A Mobile App (mHeart) to Detect Medication Nonadherence in the Heart Transplant Population: Validation Study

Abstract

Background Medication nonadherence in heart transplant recipients (HTxR) is related to graft loss and death. mHeart is a mobile app that uses electronic patient-reported outcome measures (ePROMs) to identify and manage medication nonadherence in the outpatient heart transplant (HTx) population. Objective The study primarily aimed to validate mHeart to measure medication nonadherence in early stage HTxR by assessing the psychometric properties of ePROMs. The secondary aims were to (1) measure patient satisfaction with the mHeart tool and its usability and (2) explore the impact of a theory-based treatment on medication nonadherence rates to determine its scalability to larger research. Methods A prospective study was conducted in the outpatient clinic of a tertiary hospital. All consecutive early stage HTxR (<1.5 years from HTx) were included. The ePROM psychometric properties assessed were validity, reliability, responsiveness, interpretability, and burden. ePROMs comprised the 4-item Morisky-Green-Levine questionnaire and an adapted version of the Haynes-Sackett questionnaire. The Simplified Medication Adherence Questionnaire (SMAQ) was also applied on-site. Three consecutive medication nonadherence assessments were performed by a transplant pharmacist. To improve medication nonadherence, theory-based interventions were delivered in a 1-month period. Patient satisfaction was assessed by a semiquantitative Web-based survey at the end of the study. Results We included 31 early stage HTxR (age: mean 54 years, SD 12 years), and 71% (22/31) of them were men. The HTxR were taking a mean 13 (SD 4; range 7-18) drugs per day. A total of 42% (13/31) of patients were unaware of the consequences of medication nonadherence, and 39% (12/31) of patients were nonadherent to immunosuppressive treatment. The content validity measure showed excellent levels of expert panel agreement for the Haynes-Sacket (14/14, 100%) and Morisky-Green-Levine (13/14, 93%) questionnaires. SMAQ and Morisky-Green-Levine ePROMs showed similar measurement domains (convergent validity, phi=0.6, P<.001), which, as expected, differed from Haynes-Sackett ePROMs (divergent validity, phi=0.3, P=.12). Reliability assessment revealed a very strong association between ePROM and on-site PROMs (phi>0.7, P<.001). Reproducibility was moderate (Haynes-Sackett κ=0.6, P<.002) or poor (Morisky-Green-Levine κ=0.3, P=.11) because of unexpected improved medication adherence rates during the test-retest period. According to responsiveness, the theory-based multifaceted intervention program improved medication nonadherence by 16% to 26% (P<.05). A burden analysis showed that ePROMs could potentially overcome traditional on-site limitations (eg, automatic recording of ePROM responses in the hospital information system). The mean score for overall patient satisfaction with the mHeart approach was 9 (SD 2; score range: 0-10). All 100% (29/29) of patients surveyed reported that they would recommend the mHeart platform to other HTxR. Conclusions ePROMs adhered to the quality standards and successfully identified medication nonadherence in the HTx population, supporting their widespread use. The theory-based intervention program showed a promising improvement in medication adherence rates and produced excellent patient satisfaction and usability scores in HTxR.

Telemedicine in Heart Failure during COVID-19: Like it, Love It or Lose It?

“…Before COVID-19 became prominent, clinicians and investigators were using and examining telemedicine strategies to better meet patients in their communities. For example, telemedicine has been used to detect medication nonadherence 2 and to facilitate selfcare lifestyle modifications and clinical decisions. 3,4 Although innovations in telemedicine have been ongoing, use was primarily an adjunct to office visits until the Centers for Medicare & Medicaid Services broadened access to telehealth services for Medicare beneficiaries on an emergency and temporary basis, as part of the COVID-19 Preparedness and Response Supplemental Appropriations Act.…”

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

“…The main features of the platform are designed to (i) identify MNA recipients, (ii) resolve patients’ doubts about their treatment and health status, (iii) empower patients in terms of self-care and (iv) facilitate professionals’ interventions based on online patient-reported outcomes. The description, development and quality assurance of the software (mHeart Version 3) have been published in a pilot study [ 34 ]. Details about its clinical use and functionalities are provided in Supplementary File S1 and Mendeley Dataset [ 32 ].…”

“…The study was approved by the Institutional Review Board of the hospital (IIBSP-MHE-2014-55) and was registered in (ID MHEART: NCT02554578). A pilot study to validate the feasibility of the intervention included patients who were <1.5 years post-transplant [ 34 ]. The present study included adult HTx recipients who were >1.5 years post-transplant.…”

“…Additionally, for patients randomized to the mHeart strategy (IG), multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart tool. The mHeart intervention procedures and algorithm have been validated previously in the pilot study [ 34 ] and has been detailed in Supplementary File S1 .…”

“…( Figure 1 ) It was designed by the multidisciplinary HTx team to support an intensive, individualized, behavior-based strategy to improve the safety and efficacy of medication taking and to facilitate comprehensive care in HTx recipients ( Figure 2 ). A previous pilot study validated the feasibility of this intervention and satisfaction of patients with the mHeart tool [ 34 ].…”