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Objective Test the efficacy of educational interventions to reduce literacy barriers and enhance health outcomes among patients with inflammatory arthritis. Methods The intervention consisted of plain language information materials and/or two individualized sessions with an arthritis educator. Randomization was stratified by education level. Principal outcomes included adherence to treatments, self-efficacy, satisfaction with care, and appointment keeping. Secondary outcomes included health status and mental health. Data were collected at baseline, six, and twelve months post. Results Of the 127 patients, half had education beyond high school and three quarters had disease duration greater than five years. There were no differences in the primary outcome measures between the groups. In mixed models controlling for baseline score and demographic factors, the intervention group showed improvement in mental health score at six and twelve months (3.0 and 3.7 points, respectively), while the control group showed diminished scores (−4.5 and −2.6 points, respectively) (p=0.03 and 0.01). Conclusion While the intervention appears to have had no effect on primary outcomes, further studies with continued attention to literacy are warranted. Study site and disease duration must be considered as participants in this study had higher than average health literacy and had established diagnoses for years prior to this study. Practice Implications The study offers insight into an application of many of the protocols currently recommended to ameliorate effects of limited literacy.

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Objective. A feasibility study for a trial of strategies for the prevention of atherosclerosis in patients with systemic lupus erythematosus (SLE) was stopped because of inadequate recruitment. There is little understanding of the factors influencing patients' decisions about participation in prevention trials. Our goal was to determine factors that patients with SLE consider in deciding about participating in prevention trials, to uncover concerns about SLE trials, and to investigate how study design and purpose affect participation decisions. Methods. We conducted focus groups with trial participants (n ‫؍‬ 13), trial nonparticipants (n ‫؍‬ 8), and a group of patients with diabetes (n ‫؍‬ 9). We conducted telephone interviews with SLE patients who refused participation in the trial and the focus groups (n ‫؍‬ 10). A trained facilitator elicited factors influencing participation decisions. Transcripts were coded and grouped into themes using grounded theory. Results. Demographic characteristics of the groups were similar. Seven factors emerged as important in decision making: current health status, study design, physician involvement, personal benefit, altruism, time, and incentives. These factors were considered by individuals who elected to participate and those who did not, but weighed differently. Among the trial participants, good health status, encouragement from one's physician, and desires to learn and to contribute stimulated participation. Reasons for nonparticipation included current health status, medication and randomization concerns, and personal factors. Conclusion. We observed that similar factors were weighed differently by participants and nonparticipants. Our results suggest that strategies such as health education, enlistment of personal physicians, and limitation of time requirements may enhance recruitment of patients with SLE into clinical prevention trials.