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

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.

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.

To review reliability, validity, and normative data from 7 different studies, involving a total of 1,988 people with diabetes, and provide a revised version of the Summary of Diabetes Self-Care Activities (SDSCA) measure. The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. Normative data (means and SD), inter-item and test-retest reliability, correlations between the SDSCA subscales and a range of criterion measures, and sensitivity to change scores are presented for the 7 different studies (5 randomized interventions and 2 observational studies). Participants were typically older patients, having type 2 diabetes for a number of years, with a slight preponderance of women. The average inter-item correlations within scales were high (mean = 0.47), with the exception of specific diet; test-retest correlations were moderate (mean = 0.40). Correlations with other measures of diet and exercise generally supported the validity of the SDSCA subscales (mean = 0.23). There are numerous benefits from standardization of measures across studies. The SDSCA questionnaire is a brief yet reliable and valid self-report measure of diabetes self-management that is useful both for research and practice. The revised version and its scoring are presented, and the inclusion of this measure in studies of diabetes self-management is recommended when appropriate.