The value of self-monitoring of blood glucose (SMBG) levels in patients with non-insulin-treated type 2 diabetes has been debated. OBJECTIVE To compare 3 approaches of SMBG for effects on hemoglobin A 1c levels and health-related quality of life (HRQOL) among people with non-insulin-treated type 2 diabetes in primary care practice. DESIGN, SETTING, AND PARTICIPANTS The Monitor Trial study was a pragmatic, open-label randomized trial conducted in 15 primary care practices in central North Carolina. Participants were randomized between January 2014 and July 2015. Eligible patients with type 2 non-insulin-treated diabetes were: older than 30 years, established with a primary care physician at a participating practice, had glycemic control (hemoglobin A 1c) levels higher than 6.5% but lower than 9.5% within the 6 months preceding screening, as obtained from the electronic medical record, and willing to comply with the results of random assignment into a study group. Of the 1032 assessed for eligibility, 450 were randomized. INTERVENTIONS No SMBG, once-daily SMBG, and once-daily SMBG with enhanced patient feedback including automatic tailored messages delivered via the meter. MAIN OUTCOMES AND MEASURES Coprimary outcomes included hemoglobin A 1c levels and HRQOL at 52 weeks. RESULTS A total of 450 patients were randomized and 418 (92.9%) completed the final visit. There were no significant differences in hemoglobin A 1c levels across all 3 groups (P = .74; estimated adjusted mean hemoglobin A 1c difference, SMBG with messaging vs no SMBG, −0.09%; 95% CI, −0.31% to 0.14%; SMBG vs no SMBG, −0.05%; 95% CI, −0.27% to 0.17%). There were also no significant differences found in HRQOL. There were no notable differences in key adverse events including hypoglycemia frequency, health care utilization, or insulin initiation. CONCLUSIONS AND RELEVANCE In patients with non-insulin-treated type 2 diabetes, we observed no clinically or statistically significant differences at 1 year in glycemic control or HRQOL between patients who performed SMBG compared with those who did not perform SMBG. The addition of this type of tailored feedback provided through messaging via a meter did not provide any advantage in glycemic control. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02033499

Background Patients with Systemic Lupus Erythematosus (SLE) often experience pain and other symptoms that negatively impact quality of life. Interventions that enhance the use of behavioral and cognitive coping strategies may lead to improved outcomes among patients with SLE. Pain coping skills training (PCST) programs have been shown to improve outcomes among patients with other rheumatic conditions, but there have been no trials of PCST among patients with SLE. This study was a preliminary assessment of the feasibility and efficacy of painTRAINER, an automated, internet-based PCST program, among patients with SLE. Methods Participants (n = 60) with SLE from one health care system were randomly assigned with equal allocation to painTRAINER or a wait list control group. PainTRAINER involves 8 modules; participants were instructed to complete one module weekly, along with practice activities for each cognitive or behavioral coping skill. Outcome measures were assessed at baseline and 9-week follow-up, including the Pain Catastrophizing Scale, PROMIS Subscales (Pain Interference, Physical Function, Sleep Disturbance, Anxiety, Depression, Fatigue and Participation), and the LupusPRO questionnaire. Mean changes in outcomes from baseline to follow up and Cohen’s d effect sizes were computed. Results Effect sizes for the painTRAINER group (relative to the wait list group) were small, with changes being greatest for the PROMIS Depression score (d = − 0.32). Among those randomized to the painTRAINER group, 50% accessed the program (“painTRAINER users”). Most of those who did not access the program stated that they did not receive instructions via email. Effect sizes for “painTRAINER users” (relative to wait list) were larger than for the whole painTRAINER group: Pain Catastrophizing d = − 0.60, PROMIS Pain Interference d = − 0.3., PROMIS Depression d = − 0.44, LupusPRO Health-Related Quality of Life d = 0.30. Conclusions PainTRAINER users reported meaningful improvements in multiple physical and psychological outcomes, supporting the potential of PCST programs to benefit individuals with SLE. However, strategies are needed to improve engagement with the program and tailor content to comprehensively address key SLE symptoms and challenges. Trial registration NCT03933839, May 1, 2019.

