TABLE 1.

mHealth clinical outcomes studies

Authors	Study design	Population	Intervention	Outcomes
Education and Adherence
McGillicuddy  et al21	Prospective, randomized pilot study	Kidney transplant recipients identified as nonadherent based on screening using electronic medication tray	Electronic medication tray with reminders, Bluetooth BP monitor, smartphone for transmitting data and send reminders to check BP (SMASK System)	Nineteen subjects enrolled. Medication adherence improved progressively. SBP decreased from 138 to 122 mm Hg in mHealth vs 135 to 138 mm Hg (P < 0.05 at month 3). High overall satisfaction with mHealth system (4.8/5 Likert scale)
DeVito Dabbs  et al22	Prospective randomized trial	Adult lung transplant recipients immediately after transplant	Self-monitoring days, adherence to medical regimen, reporting of critical health indicators, admissions, hospitalization days, death	Two hundred one patients enrolled between intervention (n = 99) and usual care (n = 102). mHealth group performed more self-monitoring than controls (OR, 5.11; 95% CI, 2.95-8.87; P < 0.001) and were more likely to be adherent to the regimen at 12 mo of follow-up (OR, 1.64; 95% CI, 1.01-2.66; P = 0.046). mHealth group reported more critical values (OR, 3.1; 95% CI, 1.37-7.01; P = 0.007). No differences in readmissions, hospitalization days, or death
Reese et al23	Single-center, randomized controlled trial	Kidney transplant recipients	Two intervention groups: customized reminders (alarms, texts, telephone calls and emails); customized reminders plus provider notification (every 2 wk, providers were notified if adherence was <90%) in addition to the usual care group	One hundred twenty subjects enrolled. Adherence (measured using wireless pill bottles) was significantly better for both intervention groups compared with controls (78% [reminders], 88% [reminders plus notification], 55% [control], P < 0.001 in comparison of each group with control); no difference in mean or median tacrolimus levels, CV of tacrolimus levels, or percentage of tacrolimus measurements in the target range
Jiang et al24	Cross-sectional correlational study	Adult lung transplant recipients currently using Pocket PATH for daily self-monitoring	Pocket PATH generated a feedback message any time a critical value was entered detailing the information that should be reported to their coordinator	Of 96 subjects, 53 had at least 1 critical message generated. Most (90%) responded to the message, whereas 62% followed decision support. Moderate users of Pocket PATH (vs high and low utilizers), patients with lower income, and those with longer hospital stays were less likely to follow decision support
Geramita  et al25	Long-term follow-up of a randomized controlled trial	Post–lung transplant recipients	Pocket PATH app, including reminders for medication taking and appointments, patient-entered results for health indicators established by transplant programs	One hundred five LTRs (75% of survivors) were assessed (M = 3.9 y posttransplant, SD = 0.8). Nonadherence rates in the past month were 23%–81% for self-care and lifestyle requirements (diet, exercise, BP monitoring, spirometry), 13%–23% for immunosuppressants and other medications, and 4% for tobacco use, with 31% clinic appointment nonadherence in the past year. In multivariable analysis, the Pocket PATH group showed lower risk of nonadherence to lifestyle requirements (diet/exercise) than the usual care group (P < 0.05)
Korus et al26	Randomized controlled trial	Twelve- to 17-y-old kidney or liver transplant recipients	Comprehensive online educational program, including interactive animations, on waitlist and posttransplant topics determined by a multidisciplinary team	Forty-two patients enrolled. Patients enjoyed learning about other teen experiences but reported barriers to accessing the site because of being too busy, computer being too slow, and inability to access it on their mobile device. Time spent on the site was low. No differences in health-related outcomes between groups
Torabi et al27	Single-center, prospective, randomized trial	Kidney transplant recipients	Use of Transplant Hero, a commercial app	Patients were randomized into app users (n = 18) and nonusers (n = 49). Tacrolimus CV was significantly lower in app users vs nonusers at 1 mo (27.7 vs 37.0, P = 0.014) but not at 3 mo (33.6 vs 35.4, P = 0.63)
Zanetti-Yabur  et al28	Single-center, prospective, self-selected trial	Kidney or liver transplant recipients	Use of Transplant Hero, a commercial app	Patients self-selected into app users (n = 21) vs nonusers (n = 53). No significant difference in BMQ scores, MMAS-8, or IAT survey. No difference between mean serum tacrolimus levels or serum creatinine
Foster et al29	Multicenter parallel-arm randomized trial	Kidney transplant recipients aged 11–4 y and ≥3 mo posttransplant	TAKE-IT intervention: patient choice of text message, email, visual cue dose reminders in addition to meeting with coach at 3-mo intervals; adherence monitored with electronic pillbox	Three hundred eighty-eight patients screened, 277 eligible, and 172 enrolled: 81 subjects were enrolled in the intervention, whereas 88 were enrolled in the control group. Participants in the intervention group had significantly greater odds of taking their prescribed medications (OR, 1.66; 95% CI, 1.15-2.39) and taking their medications at or near the prescribed time (OR, 1.74; 95% CI, 1.21-2.50)
