Electronic Pill Research Articles

Feasibility and Acceptability of a Mobile Application to Monitor Opioid Use and Promote Behavior Modification Following Cesarean Section

Opioid misuse and associated negative sequelae, including opioid use disorder and overdose, continue to comprise a public health crisis of epidemic proportions. One opportunity for upstream primary prevention of opioid misuse is the management of opioid use during the postoperative period, including following cesarean section. Research shows that most patients who have a cesarean delivery receive a prescription for opioids on discharge, though limited data exist on postoperative opioid use and misuse. Continuous Precision Medicine (CPM) has developed a mobile application that allows patients to track their pain and usage of both opiates and non-steroidal anti-inflammatory (NSAID) medications and includes elements intended to promote behavior modification through psychoeducation and gamification. The aims of this study were to determine logistical and technological feasibility and acceptability of the mobile application by patients and clinicians and to assess preliminary postoperative opioid use and misuse patterns to inform future directions. Participants (N = 9) were women between the ages of 23 and 41 years old who underwent a repeat cesarean section at an inner-city academic hospital and were without a history of self-reported opioid use. Participants received a tablet loaded with the mobile application and electronic pill packs with the standard postoperative prescription of 14 Roxicodone tablets. On review, 53% of opioids were unused. Four patients took four or fewer Roxicodone pills, with three patients taking none. Additionally, three were noted to have aberrant behavior that was inconsistent with prescribed instructions provided to the patient by the provider. Results of this feasibility study suggest that the CPM mobile application is feasible and acceptable for both patients and practitioners and provides traceability for clinicians to make better-informed decisions regarding patient care. Preliminary data suggest an excess of prescribed narcotics as well as a potential concern for utilization of medication not as prescribed.

The use of technology-based adherence monitoring in the treatment of hepatitis C virus.

Direct-acting antivirals (DAAs) achieve high hepatitis C virus (HCV) cure rates and are forgiving to missed doses, but adherence–efficacy relationships have not been well defined. Traditional adherence measures (e.g. pill counts, self-report and pharmacy refills) over-estimate medication adherence. Newer technology-based tools have been used to provide more objective adherence data. Herein, electronic medication diaries (e-diaries), medication events monitoring system (MEMS®) caps, electronic blister packs, electronic pill boxes, video-based directly observed therapy (vDOT), artificial intelligence platforms (AIPs), and ingestible sensor systems are described, and compared based on existing studies using DAA. Percent adherence, predictors of adherence, and HCV cure rates utilizing these technologies are included. DAA adherence with e-diaries was 95–96%, MEMS® caps and ingestible biosensors were between 95% and 97%, blister pack weekly dosing ranged 73–98%, and daily dosing 73–94%, whereas electronic pill boxes ranged between 39% and 89%, vDOT was 98% and AIP 91–96%. Despite a wide range of adherence, high sustained virologic response (SVR) rates (86–100%) were observed across all studies utilizing these different technology-based tools. Current data support the forgiveness of DAA therapies to missed doses using tools that provide more quantitative adherence measures compared with self-report and provide insight on adherence–efficacy relationships for contemporary DAA.

Risk Indicators Improve the Prescription Quality of Drugs with Anticholinergic Properties in Nursing Homes.