Background: To obtain information on feasibility and acceptability, as well as preliminary data on efficacy, of an Osteoarthritis Physical activity Care Pathway (OA-PCP). Methods: This was a single group pilot study involving 60 participants with symptomatic, physician diagnosed knee or hip OA, recruited from primary care clinics. Participants self-reported completing less than 150 min per week of moderate-to-vigorous physical activity (MVPA) at baseline. The 3-month OA-PCP intervention involved 3 physical activity (PA) coaching calls (focused on goal setting), three check-in emails and linkage with communitybased or online resources to support PA. Efficacy outcomes were collected at baseline and 4-month follow-up. The primary efficacy outcome was minutes of MVPA, assessed via accelerometer. Secondary outcomes included minutes of light intensity activity, sedentary minutes, step counts, and Western Ontario and McMaster Universities (WOMAC) pain and function subscales. Participants were also asked to rate the helpfulness of the OA-PCP intervention on a scale of 0-10. Differences in efficacy outcomes between baseline and 4-month follow-up were assessed using paired t-tests. Results: Among participants beginning the study, 88% completed follow-up assessments and ≥ 90% completed each of the intervention calls. Average daily minutes of MVPA was 8.0 at baseline (standard deviation (SD) = 9.9) and 8.9 at follow-up (SD = 12.1, p = 0.515). There were no statistically significant changes in light intensity activity, sedentary time or step counts. The mean WOMAC pain score improved from 8.1 (SD = 3.6) at baseline to 6.2 (SD = 3.8) at follow-up (p < 0.001); the mean WOMAC function score improved from 26.2 (SD = 13.2) to 20.2 (SD = 12.5; p < 0.001). The mean rating of helpfulness was 7.6 (SD = 2.5). Conclusions: Results supported the feasibility and acceptability of the study, and participants reported clinically relevant improvements in pain and function. PA metrics did not improve substantially. Based on these results and participant feedback, modifications including enhanced self-monitoring are being made to increase the impact of the OA-PCP intervention on PA behavior.

BackgroundThe Pain Coping Skills Training for African Americans with OsteoaRTthritis (STAART) trial is examining the effectiveness of a culturally enhanced pain coping skills training (CST) program for African Americans with osteoarthritis (OA). This disparities-focused trial aimed to reach a population with greater symptom severity and risk factors for poor pain-related outcomes than previous studies. This paper compares characteristics of STAART participants with prior studies of CST or cognitive behavioral therapy (CBT)-informed training in pain coping strategies for OA.MethodsA literature search identified 10 prior trials of pain CST or CBT-informed pain coping training among individuals with OA. We descriptively compared characteristics of STAART participants with other studies, in 3 domains of the National Institutes of Minority Health and Health Disparities’ Research Framework: Sociocultural Environment (e.g., age, education, marital status), Biological Vulnerability and Mechanisms (e.g, pain and function, body mass index), and Health Behaviors and Coping (e.g., pain catastrophizing). Means and standard deviations (SDs) or proportions were calculated for STAART participants and extracted from published manuscripts for comparator studies.ResultsThe mean age of STAART participants, 59 years (SD = 10.3), was lower than 9 of 10 comparator studies; the proportion of individuals with some education beyond high school, 75%, was comparable to comparator studies (61–86%); and the proportion of individuals who are married or living with a partner, 42%, was lower than comparator studies (62–66%). Comparator studies had less than about 1/3 African American participants. Mean scores on the Western Ontario and McMaster Universities Osteoarthritis Index pain and function scales were higher (worse) for STAART participants than for other studies, and mean body mass index of STAART participants, 35.2 kg/m2 (SD = 8.2), was higher than all other studies (30–34 kg/m2). STAART participants’ mean score on the Pain Catastrophizing scale, 19.8 (SD = 12.3), was higher (worse) than other studies reporting this measure (7–17).ConclusionsCompared with prior studies with predominantly white samples, STAART participants have worse pain and function and more risk factors for negative pain-related outcomes across several domains. Given STAART participants’ high mean pain catastrophizing scores, this sample may particularly benefit from the CST intervention approach.Trial registration NCT02560922 Electronic supplementary materialThe online version of this article (10.1186/s12891-018-2249-6) contains supplementary material, which is available to authorized users.

Objective.To measure the association between health literacy and both patient-reported and clinical outcomes in patients with non–insulin-treated type 2 diabetes.Research Design and Methods.We surveyed patients with non–insulin-treated type 2 diabetes (n = 448) from 15 primary care practices. The association between health literacy and patient-reported and clinical outcomes, including numeracy of self-monitoring of blood glucose (SMBG) use, how often physicians advised patients to conduct SMBG testing, and glycemic control (as measured by A1C), was investigated.Results.Study participants included 448 patients with non–insulin-treated type 2 diabetes located within central North Carolina. Participants with limited health literacy had poorer glycemic control (A1C 7.7 ± 1.1% vs. 7.5 ± 1.0%, P = 0.016) despite using SMBG testing more frequently (daily SMBG testing 49.3 vs. 30.7%, P = 0.001) compared to individuals with adequate health literacy. The difference in how often physicians advised patients to conduct SMBG testing between limited and adequate health literacy groups was not significant (P = 0.68).Conclusion.Limited health literacy was associated with poorer glycemic control and an increased frequency of SMBG testing in patients with non–insulin-treated type 2 diabetes. There was no significant difference in how often physicians advised patients to conduct SMBG testing between patients with limited and adequate health literacy.