Han et al30	Single-center prospective, randomized, controlled trial	Kidney transplant recipients	Adhere4U app (audible and visual reminders, personal tracking of administration times, medication adherence report, detailed medication information, educational video, and patient laboratory test results) with electronic adherence monitoring	One hundred thirty-eight transplants randomized to mobile intervention (n = 71) or control (n = 67). No difference in change in nonadherence over time, assessed by BAASIS and VAS. Low patient engagement with high attrition (app use 47.6% at 28 d, 33.9% at 90 d, 11.5% at 180 d)
Tsapepas  et al31	Single-center, retrospective description	Kidney transplant recipients early posttransplant	MRxEd app: medication collection and selection, video streaming with local clinician education modules, dynamic questioning, real-time notifications, and robust data reporting	Two hundred eighty-two patients described; 90% able to correctly answer questions about drug indications; however, 61% had trouble tying adverse events to specific medication; 92% of patients rated the education process as 4 or 5 on a Likert scale
Levine et al32	Single-center, prospective cohort	Kidney, SPK, CLKTx	Transplant Hero, medication reminders, and educational content, with or without a Pebble Smart Watch	One hundred eight patients enrolled, 19% with app and smartwatch, 35% app alone, 46% with no intervention. No significant differences between groups for tacrolimus CV at 1 or 3 mo
Gomis-Pastor  et al33	Single-center, prospective cohort	Heart transplants within 1.5 y of transplant	mHeart: bidirectional interface that uses ePROM to detect medication nonadherence, report to healthcare professionals, and use text reminders to take medications, with self-reported dose administration tracking	Thirty-one patients enrolled, 42% were unaware of nonadherence consequences, and 39% were self-reportedly nonadherent; according to self-reported responses, intervention improved nonadherence by 16%–26% (P < 0.05)
McGillicuddy  et al34	Post hoc analysis of 6-mo prospective, parallel-arm, randomized controlled clinical trial	Kidney transplant recipients identified as nonadherent based on screening using electronic medication tray	Electronic medication tray with reminders, Bluetooth BP monitor, smartphone for transmitting data and send reminders to check BP (SMASK System)	Baseline tacrolimus CV was similar between arms (37% vs 37%, P = 0.894). Patients randomized to the intervention had significant reduction in mean 12-mo tacrolimus CVs (P = 0.046) and a significant improvement in the proportion achieving low tacrolimus CV <40% (P = 0.001)
Fleming et al35	Secondary planned analysis of 12-mo, parallel, 2-arm, semi-blind, 1:1 randomized controlled trial	One hundred thirty-six participants randomized to mHealth-based, pharmacist-led intervention vs usual posttransplant care	TRANSAFE Rx app: mobile app with real-time medication lists from transplant center EMR, medication reminders and patient-reported tracking, Bluetooth-enabled BP and BG monitors, adverse event tracking, tacrolimus CV tracking, and clinic visit adherence tracking	The intervention arm demonstrated statistically significant decrease in tacrolimus IPV over time compared with control arm (P = 0.0133). Significantly more patients in intervention group met goal of IPV <30% at 12 mo (P = 0.033), despite groups being comparable at baseline
Control of chronic conditions
Aberger et al36	Retrospective cohort	Kidney transplant recipients referred to a pharmacist for BP management (within 1 y of transplant or >3 y from transplant)	Home-based monitoring of BP with automated feedback messages to reinforce or prompt home BP monitoring. BP managed by a pharmacist	The 66 patients enrolled had a significant decrease in systolic (6 mm Hg) and diastolic (3 mm Hg) blood pressures (P < 0.01) from baseline
McGillicuddy  et al37	Retrospective review of long-term results after prospective, randomized pilot study	Kidney transplant recipients studied for 3 mo using mHealth system (9) and BP control 9 mo after trial ended	mHealth from month 0 to 3 listed in previous study and usual care from month 3 to 12	Of 18 subjects assessed, prior mHealth group sustained lower BP at 12 mo compared with the usual care group (131 vs 155 mm Hg, P = 0.004)
Rosenberger  et al38	Long-term follow-up of a prospective, randomized trial	Adult lung transplant recipients from previous study who survived to 12 mo posttransplant	Pocket PATH app: records daily health indicators, provides graphical displays of trends, advises patients to notify coordinator if health indicators outside of preestablished parameters	Eighty-eight intervention patients were compared with 94 usual care patients. No effect on outcomes. Self-monitoring (regardless of study group) reduced mortality risk (HR, 0.45; 95% CI, 0.22-0.91; P = 0.027). Reporting of critical health indicators was associated with reduced mortality risk (HR, 0.15; 95% CI, 0.04-0.65; P = 0.011) and BOS (HR, 0.27; 95% CI, 0.08-0.86; P = 0.026)
