Excellent multi-stakeholder acceptability and reimbursable costs in a pilot pragmatic trial of an evidence-based physical activity counseling intervention for patients with type 2 diabetes

Abstract

Background: Physical activity (PA) improves important health outcomes for patients with type 2 diabetes mellitus (T2D), including physical function. We iteratively adapted the implementation strategies of pragmatic and evidence-based PA counseling programs to meet primary care stakeholders’ needs, resulting in the “Be ACTIVE” program. In a pilot randomized pragmatic trial, we evaluated the feasibility, acceptability and effectiveness of Be ACTIVE. Methods: Formative activities involved engaging multi-level stakeholders (patients, clinicians, coaches) to tailor implementation strategies for Be ACTIVE to the primary care context, while taking care to preserve the core “functions” of Be ACTIVE. Be ACTIVE included: a PA tracker (FitBit©), six theory-informed PA counseling phone calls, and three in-person clinician visits. Sedentary patients with T2D from two academic primary care clinics were randomized to Be ACTIVE vs. enhanced usual care. We used mixed methods to assess implementation outcomes of feasibility and acceptability among multi-level stakeholders, including costs. Objective effectiveness outcomes included PA (primary outcome, steps/week), physical function (secondary outcomes, including Short Physical Performance Battery (SPPB)), and behavioral PA predictors. Results: Multi-level stakeholders were engaged in formative activities to design a feasible pragmatic intervention. Fifty patients were randomized to Be ACTIVE or enhanced usual care. Acceptability was >90% for patients and clinic staff. In-person visits were fully reimbursed, and counseling costs of ~$90/patient would be reimbursable by Medicare. Pre-post PA increased by ~11% absolute in the Be ACTIVE group and by ~6% in controls (group difference: 1574 ± 4391 steps/week, p = 0.72) — less than the clinically important threshold of 4200 steps/week. Be ACTIVE participants’ physical function improved more than controls (SPPB: +0.9 ± 0.3 versus -0.1 ± 0.3, p = 0.01, changes >0.5 points are clinically important for preventing falls), and for PA predictors of self-efficacy (p=0.02) and social-environmental support (p<0.01). Conclusions: In this pilot trial, Be ACTIVE was feasible and highly acceptable to stakeholders and yielded significant improvements in objective physical function consistent with lower fall risk, while changes in PA were less than anticipated. Be ACTIVE may need adaptation or longer duration to clinically improve PA outcomes. Further optimizing the implementation strategies for sustainability is also needed.