A prospective community engagement initiative to improve clinical research participation in patients with peripheral artery disease.

OBJECTIVE: Patients diagnosed with peripheral artery disease are difficult to recruit into clinical trials. However, there is currently no high-quality, patient-centered information explaining why peripheral artery disease patients choose to participate or not participate in clinical research studies. METHODS: The current study was a prospective community engagement initiative that specifically asked patients with and without peripheral artery disease: (1) what motivates them to participate in clinical research studies, (2) their willingness to participate in different research procedures, (3) the barriers to participation, (4) preferences about study design, and (5) demographic and disease-related factors influencing participation. Data were gathered through focus groups (n = 19, participants aged 55-79 years) and mailed questionnaires (n = 438, respondents aged 18-85 years). RESULTS: More than half of the respondents stated that they would be willing to participate in a study during evening or weekend time slots. Peripheral artery disease patients (n = 45) were more willing than those without peripheral artery disease (n = 360) to participate in drug infusion studies (48% versus 18%, p < 0.001) and trials of investigational drugs (44% versus 21%, p < 0.001). Motivating factors and barriers to participation were largely consistent with previous studies. CONCLUSION: Adults in our geographic region are interested in participating in clinical research studies related to their health; they would like their doctor to tell them what studies they qualify for and they prefer to receive a one-page advertisement that has color pictures of the research procedures. Peripheral artery disease patients are more willing than those without peripheral artery disease to participate in drug infusion studies, trials of investigational drugs, microneurography, and spinal/epidural infusions.