Aim: The objective of this study was to assess the impact of a collaborative therapeutic optimization program on the rate of potentially inappropriate prescription of drugs with anticholinergic properties in nursing homes. Methods: Quasi-experimental study in 37 nursing homes in France. The intervention included the use of quality indicators for prescriptions combined with educational sessions and dedicated materials for nursing home staff (unlimited access to study material for staff, including nurses, general practitioners, pharmacists). Indicators were calculated based on routine data collected from an electronic pill dispenser system. The primary outcome was the presence of at least one prescription containing ≥1 drug from a list of 12 drugs with anticholinergic properties. A difference-in-differences analysis was conducted at 18 months as well as propensity score weighting to minimize any potential indication bias. A generalized estimating equation model estimated the probability of being prescribed at least one target drug at any time during a 9-month period for each resident. Results: In total, 33 nursing homes (intervention group: n = 10; control group: n = 23) were included, totalling 8137 residents. There was a decrease in the use of drugs with anticholinergic properties over time in both groups, as well as a decline in the intervention group compared to the control group (Odds Ratio: 0.685, 95% CI: 0.533, 0.880; p < 0.01) that was attributable to the intervention. An estimated 49 anticholinergic properties drug prescriptions were avoided by the intervention. Conclusion: This study found that an intervention based on indicators derived from routine prescription data was effective in reducing use of drugs with anticholinergic properties prescriptions in nursing homes.

European Network to Advance Best Practices and Technology on Medication Adherence: Mission Statement.

Medication non-adherence is associated with almost 200,000 deaths annually and €80–125 billion in the European Union. Novel technological advances (smart pill bottles, digital inhalers and spacers, electronic pill blisters, e-injection pens, e-Health applications, big data) could help managing non-adherence. Healthcare professionals seem however inadequately informed about non-adherence, availability of technological solutions in daily practice is limited, and collaborative efforts to push forward their implementation are scarce. The European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE, COST Action 19132) aims to 1) raise awareness of adherence enhancing solutions, 2) foster knowledge on medication adherence, 3) accelerate clinical application of novel technologies and 4) work collaboratively towards economically viable policy, and implementation of adherence enhancing technology across healthcare systems.

Electronic pill bottles to monitor and promote medication adherence for people with multiple sclerosis: A randomized, virtual clinical trial

ObjectiveWe perform a randomized trial to test the impact of electronic pill bottles with audiovisual reminders on oral disease modifying therapy (DMT) adherence in people with MS (PwMS). MethodsAdults with multiple sclerosis (MS) taking an oral DMT were randomized 1:1 for 90 days to remote smartphone app- and pill bottle-based (a) adherence monitoring, or (b) adherence monitoring with audiovisual medication reminders. Optimal adherence was defined as the proportion of doses taken ±3 h of the scheduled time. Numbers of missed pills and pills taken early, on time, late, and extra were recorded. A multivariable regression model tested possible associations between optimal adherence and age, MS duration, cognitive functioning, and number of daily prescription pills. Results85 participants (66 female; mean age 44.9 years) took dimethyl/diroximel fumarate (n = 49), fingolimod (n = 26), or teriflunomide (n = 10). Optimal adherence was on average higher in the monitoring with reminders arm (71.4%) than the monitoring only arm (61.6%; p = 0.033). In a multivariable model, optimal adherence was less likely in younger participants (p < 0.001) and those taking more daily prescription pills (p < 0.001). In the monitoring only arm, 4.0% of doses were taken early, 61.6% on time, 5.6% late, 4.4% in excess, and 24.4% were missed. In the reminders arm, these proportions were 3.4%, 71.4%, 3.7%, 8.7%, and 12.8%, respectively. ConclusionWe map real-world oral DMT adherence patterns using mHealth technology. PwMS who received medication reminders had higher optimal adherence. Nonadherence was more nuanced than simply missing pills. Developing strategies to improve adherence remains important in longitudinal MS care.

Adjunct interventions to standard medical management of buprenorphine in outpatient settings: A systematic review of the evidence

