Abstract
Introduction: Non-adherence is a main issue after heart transplantation. The main objective of this study is to evaluate if a mHealth-based strategy is better than the conventional approach to improve adherence in adults heart transplanted recipients and to asses patients experience of therapeutic regimens. Methods: This is a single-center randomized controlled trial (RCT). Adult HTx recipients who were >1.5 years post-transplant were randomly assigned 1:1 to the control group or intervention group. Control group patients received usual care and the intervention group received a mHealth based care strategy using the mHeart software (mobile application).Results: A total of 134 HTx recipients were randomized [intervention N=71; control N=63]. An attrition rate of 4% was observed. The mean follow-up was 1.6 (SD 0.6) years. Mean age was 55 (SD14) years; 30% were women. Adherence rate improvement from the baseline was >65% according to the SMAQ questionnaire, significantly higher in the intervention group (85 % vs 46% 65% OR=6.7 (2.9;15.8), P-value=.000]. Patients’ experience of therapeutic regimens (including the degree of inconvenience related to taking medication [P-value=.002], patient’s knowledge of their regimen intakes [P-value=.019], drugs names [P-value=.006], drugs doses [P-value=.030] and drugs indications remembered [P-value=.003]) significantly improved in the intervention versus the control group. In addition, patient’s awareness of the consequences of nonadherence significantly improved in both groups [P-value<.01]. The in-clinic appointment needs and the intensity of the follow-up were significantly reduced in the intervention group (65%) versus the control group (35%) [OR=3.4 (1.7;6.9), P-value=.001]. Conclusions: In our study, a mHealth based strategy significantly improved adherence in heart transplant recipients. A significantly reduction on the number of patients needing to travel to the clinic for follow-up appointments with the clinical pharmacist was documented. The mHealth approach will be a feasible way to continue providing long-term advanced individually-tailored interventions by health providers to HTx recipients in the at-home setting.
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