Effectiveness of a Theory-Driven mHealth Intervention on Patients’ Post-Surgery Rehabilitation Adherence: A Randomized Clinical Trial (Preprint)
BACKGROUND Low adherence to post-surgery rehabilitation programs among anterior cruciate ligament (ACL) reconstruction patients is frequently reported. It is important to develop effective interventions that promote adherence to treatment and rehabilitation in ACL ruptured patients. OBJECTIVE This study aimed to assess effects of a theory-based smartphone-delivered intervention on ACL ruptured patients’ psychological, behavioral, and clinical outcomes during post-surgery rehabilitation period. METHODS We recruited 96 eligible participants (Mage = 27.824, SD = 8.732, range = 18 to 53; female = 38.947%) who underwent ACL reconstruction surgery. Participants were randomly assigned to a treatment group (n=41), which received standard post-surgical treatment and smartphone application (“ACL-Well”) delivering the intervention, or a control group (n=55), which received standard post-surgical treatment only. The primary outcomes were the recovery outcomes from ACL surgery, measured by knee muscle strength and laxity, and subjective knee evaluation completed 4-month post-intervention. Secondary outcomes were the psychological and behavioral outcomes measured at baseline within 2 weeks of surgery, and at 2- and 4-month post-intervention follow-up. RESULTS ANCOVA suggested no significant difference between the intervention and the control group in the recovery outcomes. Growth mixture modelling revealed self-determined treatment motivation declined significantly over the intervention period in the control group, but not in the intervention group. Intention and rehabilitation adherence also revealed similar patterns among patients who had lower levels of motivational or behavioral factors of rehabilitation at baseline. CONCLUSIONS The smartphone application developed in this project shows promise as a means to promote orthopedic outpatients’ motivation and adherence to treatment, but fell short in promoting recovery. Research on long-term effects of interventions are needed. CLINICALTRIAL HKUCTR-2761