BackgroundA growing body of research has examined adjunctive interventions supportive of engagement and retention in treatment among patients receiving buprenorphine for opioid use disorder (OUD). We conducted a systematic review of the literature addressing the effect on key outcomes of adjunctive interventions provided alongside standard medical management of buprenorphine in outpatient settings. MethodsWe included prospective studies examining adults receiving buprenorphine paired with an adjunctive intervention for the treatment of OUD in an outpatient setting. Data sources included Medline, Cochrane Central Register of Controlled Trials, CINAHL and PsycINFO from inception through January 2020. Two raters independently reviewed full-text articles, abstracted data and appraised risk of bias. Outcomes examined included abstinence, retention in treatment and non-addiction-related health outcomes. ResultsThe final review includes 20 manuscripts, 11 randomized control trials (RCTs), three secondary analyses of RCTs and six observational studies. Most studies examined psychosocial interventions (n = 14). Few examined complementary therapies (e.g., yoga; n = 2) or technological interventions (e.g., electronic pill dispensation; n = 3); one study examined an intervention addressing structural barriers to care (patient navigators; n = 1). Low risk of bias RCTs found no evidence that adding psychosocial interventions to buprenorphine treatment improves substance use outcomes. ConclusionsResearch is needed to identify adjunctive interventions with potential to support medication adherence and addiction-related outcomes for patients engaged in buprenorphine treatment. Data from clinical trials suggest that lack of ready access to psychosocial treatments should not discourage clinicians from prescribing buprenorphine.

Assessment of a strategy combining ambulatory blood pressure, adherence monitoring and a standardised triple therapy in resistant hypertension

Purpose Poor adherence to drug therapy and inadequate drug regimens are two frequent factors responsible for the poor blood pressure (BP) control observed in patients with apparent resistant hypertension. We evaluated the efficacy of an antihypertensive management strategy combining a standardised therapy with three long acting drugs and electronic monitoring of drug adherence in patients with apparent resistant hypertension. Materials and Methods In this multicentric observational study, adult patients with residual hypertension on 24 h ambulatory BP monitoring (ABMP) despite the use of three or more antihypertensive drugs could be included. Olmesartan/amlodipine (40/10 mg, single pill fixed-dose combination) and chlorthalidone (25 mg) were prescribed for 3 months in two separated electronic pills boxes (EPB). The primary outcome was 24 h ambulatory systolic BP (SBP) control at 3 months, defined as mean SBP <130 mmHg. Results We enrolled 48 patients (36.0% women) of whom 35 had complete EPB data. After 3 months, 52.1% of patients had 24 h SBP <130 mmHg. 24 h SBP decreased by respectively −9.1 ± 15.5 mmHg, −22.8 ± 30.6 mmHg and −27.7 ± 16.6 mmHg from the tertile with the lowest adherence to the tertile with the highest adherence to the single pill combination (p = 0.024). A similar trend was observed with tertiles of adherence to chlorthalidone. Adherence superior to 90% was associated with 24 h systolic and diastolic blood pressure control in multiple logistic regression analysis (odds ratio = 14.1 (95% confidence interval 1.1–173.3, p = 0.039). Conclusions A simplified standardised antihypertensive therapy combined with electronic monitoring of adherence normalises SBP in about half of patients with apparent resistant hypertension. Such combined management strategy enables identifying patients who need complementary investigations and those who rather need a long-term support of their adherence.

Association of Hispanic ethnicity and linguistic acculturation with cardiovascular medication adherence in patients with suspected acute coronary syndrome.

Despite a higher prevalence of cardiovascular disease (CVD) risk factors, Hispanic-Americans have lower rates of CVD-related and all-cause mortality, as well as higher life expectancy than non-Hispanic whites – a phenomenon known as the Hispanic health paradox. However, this survival benefit attenuates with increased acculturation to Western lifestyles, potentially due to adoption of unhealthy behaviors. Accordingly, we assessed whether Hispanic ethnicity and linguistic acculturation, as measured by English proficiency, were associated with nonadherence to cardiovascular medications. We enrolled patients presenting to an academic medical center emergency department with suspected acute coronary syndrome between May 2014 and November 2017. Ethnicity, native language, and English proficiency were self-reported. Cardiovascular medication adherence was assessed using an electronic pill bottle that recorded the date and time of each bottle opening. Generalized linear models with a logit link were used to examine the association of Hispanic ethnicity and English proficiency with daily cardiovascular medication adherence, adjusting for demographics, comorbidities, and dosing frequency of the electronically-monitored medication. Among 332 included patients, mean age was 61.68 ± 12.05 years, 43.07% were women, and 62.95% were Hispanic, of whom 80.38% were native Spanish-speakers. Overall, Hispanics had higher odds of medication adherence than non-Hispanics (adjusted OR 1.31, 95% CI 1.16–1.49, p < 0.001). However, among native Spanish-speaking Hispanics, greater English proficiency was associated with lower odds of medication adherence (adjusted OR 0.80 per 1-point increase in English proficiency, 95% CI 0.75–0.86, p < 0.001). Although Hispanics had better medication adherence than non-Hispanics overall, increased linguistic acculturation among native Spanish-speakers was associated with worse adherence behaviors.