Singer et al39	Single-center, prospective before-and-after study	Lung transplant recipients	In-person assessment and training followed by home-based exercise phase using a mobile education and tracking app with real-time provider monitoring and interface (Aidcube), and weekly coordinator check-ins	Fifteen participants enrolled out of 45 screened; 13 completed follow-up; 89% of subjects had a lack of access to traditional pulmonary rehabilitation. Participants had moderate adherence (60%) with high perceived utility ratings. SPPB frailty scores improved in 7 (54%) and FFP frailty scores improved in 8 (62%). No at-home safety events
Moayedi et al40	Single-center, prospective pilot study	Heart transplant recipients, postdischarge for the first 30 d of follow-up	Remote monitoring of health status using 5 wirelesses within digital devices, including smart watch, scale, BP cuff, thermometer, sleep tracker	Five consecutive male transplant patients were enrolled. Two patients were readmitted within 30 d of transplant discharge. Biometric data were available 70%–80% of the time for step count, heart rate, and BP during the 4-wk study period. Temperature was available between 60% and 80% of follow-up days. Weight measurements decreased significantly over time, from 75% of days in week 1 to 10% of days in week 4. Time in tacrolimus therapeutic range was 30%; no patients had rejection. Descriptive results of improved workflow efficiency, favorable use feelings toward educational videos, but frustration that there was no 2-way communication to personalize the experience, in addition to a feeling of notification burnout
Schenkel  et al41	Single-center, prospective, observational pilot study	Lung transplant recipients after discharge, followed up for 2 y and compared with matched controls	Bluetooth-enabled devices including BP, heart rate, weight, BG, oxygen saturation, pulmonary function, and activity levels; incentive badges and humorous memes for high compliance, encouraging messages for poor compliance	Patients enrolled in program experienced lower incidence of readmission (IRR, 0.56; 95% CI, 0.41-0.76; P < 0.001), which remained significant in multivariate analysis (IRR, 0.38; 95% CI, 0.23-0.63; P < 0.001), along with Black race. There were also significantly decreased readmission days and hospital readmission charges
Medication errors
Jandovitz  et al42	Single-center, retrospective description	Post–kidney transplant recipients with access to technology with webcam capabilities	Virtual visit with outpatient transplant pharmacist via American Well HIPAA-compliant video interface platform	Half (52%) of the 46 patients who registered for a virtual visit completed 1. An average of 1.2 ± 0.4 medication changes were updated in the medical records
Taber et al43	Single-center, prospective, interventional trial	Kidney transplant recipients at least 1 y posttransplant with stable allograft function	Bluetooth-enabled Home-based monitoring for BP and BG with app and web-based portal. Monthly face-to-face encounters with pharmacists focusing on reducing barriers for CVD risk factor control, medication nonadherence, medication errors, self-efficacy, and lifestyle choices	Sixty patients enrolled, 51 completed follow-up. Improved BP control (50 vs 68%, P = 0.054), HgA1c control (33 vs 47%, P = 0.061). Medication errors reduced from 3.0 ± 2.7 to 0.14 ± 0.44 (–0.71 errors per month, P < 0.001). Patient-reported adherence improved from 59.6% to 89.5% (increased odds of reporting high medication adherence per month: OR, 1.34; 95% CI, 1.10-1.64; P = 0.004)
Gonzales  et al44	Single-center, prospective, randomized controlled interventional trial	Adult kidney transplants between 6 and 36 mo posttransplant	Bluetooth-enabled home-based monitoring for BP and BG, patient-reported adherence and side effects, risk-guided televisits	One hundred thirty-six patients enrolled, 68 in each arm. Participants in the intervention arm experienced a significant reduction in medication errors (61% reduction; incident risk ratio, 0.39; 95% CI, 0.28-0.55; P < 0.001) and a significantly lower incidence risk of grade 3 or higher adverse events (IRR, 0.55; 95% CI, 0.30-0.99; P = 0.05). For the secondary outcome of hospitalizations, the intervention arm demonstrated significantly lower rates vs the control arm (IRR, 0.46, 95% CI, 0.27-0.77; P = 0.005)

app, application; BAASIS, Basel Assessment of Adherence to Immunosuppressive Medication Scale; BG, blood glucose, BMQ, Brief Medication Questionnaire; BOS, bronchiolitis obliterans syndrome; BP, blood pressure; CI, confidence interval; CLKTx, combined liver kidney transplant; CV, coefficient of variability; CVD, cardiovascular disease; EMR, Electronic Medical Record; ePROM, electronic patient-reported measures; FFP, Fried Frailty Phenotype; HIPAA, Health Information Portability and Accountability Act; HR, hazard ratio; IAT, Implicit Association Test; IPV, intrapatient variability; IRR, incident risk ratio; LTR, lung transplant recipients; M, mean; mHealth, mobile health; MMAS-8, Moriskey Medication Adherence Scale - 8 Question; OR, odds ratio; SBP, systolic blood pressure; SD, standard of deviation; SMASK, Smartphone Medication Adherence Saves Kidneys; SPK, simultaneous pancreas kidney transplant; SPPB, Short Physical Performance Battery; TAKE-IT, Teen Adherence in Kidney transplant Effectiveness of Intervention Trial; VAS, Visual Analog Scale.