A pilot randomized clinical trial of gamification to increase medication adherence

• In a pilot randomized controlled trial, a gamification intervention did not improve adherence to statins and antihypertensive medications compared with control • Most patients contacted declined participation, and the trial did not complete enrollment • Using gamification to promote medication adherence is challenged by high participant burden Medication nonadherence is a key contributor to poor control of cardiovascular risk factors, but most interventions shown to increase adherence are labor-intensive and have not been implemented widely. Gamification interventions informed by behavioral economic theory increase physical activity with minimal cost and personnel requirements. We tested the feasibility of a gamification intervention to increase medication adherence among patients at risk of cardiovascular disease with a history of medication nonadherence. Patients seen in a single primary care clinic who were prescribed 1 or 2 antihypertensive medications and a statin and had a recent history of nonadherence were identified and offered enrollment in a pilot randomized controlled trial. Patients were enrolled on the Penn Way to Health platform, provided with a validated home blood pressure cuff, and randomized to attention control or gamification. Attention control patients received daily text messages asking if they took their antihypertensive medication and statin, and biweekly text messages asking them to check and report their blood pressure. Gamification participants received the same text messages, and were also enrolled in a game in which they were provided with 90 points per week and lost 10 points each day they did not report taking their antihypertensive medications or statin and each time they did not report a blood pressure when requested. Each week, participants with 70 points or more moved up a level; those with less than 70 points moved down a level. The intervention continued for 14 weeks, followed by a 4-week post-intervention follow-up period. The trial’s primary outcome was self-reported adherence. A total of 622 patients were eligible for the study and were contacted by study staff; ultimately 43 (of a planned 84) were enrolled and randomized to gamification (n = 21) or control (n = 22). Mean (SD) age was 65 (7.2), 20 (46.5%) were women, and 25 (58.1%) were Black. Over the 18-week study period, there was no significant difference between arms in adherence to antihypertensive medications (79.6% gamification vs. 78.6% control; difference between arms, 1.4%, 95% CI -1.2 to 3.9%) or statins (80.4% gamification vs. 78.6% control; difference between arms, 1.8%, 95% CI -2.2 to 5.9%). There were no differences in self-reported adherence between arms over the post-intervention follow-up period, and similarly no differences between arms in medication adherence by SureScripts data, systolic blood pressure, or low-density lipoprotein cholesterol. In this pilot randomized controlled trial, we found that a behaviorally-designed gamification intervention did not increase adherence to antihypertensive medications and statins compared with attention control. Challenges with recruiting patients with a history of poor adherence and lack of tools for automated, inexpensive, unobtrusive measurement of daily medication-taking behavior are key limitations to the deployment of gamification to increase medication adherence. clinicaltrials.gov; unique identifier: NCT05326386