Electronic pill bottle monitoring versus reminders to promote medication adherence for people with multiple sclerosis: A randomized, virtual clinical trial

Electronic pill bottle monitoring versus reminders to promote medication adherence for people with multiple sclerosis: A randomized, virtual clinical trial

Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk factor: Protocol of a RCT

BackgroundGeographical and racial disparities in stroke outcomes are especially prominent in the Southeastern United States, which represents a region more heavily burdened with stroke compared to the rest of the country. While stroke is eminently preventable, particularly via blood pressure control, fewer than one third of patients with a stroke have their blood pressure controlled ≥ 75% of the time, and low consistency of blood pressure control is linked to higher stroke risk. ObjectiveTo demonstrate that a mHealth technology-centered, integrated approach can effectively improve sustained blood pressure control among stroke patients (half of whom will be Black). DesignThe Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor is a prospective randomized controlled trial, which will include a cohort of 200 patients with a stroke, encountered at two major safety net health care systems in South Carolina. The intervention comprises utilization of a Vaica electronic pill tray & blue-toothed UA-767Plus BT blood pressure device and a dedicated app installed on patients’ smart phones for automatic relay of data to a central server. Providers will follow care protocols based on expert consensus practice guidelines to address optimal blood pressure management. Study outcomesPrimary outcome is systolic blood pressure at 12-months, which is the major modifiable step to stroke event rate reduction. Secondary endpoints include control of other stroke risk factors, medication adherence, functional status, and quality of life. DiscussionWe anticipate that a successful intervention will serve as a scalable model of effective chronic blood pressure management after stroke, to bridge racial and geographic disparities in stroke outcomes in the United States. Trial registrationClinicalTrials.gov - NCT03401489

Telemonitored Human Circadian Temperature Dynamics During Daily Routine.

BackgroundCircadian rhythms in body temperature coordinate peripheral molecular clocks, hence they could potentially predict optimal treatment timing (chronotherapy) in individual patients. Circadian parameters in chest surface body temperature (Chesttemp) were recorded remotely and in real time through the use of wearable sensors.MethodsThe dynamics of circadian oscillations in Chesttemp and core body temperature (Coretemp) and their moderation by sex and age were analysed in 38 men and 50 women, aged 21–78 years. In two studies (ST1 and ST2), Chesttemp was measured every minute and teletransmitted using a BLE-connected sensor for 3.6–28.3 days. Additionally, in ST2, Coretemp was recorded per minute in 33 age- and sex-stratified subjects using electronic ingestible pills with radio-frequency transmissions. Circadian parameters were computed using spectral analysis and cosinor modelling. The temporal relations between Chesttemp and Coretemp cosinor parameters were summarised with principal component (PC) analysis. The effect of sex and age was analysed through multivariate regression.ResultsUsing spectral analysis, a dominant period of 24- or 12-h was identified in 93.2% of the Chesttemp and in 100% of the Coretemp time series. The circadian parameters varied largely between-subjects both for Chesttemp (ranges: mesors, 33.2–36.6°C; amplitudes, 0.2–2.5°C; acrophases, 14:05–7:40), and Coretemp (mesors, 36.6–37.5°C; amplitudes, 0.2–0.7°C; bathyphases, 23:50–6:50). Higher PC loadings mainly corresponded to (i) large Chesttemp amplitudes, and phase advance of both temperature rhythms for the first PC (PC1, 27.2% of variance var.), (ii) high mesors in both temperature rhythms for PC2 (22.4% var.), and (iii) large Coretemp amplitudes for PC3 (12.9% var.). Chesttemp and Coretemp mesors and PC2 loadings decreased in females, while remaining quite stable in males as a function of age. In contrast, Coretemp amplitude and PC3 loadings increased with age in females, but decreased in males. Finally, older subjects, both female and male, displayed a reduction in ultradian variabilities, and an increase in both Chesttemp circadian amplitude and PC1 loadings.InterpretationThe dynamics relations between Chesttemp and Coretemp rhythms were largely moderated by age and sex, with results suggesting that treatment timing could be most critical for therapeutic index in women and in order people.

