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      The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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            Brief questions to identify patients with inadequate health literacy.

            No practical method for identifying patients with low heath literacy exists. We sought to develop screening questions for identifying patients with inadequate or marginal health literacy. Patients (n=332) at a VA preoperative clinic completed in-person interviews that included 16 health literacy screening questions on a 5-point Likert scale, followed by a validated health literacy measure, the Short Test of Functional Health Literacy in Adults (STOHFLA). Based on the STOFHLA, patients were classified as having either inadequate, marginal, or adequate health literacy. Each of the 16 screening questions was evaluated and compared to two comparison standards: (1) inadequate health literacy and (2) inadequate or marginal health literacy on the STOHFLA. Fifteen participants (4.5%) had inadequate health literacy and 25 (7.5%) had marginal health literacy on the STOHFLA. Three of the screening questions, "How often do you have someone help you read hospital materials?" "How confident are you filling out medical forms by yourself?" and "How often do you have problems learning about your medical condition because of difficulty understanding written information?" were effective in detecting inadequate health literacy (area under the receiver operating characteristic curve of 0.87, 0.80, and 0.76, respectively). These questions were weaker for identifying patients with marginal health literacy. Three questions were each effective screening tests for inadequate health literacy in this population.
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              The Look AHEAD study: a description of the lifestyle intervention and the evidence supporting it.

              The Look AHEAD (Action for Health in Diabetes) study is a multicenter, randomized controlled trial designed to determine whether intentional weight loss reduces cardiovascular morbidity and mortality in overweight individuals with type 2 diabetes. The study began in 2001 and is scheduled to conclude in 2012. A total of 5145 participants have been randomly assigned to a lifestyle intervention or to an enhanced usual care condition (i.e., diabetes support and education). This article describes the lifestyle intervention and the empirical evidence to support it. The two principal intervention goals are to induce a mean loss >or = 7% of initial weight and to increase participants' moderately intense physical activity to > or =175 min/wk. For the first 6 months, participants attend one individual and three group sessions per month and are encouraged to replace two meals and one snack a day with liquid shakes and meal bars. From months 7 to 12, they attend one individual and two group meetings per month and continue to replace one meal per day (which is recommended for the study's duration). Starting at month 7, more intensive behavioral interventions and weight loss medication are available from a toolbox, designed to help participants with limited weight loss. In Years 2 to 4, treatment is provided mainly on an individual basis and includes at least one on-site visit per month and a second contact by telephone, mail, or e-mail. After Year 4, participants are offered monthly individual visits. The intervention is delivered by a multidisciplinary team that includes medical staff who monitor participants at risk of hypoglycemic episodes.
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                Author and article information

                Journal
                Contemporary Clinical Trials
                Contemporary Clinical Trials
                Elsevier BV
                15517144
                September 2020
                September 2020
                : 96
                : 106080
                Article
                10.1016/j.cct.2020.106080
                © 2020

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