RESUMO
(1) Background: In the mHeart trial, we showed that an eHealth intervention, mHeart, improved heart transplant (HTx) recipients' adherence to immunosuppressive therapy compared with the standard of care. Herein, we present the analysis assessing whether mHeart reduces complication frequency and healthcare resource use, and whether this reduction depends on patients' adherence. (2) Methods: The mHeart was a single-center randomized-controlled trial (IIBSP-MHE-2014-55) in 134 adult HTx recipients (n = 71 intervention; n = 63 controls). The endpoints were mortality, complications, and resource use during follow-up (mean 1.6 ± 0.6 years). (3) Results: A significantly lower proportion of HTx recipients in mHeart had echocardiographic alteration (2.8% vs. 13.8%; p = 0.02), cardiovascular events (0.35% vs. 2.4%; p = 0.006), infections (17.2% vs. 56%; p = 0.03), and uncontrolled Hba1c (40.8% vs. 59.6%; p = 0.03) than controls. In addition, a significantly lower proportion of patients in the intervention needed hospital (32.4% vs. 56.9%; p = 0.004) or urgent admissions (16.9% vs. 41.4%; p = 0.002) and emergency room visits (50.7% vs. 69.0%; p = 0.03). Adherence status (measured by the self-reported SMAQ) influenced only controls regarding hospitalizations and emergency room visits. Differences were not significant on deaths (intervention 4.2% vs. control 9.5%; p = 0.4) (4) Conclusions: the mHeart strategy significantly reduced the occurrence of the studied post-transplant complications and the need for medical attention in HTx recipients. Adherence status influenced controls in their need for medical care.
RESUMO
Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients' experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients' experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.