Qualitative Exploration of Barriers to Statin Adherence and Lipid Control

Financial incentives may improve health by rewarding patients for focusing on present actions-such as medication regimen adherence-that provide longer-term health benefits. To identify barriers to improving statin therapy adherence and control of cholesterol levels with financial incentives and insights for the design of future interventions. This qualitative study involved retrospective interviews with participants in a preplanned secondary analysis of a randomized clinical trial of financial incentives for statin therapy adherence. A total of 636 trial participants from several US insurer or employer populations and an academic health system were rank ordered by change in low-density lipoprotein cholesterol (LDLC) levels. Participants with the most LDLC level improvement (high-improvement group) and those with LDLC levels that did not improve (nonimprovement group) were purposively targeted, stratified across all trial groups, for semistructured telephone interviews that were performed from April 1 to June 30, 2018. Interviews were coded using a team-based, iterative approach. Data were analyzed from July 1, 2018, to October 31, 2020. The primary outcome was mean change in LDLC level from baseline to 12 months; the secondary outcome, statin therapy adherence during the first 6 months. A total of 54 patients were interviewed, divided equally between high-improvement and nonimprovement groups, with a mean (SD) age of 43.5 (10.3) years; 36 (66.7%) were women, 28 (51.9%) had diabetes, and 18 (33.3%) had cardiovascular disease. Compared with the high-improvement group, the nonimprovement group had fewer interviewees with an annual income of greater than $50 000 (11 [40.7%] vs 22 [81.5%]), worse self-reported health (fair to poor, 13 [48.1%] vs 3 [11.1%]), more Black interviewees (16 [59.3%] vs 4 [14.8%]), and lower baseline LDLC levels (>160 mg/dL, 2 [7.4%] vs 25 [92.6%]). Participants in the nonimprovement group had a greater burden of chronic illness (≥2 chronic conditions, 13 [48.1%] vs 6 [22.2%]) and were less frequently employed (full-time, 6 [22.2%] vs 12 [44.4%]). In interviews, the nonimprovement group was less focused on risks of high LDLC levels, described less engagement in LDLC level management, articulated fewer specific nutritional choices for optimizing health, and recounted greater difficulty obtaining healthy food. Participants in both groups had difficulty describing the structure of the financial incentives but did recall features of the electronic pill containers used to track adherence and how those containers affected medication routines. Participants in a statin adherence trial whose LDLC levels did not improve found it more difficult to create medication routines and respond to financial incentives in the context of complex living conditions and a high burden of chronic illness. These findings suggest that future studies should be more attentive to socioeconomic circumstances of trial participants. ClinicalTrials.gov Identifier: NCT01798784.

Brief Report: Financial Incentives and Real-Time Adherence Monitoring to Promote Daily Adherence to HIV Treatment and Viral Suppression Among People Living With HIV: A Pilot Study.

