Abstract:
:Upstream interventions - e.g. housing programs and community health worker interventions- address socioeconomic and behavioral factors that influence health outcomes across diseases. Studying these types of interventions in clinical trials raises a methodological challenge: how should researchers measure the effect of an upstream intervention in a sample of patients with different diseases? This paper addresses this question using an illustrative protocol of a randomized controlled trial of collaborative-goal setting versus goal-setting plus community health worker support among patients multiple chronic diseases: diabetes, obesity, hypertension and tobacco dependence. At study enrollment, patients met with their primary care providers to select one of their chronic diseases to focus on during the study, and to collaboratively set a goal for that disease. Patients randomly assigned to a community health worker also received six months of support to address socioeconomic and behavioral barriers to chronic disease control. The primary hypothesis was that there would be differences in patients' selected chronic disease control as measured by HbA1c, body mass index, systolic blood pressure and cigarettes per day, between the goal-setting alone and community health worker support arms. To test this hypothesis, we will conduct a stratum specific multivariate analysis of variance which allows all patients (regardless of their selected chronic disease) to be included in a single model for the primary outcome. Population health researchers can use this approach to measure clinical outcomes across diseases. CLINICAL TRIALS REGISTRATION:ClinicalTrials.gov Identifier: NCT01900470.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Kangovi S,Mitra N,Turr L,Huo H,Grande D,Long JAdoi
10.1016/j.cct.2016.12.009subject
Has Abstractpub_date
2017-02-01 00:00:00pages
115-121eissn
1551-7144issn
1559-2030pii
S1551-7144(16)30291-9journal_volume
53pub_type
杂志文章,随机对照试验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:BACKGROUND:Multiple sclerosis is a chronic progressive neurological disease. Evidence attests to the benefits of exercise, guidelines for exercise in multiple sclerosis are available. Remote-delivery of exercise adherence programmes based on the exercise guidelines require urgent testing. AIMS:The design, and outcomes...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2021.106281
更新日期:2021-01-12 00:00:00
abstract:BACKGROUND:Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. METHODS:This 5-site open-...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2015.01.005
更新日期:2015-03-01 00:00:00
abstract:BACKGROUND:There are numerous potential sources of problems when performing complex clinical research trials. These issues are compounded when studies are multi-site and multiple personnel from different sites are responsible for varying actions from case report form design to primary data collection and data entry. M...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2005.11.013
更新日期:2006-04-01 00:00:00
abstract:BACKGROUND:The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute's Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP part...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.08.008
更新日期:2012-11-01 00:00:00
abstract:INTRODUCTION:Cognitive impairment (CI) and cardiovascular disease (CVD) disproportionately affect women compared to men, and CVD increases risk of CI. Physical activity and cognitive training can improve cognition in older adults and may have additive or synergistic effects. However, no combined intervention has target...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106254
更新日期:2020-12-29 00:00:00
abstract::The 2-in-1 adaptive design [Chen et al. 2018] allows seamless expansion of an ongoing Phase 2 trial into a Phase 3 trial to expedite a drug development program. An intermediate endpoint can be used for the adaptive decision. Under a mild assumption that is expected to generally hold in practice, both the Phase 2 trial...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106053
更新日期:2020-08-01 00:00:00
abstract::Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to f...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.06.017
更新日期:2013-09-01 00:00:00
abstract:BACKGROUND:Evidence suggests that periodontitis is associated with prevalent and incident type 2 diabetes mellitus (T2DM), raising the question of whether periodontitis treatment may improve glycemic control in patients with T2DM. Meta-analyses of mostly small clinical trials suggest that periodontitis treatment result...
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.2013.09.010
更新日期:2013-11-01 00:00:00
abstract::We developed a novel diagram to depict patient flow and outcomes in clinical trials. In contrast to flow diagrams such as the CONSORT chart, our diagram enables individual patient histories to be traced and depicts important patterns of treatment administration and outcomes, such as response and adverse events. Also, ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2009.01.010
更新日期:2009-05-01 00:00:00
abstract::Double-blinded trials are often considered the gold standard for research, but significant bias may result from unblinding of participants and investigators. Although the CONSORT guidelines discuss the importance of reporting "evidence that blinding was successful", it is unclear what constitutes appropriate evidence....
