Given the expected rise in prevalence of knee OA and the associated demand for treatment, there is a need for models of care that cost-effectively extend PT services for patients with this con...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.12.007
更新日期:2013-03-01 00:00:00
abstract:BACKGROUND:Basic research suggests that rapid increases in circulating inflammatory and hemostatic blood markers may trigger or indicate impending plaque rupture and coronary thrombosis, resulting in acute ischemic heart disease (IHD) events. However, these associations are not established in humans. METHODS AND RESUL...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.03.009
更新日期:2014-05-01 00:00:00
abstract::Although colorectal cancer (CRC) is largely preventable through identification of pre-cancerous polyps through various screening modalities, morbidity and mortality rates remain a challenge, especially in African-American, Latino, low-income and uninsured/underinsured patients. Barriers to screening include cost, acce...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2016.11.009
更新日期:2017-01-01 00:00:00
abstract:OBJECTIVE:To retrospectively analyze the effects of long-acting gonadotropin-releasing hormone agonist (GnRH-a) combined with transvaginal ultrasound-guided cyst aspiration on the pregnancy outcomes of in vitro fertilization-embryo transfer (IVF-ET) in the infertile patients with ovarian endometriosis. METHODS:The 134...
journal_title:Contemporary clinical trials
pub_type: 临床试验,杂志文章
doi:10.1016/j.cct.2012.07.009
更新日期:2012-11-01 00:00:00
abstract:BACKGROUND:Bipolar Disorder (BD) is a common and severe form of mental illness. Pharmacotherapy is the main treatment offered, but has limited effectiveness, and there is increasing evidence that people with BD respond well to psychological interventions. Inequalities in access to face-to-face psychological interventio...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.02.011
更新日期:2012-07-01 00:00:00
abstract:BACKGROUND:Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk coun...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2017.02.009
更新日期:2017-05-01 00:00:00
abstract::Clinical trial is considered a breakthrough method in medicine and essential to the development of new drugs. Clinical trials that comply with international and national regulations require an appropriate infrastructure and team qualification. The goal of this study was to evaluate clinical trial groups in Brazil: pro...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2010.06.002
更新日期:2010-09-01 00:00:00
abstract::Prostate cancer is a slow progressing cancer that affects millions of men in the US. Due to uncertainties in outcomes and treatment complications, it is important that patients engage in informed decision making to choose the "optimal treatment". Patient centered care that encompasses informed decision-making can impr...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2015.09.024
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:Individuals with serious mental illness (SMI) smoke at disproportionately higher rates than those without SMI, have lifespans 25-32 years shorter, and thus bear an especially large burden of tobacco-related morbidity and mortality. Several recent studies demonstrate that smokers with SMI can successfully qui...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.06.001
更新日期:2019-08-01 00:00:00
abstract::Patients with malignant disease enrolled in trials of thrombotic disorders may experience competing events such as death. The occurrence of a competing event may prevent the thrombotic event from being observed. Standard survival analysis techniques ignore competing risks, resulting in possible bias and distorted infe...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2011.07.005
更新日期:2011-11-01 00:00:00
abstract::Since its introduction in 1974 the use of the term Minimization has been broadened to include other algorithms. All algorithms use patient characteristics to determine the assignment that produces the best overall balance between treatment groups. They differ in whether or not they use all of the data from each previo...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.cct.2009.12.005
更新日期:2010-03-01 00:00:00
abstract:BACKGROUND:The Covid-19 pandemic has caused fear and panic worldwide, forcing healthcare systems to disregard conventional practices and adopt innovation to contain the infection and death. Globally, there has been a rapid proliferation of research studies and clinical trials assessing risks, infectivity and treatment....
journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
doi:10.1016/j.cct.2020.106106
更新日期:2020-09-01 00:00:00
abstract::Dyslipidemia and insulin resistance occur in a large proportion of HIV-infected patients treated with highly active antiretroviral therapy (HAART); anthropomorphic changes, such as lipoatrophy and central obesity, occur in a subset of patients. This cluster of clinical features, which is termed HIV lipodystrophy, plac...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2006.07.002
更新日期:2006-12-01 00:00:00
abstract:BACKGROUND:The FEVER (Frail Elderly Vibration Exercise Response) study aims to address a paucity of research focusing on the use of Whole Body Vibration (WBV) by frail elderly who, with the highest levels of dependence and fall-related hospitalisation/mortality, potentially stand to benefit most from such accessible ex...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2015.08.008
更新日期:2015-09-01 00:00:00
abstract::Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Br...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2016.06.005
更新日期:2016-07-01 00:00:00
abstract:BACKGROUND:Extant obesity efforts have had a limited impact among low-income underserved children, in part because existing programs are limited in terms of their short duration and low dosage, limited accessibility and sustainability; and failure to address barriers faced by diverse low-income families. METHODS:This ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.12.010
更新日期:2019-02-01 00:00:00
abstract::Although therapeutic treatments exist for substance use disorder (SUD), about half of individuals who enter treatment leave early and relapse to substance use. Early dropout from residential treatment places individuals at risk of relapse, and women in SUD residential treatment represent a vulnerable population. Evide...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.09.004
更新日期:2017-11-01 00:00:00
abstract::Assessing the probability that a Phase III clinical trial will demonstrate clinically relevant efficacy based on Phase II data is an important topic in clinical drug development. An accurate estimate of how likely a Phase III trial will succeed based on available data will inform the decision on whether to move an exp...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2010.08.008
更新日期:2010-11-01 00:00:00
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 a...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.04.002
更新日期:2012-07-01 00:00:00
abstract:INTRODUCTION:Cardiac rehabilitation (CR) programs reduce overall and cardiovascular mortality in patients with a history of acute coronary events or revascularization procedures, but only 30% of patients enroll in CR and attrition rates reach up to 60%. Tai chi, a mind-body practice based on light/moderate aerobic exer...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2015.06.020
更新日期:2015-07-01 00:00:00
abstract:INTRODUCTION:In rural America cigarette smoking is prevalent, few cessation services are available, and healthcare providers lack the time and resources to help smokers quit. This paper describes the design and participant characteristics of Connect2Quit (C2Q), a randomized control trial (RCT) that tests the effectiven...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2014.04.008
更新日期:2014-07-01 00:00:00
abstract:BACKGROUND:Research demonstrates a link between migraine and obesity. Obesity increases the risk of frequent migraines and is associated with migraine prevalence among reproductive-aged women. These findings are substantiated by several plausible mechanisms and emerging evidence of migraine improvements after surgical ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.03.004
更新日期:2013-05-01 00:00:00