Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials.

BACKGROUND

This retrospective, cross-sectional study describes using community mailings followed by ankle brachial index (ABI) testing to identify participants for clinical trials of interventions to improve walking performance in people with peripheral artery disease (PAD). Clinical characteristics of clinical trial participants were compared between PAD participants identified with community-based recruitment vs PAD participants recruited from the medical center.

METHODS

Between January 09, 2012, and October 31, 2025, approximately 10,000 to 60,000 postcards/month were mailed to residents aged 50 and older in Chicago or New Orleans, to recruit PAD participants for clinical trials testing therapies for walking impairment. Respondents with PAD risk factors and walking difficulty were invited to undergo ABI testing. Additional participants were identified from patients with PAD in medical centers in Chicago and New Orleans. The 6-minute walk and questionnaires were administered.

RESULTS

Of 2,856 people (49.9% women, 55.8% Black) who responded to a postcard and underwent ABI testing, 669 (23.4%) had ABI < 0.90, consistent with PAD. Compared to 275 PAD patients from a medical center, PAD participants from the community included a higher proportion of people who were Black (65.5% vs 48.7%, P < .001), with household income < $50,000 (36.7% vs 28.5%, P = .015), and without a college degree (67.6% vs 58.1%, P = .016). Compared to PAD participants identified from a medical center, those identified from the community had poorer 6-minute walk distance (308 vs 334 m, P = .002).

CONCLUSIONS

Approximately 23% of people living in the community who underwent ABI testing as part of a clinical trial recruitment method had PAD. Compared to PAD participants from the medical center, those identified from the community included more people traditionally underrepresented in clinical trials and had greater walking impairment TRIAL REGISTRATION: ClinicalTrials.gov identifier: (NCT03743636, NCT04794530, NCT05624125, NCT02593110, NCT03054519, NCT06032065, NCT06165016, NCT03363165, NCT03871075, NCT06399900, NCT02538900, NCT01408901, NCT04228978, NCT06657976).