A Prospective 12-week Randomized Controlled Trial of Remotely-Delivered Customized Adherence Enhancement for Poorly Adherent Individuals with Schizophrenia vs Enhanced Treatment as Usual.

Objective: This prospective 12-week randomized controlled trial tested an adherence promotion approach called Customized Adherence Enhancement in schizophrenia (CAE-S) vs. Enhanced Treatment as Usual (eTAU) in 36 poorly adherent individuals. Methods: Patients were randomized to either CAE-S or eTAU at baseline and were assessed at 12-week follow-up. Primary outcomes were program attendance, patient satisfaction and change in schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale (PANSS). Additional evaluations were adherence measured by the Tablets Routine Questionnaire (TRQ), Clinical Global Impression (CGI), Short Form Health Survey (SF-12), Global Assessment of Functioning (GAF), and Strauss-Carpenter Level of Functioning Scale (SCLFS). Results: Mean age was 44.9 (Standard deviation/SD 12) years. 12-week attrition was 19.4%. At screening, mean past 7-day TRQ (proportion of days with missed dose) was 29.7% (SD 23.8) for CAE and 41.7% (SD 26.5) for eTAU. By baseline, mean TRQ improved to 11.3% (SD 15.8) in CAE-S, and to 19.3% (SD 25.7) in eTAU. Mean session attendance (out of a maximum of 6) was 4.89 (SD 1.9) for CAE and 3.88 (SD 2.5) for ETAU. CAE and ETAU satisfaction were both high. From baseline to 12 weeks, mean PANSS improved significantly in both CAE-S (p < .05) and eTAU (p < .01) with no difference between arms. There was no significant change in TRQ, while CGI and GAF improved significantly in both arms with no significant difference between arms. Mean SCLFS improved in both arms, with results favoring CAE (p < .001). Conclusion: Telehealth CAE-S is feasible and acceptable among poorly adherent patients with schizophrenia. Adherence improved rapidly with monitoring, which could explain improvement in schizophrenia symptoms and largely similar outcomes across intervention arms.