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. 2021 Apr 14;9(4):463.
doi: 10.3390/healthcare9040463.

Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial

Mar Gomis-Pastor  1 , Sonia Mirabet Perez  2 , Eulalia Roig Minguell  3 , Vicenç Brossa Loidi  3 , Laura Lopez Lopez  3 , Sandra Ros Abarca  3 , Elisabeth Galvez Tugas  3 , Núria Mas-Malagarriga  4 , Mª Antonia Mangues Bafalluy  5
Affiliations

Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial

Mar Gomis-Pastor et al. Healthcare (Basel). .

Abstract

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.

Keywords: behavioral sciences; heart transplantation; immunosuppression; interdisciplinary health team; medication therapy management; mobile health; patient-reported outcome measures; telemedicine; treatment adherence and compliance; treatment outcome.

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Conflict of interest statement

The mHeart® platform technology was developed by a private Spanish firm specializing in healthcare system applications (Trilema Salud S.L.). Most of the authors have collaborated as consultants. The developers had no role in the design, data collection and analysis, decision to publish, or final preparation of the studies or published manuscripts. The Hospital Research Institute owns the legal property of the mHeart national trademark and the intellectual property of the mHeart content. The authors declare no other conflicts of interest.

Figures

Figure 1
Figure 1
The mHeart mobile application main screen captures. The different app modules are displayed: Treatment, Agenda, Self-reliance, Symptoms, Messaging, Health Education and Advice, Personal and Clinical Data. The platform details have been published in the pilot study [34], a summary is also provided in Supplementary File S1.
Figure 2
Figure 2
The mHeart strategy components. The strategy definition and design has been published in the pilot study [34], a summary is also provided in Supplementary File S1.
Figure 3
Figure 3
Study design. Scheduled in-clinic visits are shown as triangles: T0 (baseline at study inclusion), T1 (at least 6 months after inclusion), T2 (at least 12 months after inclusion). The variables assessed during scheduled visits are shown as squares: baseline information, patient experience and medication adherence. Treatments are shown as pictograms, i.e., (i) in-clinic visits at the Hospital outpatient department, (ii) multidisciplinary team including the pharmacist and (iii) the mHeart mobile application for remote interaction with the pharmacist. The diamonds show the scheduled interaction with the clinical pharmacist to perform interventions: blue (during the scheduled in-clinic visits; all patients) and green (using the mHeart tool; intervention group only).
Figure 4
Figure 4
Patient flow chart according to the CONSORT guidelines.
Figure 5
Figure 5
Adherence to immunosuppressive treatment according to the SMAQ interview questionnaire, the Timing of medication taking (IMTS test), the Global BAASIS patient self-reported questionnaire and the Haynes–Sackett adherence to concomitant medication scale. Scheduled in-clinic visits were T0 (baseline at study inclusion) and T2 (at least 12 months after inclusion). Control Group (CG) was based on (i) in-clinic visits at the Hospital outpatient department and (ii) multidisciplinary team including the pharmacist. Intervention Group (IG, the mHeart Strategy) was based on (i) in-clinic visits at the Hospital outpatient department, (ii) multidisciplinary team including the pharmacist and (iii) the mHeart mobile application for remote interaction with the pharmacist.
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