Interventions to promote medication adherence and viral suppression are needed among HIV-positive individuals. We aimed to determine the feasibility, acceptability, and preliminary impact of daily financial incentives linked to real-time adherence monitoring among treatment-experienced individuals. At an HIV clinic in Philadelphia, we conducted a pilot randomized trial among treatment-experienced HIV-positive adults with unsuppressed viral loads (>400 copies/mL). Participants randomized to the intervention group were eligible for daily lottery-based financial rewards dependent on antiretroviral therapy (ART) adherence, measured by a wireless-enabled electronic pill bottle. Participants also received a financial incentive for achieving viral suppression at 3 months. The control group received the standard of care. We measured acceptance and feasibility through follow-up survey at 3 months, viral suppression at 3 months, and adherence. Among 29 participants, 28 (93%) completed 3-month follow-up, and 24 (83%) completed a 3-month laboratory visit. Electronic pill bottles were highly acceptable to participants, with most strongly agreeing that they worked well, were reliable, and easy to use. Among those who received the intervention, 77% were very satisfied with their experience. Among those who completed the 3-month laboratory visit, viral suppression was achieved by 40% in the intervention group and 29% in the control group. ART adherence ≥80% was achieved by 36% and 25% in the intervention and control groups, respectively. Daily financial incentives coupled with real-time adherence monitoring are a promising strategy to support ART adherence among HIV-positive individuals who are not virally suppressed. This novel approach warrants testing in a larger trial.

Adherence to oral antibiotic therapy in patients with bone and joint infection: A pilot study

ObjectivesThe management of bone and joint infections (BJI) is complex and requires prolonged antimicrobial therapy. Few data exist on adherence to anti-infectious treatment other than HIV, and none on BJI, even though compliance is considered as a major determinant of clinical outcome. This work aimed at evaluating adherence to oral antimicrobial treatment in patients with BJI. Patients and methodsThis is a prospective observational blinded pilot study evaluating adherence by a 6-item questionnaire at 6 weeks (W6) and 3 months (M3) post-surgery. The primary endpoint was the proportion of patients with high, moderate and poor adherence at W6. Secondary endpoints included change in adherence between W6 and M3, and the exploration of potential variables influencing adherence. ResultsAnalysis was performed on 65 questionnaires obtained from 43 patients including 35 with device-associated BJI. At W6, 11 out of 34 patients were highly adherent to oral antibiotic therapy, 22 moderately adherent and 1 poorly adherent. There was no significant change in adherence to antibiotic therapy between W6 and M3. The only variable significantly associated with the level of adherence at W6 and M3 was the number of daily doses of antibiotic (P=0.04 and 0.02 at W6 and M3, respectively). ConclusionsThis study provided a snapshot of patients’ adherence in BJI. Adherence to antibiotic therapy appeared to be stable up to 3 months and a higher number of daily doses of antibiotic was associated with poorer adherence. These observations need to be confirmed in future large-scale studies using electronic pill monitoring systems.

Analysis and monitoring of a sensor-pill using DQPSK, with advanced virtual instrumentation

Recording vital parameters of the internal parts of our human body is complex and challenging, so to get the exact or the accurate value we do the approximation of the data. Now to bridge this gap of accurate and approximate, technology has now taken a huge jump, and have come forward with something known as swallowable sensor pill. Although, we can not imagine of swallowing anything other than food items but still it is working. The electronic pill (e-pill) discussed in this model already exists, and works on a complete wireless independent system, on a two-way synchronous DQPSK technique using low carrier frequency of 150-300 kHz suited for human body. This small system is incorporated in a small swallow able pill, powered by a special 3v button cell. The received body vital signals, i.e., temperature, SpO2 level, pH value, etc., will be live monitored and analysed using the biomedical toolkit of LabVIEW 8.5, in addition to it a comparative chart of more than one patient can be made for comparative analysis.

Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer

IntroductionPatient adherence to adjuvant endocrine therapy (AET) after a diagnosis of hormone-sensitive breast cancer is poor. Previous interventions have failed to produce changes in adherence, address patient preferences or include...

Successful Transitions to Remote Assessments and Technology Installations due to COVID-19: The I-CONECT Project

I-CONECT is a randomized controlled clinical trial to examine the impact of social interaction delivered via video-chat on cognitive function (clinicaltrials.gov number: NCT02871921, project website: www.I-CONECT.org ). We aimed to enroll 320 community-dwelling socially isolated older adults (age >=75 years). The recruitment of participants has started in 2018 and was ongoing when COVID-19 pandemic began. Video chat and telephone-based social interaction interventions did not change during COVID-19. However, new recruitment and cognitive assessments, which require in-person contact and deployment and retrieval of video chat devices in participant homes, were suspended due to the nature of our study population (i.e., older age, higher likelihood of comorbidities). Recently we were able to successfully switch to complete remote assessments including 1) telephone-based cognitive assessments using T-COG (Telephone Cognitive Assessment battery), and 2) contactless delivery of our study devices (Chrome books and electronic pill boxes) for subject self-installation. Our creative approach to self-installations includes color coded pictures and an easy-to-follow installation manual, accompanied by remote instruction and support via telephone. This poster introduces our remote assessment and installation protocol and participant and technical support team feedback regarding this new contactless protocol. This presentation provides useful guidance for future studies considering completely remote assessment and telemedicine approaches.

Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp)

BackgroundPoor adherence to antiretroviral therapy (ART) is one of the primary barriers to viral load suppression. mHealth technology can help overcome challenges with ART adherence. This paper outlines the protocol for the WiseApp randomized control trial. The WiseApp contains real-time medication monitoring linking an electronic pill bottle and fitness tracker to the app, helping persons living with HIV (PLWH) self-manage their medication adherence and improve their overall quality of life. The primary objective of the trial is to test the effect of the WiseApp's medication adherence features on antiretroviral adherence in underserved PLWH in New York City.MethodsThis ongoing study is a two-arm randomized control trial. Participants are randomized 1:1 to the WiseApp intervention arm or the control arm at baseline and followed for 6 months. Eligibility criteria include: 18 years of age, have a diagnosis of HIV, speak and understand English or Spanish, live in the United States, own a smartphone, currently taking ART medications, and report the past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL. The sample size for the trial is 200 people. All study participants receive the WiseApp, a CleverCap electronic pill bottle, and a fitness tracker. The intervention group also receives videos and health surveys centered on medication adherence and managing living with HIV as well as medication reminders. In contrast, the control group receives walk step reminders, videos, and surveys focused on overall wellness.DiscussionThe WiseApp Trial has the potential to improve HIV self-management applications, being one of the few randomized controlled trials of a mHealth medication adherence and HIV self-management application in the United States. The trial could also bring new opportunities for advancement in reaching economically disenfranchised and underserved populations in the United States. The real-time monitoring of the WiseApp has the potential to help providers initiate interventions to help patients resume treatment before drug resistance begins.Trial registrationThis trial was registered with ClinicalTrials.gov (NCT03205982) on July 2, 2017.

Daily text message assessments of 6-mercaptopurine adherence and its proximal contexts in adolescents and young adults with leukemia: A pilot study.