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2004.11.020
更新日期:2005-02-01 00:00:00
abstract::The Rare Diseases Clinical Research Network (RDCRN) Contact Registry has grown in size and scope since it was first reported in this journal in 2007. In this paper, we reflect on our seven years' experience developing and expanding the RDCRN Contact Registry to include many more rare diseases. We present the functiona...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.02.012
更新日期:2012-07-01 00:00:00
abstract::There is increasing evidence that exposure of developing brains in animals, including nonhuman primates, to commonly-utilized anesthetic agents may cause adverse effects on cognition and behavior. In this paper, we summarize our methodology for a population-based, propensity-matched study to evaluate possible anesthes...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.12.020
更新日期:2015-03-01 00:00:00
abstract:BACKGROUND:Flaxseed is an important source of alpha-linolenic acid an essential omega-3 fatty acid. The possibility that a supplementation of the diet with foods rich in alpha-linolenic acid, antioxidants and fiber (like flaxseed) has not been investigated. METHODS/DESIGN:The primary objective is to determine whether ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2011.05.005
更新日期:2011-09-01 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::Traditionally, children presenting with appendicitis are referred for urgent appendectomy. Recent improvements in the quality and availability of diagnostic imaging allow for better pre-operative characterization of appendicitis, including severity of inflammation; size of the appendix; and presence of extra-luminal i...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.06.013
更新日期:2019-08-01 00:00:00
abstract:INTRODUCTION:Focal therapy offers the possibility of cancer control, without the side effect profile of radical therapies. Early single centre prospective development studies using high intensity focused ultrasound (HIFU) have demonstrated encouraging genitourinary functional preservation and short-term cancer control....
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2013.06.005
更新日期:2013-09-01 00:00:00
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 intervent...
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.2019.105816
更新日期:2019-09-01 00:00:00
abstract:PURPOSE:African-American women (AAW) are more likely to be metabolically unhealthy than White women (WW). Metabolic syndrome (MetS) is associated with increased breast cancer risk and mortality from breast cancer is greater in AAW compared to WW. Data show MetS affects health-related quality of life (HRQoL). Exercise s...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.02.005
更新日期:2018-04-01 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:INTRODUCTION:The increasing complexities of conducting multiregional trials and an evolving regulatory environment contribute to unprecedented new challenges for use of patient-reported outcome measures (PROMs)(1) within clinical trials. This paper presents these challenges and potential solutions. METHODS:Real-world ...
journal_title:Contemporary clinical trials
pub_type: 临床试验,杂志文章
doi:10.1016/j.cct.2013.02.006
更新日期:2013-05-01 00:00:00
abstract:UNLABELLED:Fatigue is a common and distressing symptom that can last for months or years in up to one-third of cancer survivors. Despite its prevalence, the nature and mechanisms of cancer-related fatigue are poorly understood and the available treatments may not provide sufficient relief. Fatigue has been identified a...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.07.004
更新日期:2016-07-01 00:00:00
abstract:BACKGROUND:With increased internet accessibility worldwide, it is now possible to assemble individuals with rare diseases through web-based patient registries. However, the validity of participant-reported medical diagnoses is unknown. The objective of this study was to evaluate the accuracy of participant-reported Neu...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.12.006
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND:Early pregnancy through the first year of life represents an important period for family health promotion and obesity prevention. Overall, preventive interventions in pregnancy and infancy have insufficiently engaged fathers. We describe the rationale and design of First Heroes, an intervention to improve pe...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106253
更新日期:2020-12-17 00:00:00
abstract:OBJECTIVE:To explore a better administration way through comparison of the pharmacodynamics of cisatracurium administered by continuous infusion or intermittent bolus injection. METHODS:Thirty patients (ASAI-II) who had no neuromuscular disease and underwent selective surgery under general anesthesia were randomly div...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.01.002
更新日期:2012-05-01 00:00:00
abstract:BACKGROUND:This paper reports the protocol of a randomised, double-blind, placebo-controlled study to test the efficacy, safety, and tolerability of lubiprostone (LUB) vs. placebo on suppressing gut permeability in non-alcoholic fatty liver disease (NAFLD) patients with constipation. NAFLD, including non-alcoholic stea...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.04.002
更新日期:2018-06-01 00:00:00
abstract::Foundational elements of lifelong health are formed during the preschool years. Child care attendance has nearly doubled in the past 5 years making child care centers an ideal setting to establish healthy habits that prevent pediatric obesity. Despite the promising evidence of efficacy of child care-based obesity prev...
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.2019.105849
更新日期:2019-11-01 00:00:00
abstract:BACKGROUND:The Fontan circulation is a palliative procedure performed in patients with complex congenital heart disease (CHD), making transpulmonary blood flow dependent on the systemic venous pressure. In a Fontan circulation a low pulmonary vascular resistance (PVR) is crucial, as is epitomized by the observation tha...
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.2011.04.001
更新日期:2011-07-01 00:00:00
abstract::Home-based telemedicine (HBT) is a validated method of evidence-based treatment delivery for posttraumatic stress disorder (PTSD), and justification for its use has centered on closing gaps related to provider availability and distance to treatment centers. However, another potential use of HBT may be to overcome barr...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.03.004
更新日期:2016-05-01 00:00:00
abstract::A response-adaptive randomization (RAR) design refers to the method in which the probability of treatment assignment changes according to how well the treatments are performing in the trial. Holding the promise of treating more patients with the better treatments, RARs have been successfully implemented in clinical tr...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.11.006
更新日期:2015-01-01 00:00:00