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

Abstract: Background 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.

 Conditions of use, a mixture of time-based, event-based or task-completion rules were applied as required. [22] Thus, the complexity of the strategies varied depending on the patient and the task. A combination of these techniques was common.  Video calls were not scheduled and were limited to very occasional situations when a text message was insufficient to deliver highly complex information. (1),(2) Adh. & Nonadh.
(1),(2),(4 b Elements (i.e. components or objects of the technology intended to implement the strategy) used in the study: (A) alerts, (P) prompts/reminders, (N) notifications, (M) messages, (L) logs, (R) reports, (V) visualizations, (C) video-calls, (I) Information delivery. [5,6] c Nonadherence to medication in the implementation phase is defined as "actual dosing does not correspond to the prescribed dosing regimen due to delays, omissions or extra doses" and is measured by self-report questionnaires. Delays refer to irregularities with the intake schedule (±2 hours).
d Definitions: Baseline: when the treatment begins; Continuously: every time the task is scheduled during the treatment period between assessment 1 and 2; If needed: when provider detect that the strategy is needed based on reports or goals established; Once/ week: at least 1 time per week based on reports; W1: during week 1 of the study; W2: during week 2 of the study; W3: during week 3 of the study.

C) The MHeart® features. Patient and professional profiles: modules, components, and clinical use.
Details including videos about how the application works, how the patient interacts with it and a fully

Agenda
The content of diverse modules is uploaded. A Push text alert can be activated on the patient's mobile phone.
1. Medication timing and consultation of recommendations. 2. Drug intake recording (single or several drugs at the same time) and reasons for nonadherence (drop-down list). 3. Non-pharmacological prescriptions (e.g. relaxation practice according to the psychologist's prescription). 4. Tasks from the Patient-Centered Module programmed (e.g. blood pressure monitoring 3 times per week). 5. Health reminders (e.g., appointments, blood tests).

Communication Aids
1. Teleconference: individual and group sessions. 2. A private patient-provider chat. Files can be attached.

Health Advice
Healthy lifestyle and health promotion information (e.g., texts, photographs, or multimedia files).

Personal and Clinical Data
Sociodemographic data, documented allergies and provider profiles (including affiliation and picture).
Help 1. A help center service to solve both technical and functional problems (i.e. telephone number, private message, and email). 2. Clinical contact data: medical team, pharmacist, transplant coordinator, patient appointment center, etc.

About
Information about the developers, the aim of the tool, and the team in charge of it.

Terms of Use and Privacy Policy
All the legal requirements already accepted should always be available for consultation.

Patient View
List of active patient filters to organize the list and perform a rapid search.

Patient Registration
1. The Center identification number is used to download patient data from the hospital information system. 2. The patient receives a private message with login credentials. 3. Providers individualizes the patient-reported outcome measures schedule and the treatment plan and recommendations for each new patient.

Treatment Prescription
1. Pharmacological treatment is prescribed from a drop-down list of drugs updated from the Spanish National Formulary. Tailored recommendations can be added (e.g. "Anti-rejection treatment. It is recommended that you take this on an empty stomach"). 2. Non-pharmacological therapies can be prescribed in free-form data entry by the multidisciplinary team (e.g. non-salty diet).

Patient-Centered Data Consultation
All the data recorded in the Patient-Centered Module can be tracked graphically in tables and diagrams. Timeframes filters can be used. mHeart® platform features designed to follow medication adherence are adherence test results and drug intake registrations: 1. A traffic light system alerts provider of a decrease in the patient's weekly adherence. List of patients can be sort by adherence rate to prioritize interventions.
2. Adherence rates are presented graphically and through tables (for each drug and for the overall treatment).  Abbreviations: HTx, heart transplantation; M, mean; RCT, Randomized controlled trial; SD, standard deviation.