This pilot study explored the feasibility and acceptability of implementing text-based assessments of oral chemotherapy adherence in adolescents and young adults (AYA) with leukemia. AYA prescribed maintenance 6-mercaptopurine (6MP) received daily text message surveys and utilized an electronic pill bottle for 28days. Text surveys assessed 6MP adherence and contextual associates (eg, mood). Feasibility was defined by recruitment/retention rates, survey completion rates, cost, and technical issues. After the 28-day period, AYA completed an acceptability survey. Secondary analyses compared text survey and electronic pill bottle adherence rates, and explored the daily associations between contextual factors and 6MP nonadherence. Eighteen AYA enrolled (M age=18, range 15-22) and completed study procedures (100% recruitment and retention rates). Adherence survey completion rates were high (M=88.9%), the technology cost was $204.00, and there were few technical issues. AYA reported high satisfaction with the surveys and perceived them as a helpful medication reminder. While not significantly correlated, survey and electronic pill bottle adherence data converged on the majority of days (>90%). Exploratory analyses showed that AYA were more likely to miss a dose of 6MP on weekends (OR=2.33, P=.048) and on days when their adherence motivation (OR=0.28, P=.047) and negative affect (OR=3.92, P=.02) worsened from their own typical functioning. For AYA with leukemia, daily text-based surveys are a feasible and acceptable method for delivering medication adherence assessments, and may operate as a short-term intervention. To develop personalized mobile health interventions, findings also highlighted the need to study time-varying predictors of 6MP nonadherence.

Effect of Patient Financial Incentives on Statin Adherence and Lipid Control

Financial incentives can improve medication adherence and cardiovascular disease risk, but the optimal design to promote sustained adherence after incentives are discontinued is unknown. To determine whether 6-month interventions involving different financial incentives to encourage statin adherence reduce low-density lipoprotein cholesterol (LDL-C) levels from baseline to 12 months. This 4-group, randomized clinical trial was conducted from August 2013 to July 2018 among several large US insurer or employer populations and the University of Pennsylvania Health System. The study population included adults with elevated risk of cardiovascular disease, suboptimal LDL-C control, and evidence of imperfect adherence to statin medication. Data analysis was performed from July 2017 to June 2019. The interventions lasted 6 months during which all participants received daily medication reminders and an electronic pill bottle. Statin adherence was measured by opening the bottle. For participants randomized to the 3 intervention groups, adherence was rewarded with financial incentives. The sweepstakes group involved incentives for daily adherence. In the deadline sweepstakes group, incentives were reduced if participants were adherent only after a reminder. The sweepstakes plus deposit contract group split incentives between daily adherence and a monthly deposit reduced for each day of nonadherence. The primary outcome was change in LDL-C level from baseline to 12 months. Among 805 participants randomized (199 in the simple daily sweepstakes group, 204 in the deadline sweepstakes group, 201 in the sweepstakes plus deposit contract group, and 201 in the control group), the mean (SD) age was 58.5 (10.3) years; 519 participants (64.5%) were women, 514 (63.9%) had diabetes, and 273 (33.9%) had cardiovascular disease. The mean (SD) baseline LDL-C level was 143.2 (42.5) mg/dL. Measured adherence at 6 months (defined as the proportion of 180 days with electronic pill bottle opening) in the control group (0.69; 95% CI, 0.66-0.72) was lower than that in the simple sweepstakes group (0.84; 95% CI, 0.81-0.87), the deadline sweepstakes group (0.86; 95% CI, 0.83-0.89), and the sweepstakes plus deposit contract group (0.87; 95% CI, 0.84-0.90) (P < .001 for each incentive group vs control). LDL-C levels were measured for 636 participants at 12 months. Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL (95% CI, 28.4-38.8 mg/dL) in the control group, 32.4 mg/dL (95% CI, 27.3-37.6 mg/dL) in the sweepstakes group, 33.2 mg/dL (95% CI, 28.1-38.3 mg/dL) in the deadline sweepstakes group, and 36.5 mg/dL (95% CI, 31.3-41.7 mg/dL) in the sweepstakes plus deposit contract group (adjusted P > .99 for each incentive group vs control). Compared with the control group, different financial incentives improved measured statin adherence but not LDL-C levels. This result points to the importance of directly measuring health outcomes, rather than simply adherence, in trials aimed at improving health behaviors. ClinicalTrials.gov Identifier: NCT01798784.