Electronic Pill Bottle Research Articles

Effects of Adjuvant Endocrine Therapy-Specific Perceptions on Response to a Behavioral Intervention for Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer.

Adjuvant endocrine therapy (AET) is a life-saving medication for patients with hormone-sensitive breast cancer, yet many struggle with adherence, warranting behavioral intervention. In our recent trial, participation in a group cognitive behavioral intervention (STRIDE) for symptom management and adherence was associated with improvements in symptom distress, coping, quality of life, and mood. We now explore whether baseline patient- and medication-specific factors-which may be modifiable by clinician-led discussions-moderated the effect of STRIDE on adherence rates. From October 2019 to June 2021, 100 patients with early-stage breast cancer reporting AET-related distress were enrolled and randomly assigned to STRIDE or a medication monitoring (MM) control group. All patients stored their AET in electronic pill bottles to track objective adherence. Patients also self-reported their adherence on the Medication Adherence Report Scale-5 and their perceptions of AET on the Cancer Therapy Satisfaction Questionnaire at baseline. We conducted hierarchical linear modeling to test moderators of intervention effects on objective adherence rates. We report the time × group × moderator effects. Among patients reporting greater perceived difficulties with AET adherence at baseline, STRIDE participants had higher adherence rates over time compared with MM (b = -13.80; SE = 4.56; P < .01). Patients with greater expectations of therapeutic benefit from AET also had improved adherence rates if they were assigned to STRIDE, versus MM (b = 0.25; SE = 0.10; P = .01). Patients who perceived taking AET as convenient and had been taking their AET for less time had higher adherence rates in STRIDE, versus MM. The current study identified patient- and medication-specific factors that may augment AET adherence interventions and may be modifiable through clinician-led discussions, such as perceptions of adherence problems, therapeutic efficacy, and convenience of AET.

Leveraging Habits to Improve Adherence to Gout Medications: A Qualitative Study.

This study investigates patients' medication-taking routines and the feasibility of harnessing habit formation through context cues and rewards to improve medication adherence. Semistructured qualitative interviews with patients with gout from an urban health care system were conducted to explore typical medication-taking behavior, experiences using electronic pill bottles, barriers to adherence, existing context cues, and potential cues and rewards for habit-forming behavior. Medication-taking patterns were recorded for six weeks using electronic pill bottles before interviews to inform discussion. Transcribed interviews were analyzed to generate themes using codes developed by the study team, with representative quotations selected as illustrations. We conducted interviews with 15 individuals (mean age 60.6 [SD 20.3] years, three women [20%], and nine White patients [60%]). Pill bottle-recorded adherence to urate-lowering therapy (ULT) was high (mean 0.91[SD 0.10]), and one patient was experiencing an active gout flare. Five key themes emerged: (1) reasons for nonadherence, (2) internal and external motivations for adherence, (3) structured routines around taking medications, (4) rewards for good medication adherence, and (5) the role of pill cap technology in medication-taking. The importance of a predictable, structured routine in which participants could incorporate their medication-taking behavior emerged as a key factor that promoted consistent adherence. Further, identifying context cues and reminders seemed to promote incorporation of medication-taking into routines. Therefore, habit-based interventions that use context cues to establish routines around medication-taking may be a feasible strategy to improve adherence in patients with chronic conditions such as gout.

The impact of using reinforcement learning to personalize communication on medication adherence: findings from the REINFORCE trial

Text messaging can promote healthy behaviors, like adherence to medication, yet its effectiveness remains modest, in part because message content is rarely personalized. Reinforcement learning has been used in consumer technology to personalize content but with limited application in healthcare. We tested a reinforcement learning program that identifies individual responsiveness (“adherence”) to text message content and personalizes messaging accordingly. We randomized 60 individuals with diabetes and glycated hemoglobin A1c [HbA1c] ≥ 7.5% to reinforcement learning intervention or control (no messages). Both arms received electronic pill bottles to measure adherence. The intervention improved absolute adjusted adherence by 13.6% (95%CI: 1.7%–27.1%) versus control and was more effective in patients with HbA1c 7.5- < 9.0% (36.6%, 95%CI: 25.1%–48.2%, interaction p < 0.001). We also explored whether individual patient characteristics were associated with differential response to tested behavioral factors and unique clusters of responsiveness. Reinforcement learning may be a promising approach to improve adherence and personalize communication at scale.

Evaluating the Efficacy of Connected Healthcare: An Empirical Examination of Patient Engagement Approaches and Their Impact on Readmission

Connected healthcare is a form of health delivery that connects patients and providers through connected health devices, allowing providers to monitor patient behavior and proactively intervene before an adverse event occurs. Unlike the costs, the benefits of connected healthcare in improving patient behavior and health outcomes are usually difficult to determine. In this study, we examine the efficacy of a connected health system that aimed to reduce readmissions through improved medication adherence. Specifically, we study 975 patients with heart disease who received electronic pill bottles that tracked medication adherence. Patients who were nonadherent received active social support that involved different types of feedback, such as text messages and calls. By integrating data on adherence, intervention, and readmission, we aim to (1) investigate the efficacy of connected healthcare in promoting medication adherence, (2) examine the relationship between medication adherence and readmission, and (3) develop a dynamic readmission risk-scoring model that considers medication adherence and use the model to better target nonadherent patients. Our findings suggest that patients are more likely to become adherent when they or their partners receive high levels of intervention that involve personalized feedback and when the intervention is escalated quickly and consistently. We also find that long-term adherence to three common heart medications is strongly associated with reduced readmission risk. Lastly, using counterfactual simulation, we apply the dynamic readmission risk-scoring model to our setting and find that, when using an intervention strategy that prioritizes high-risk patients, we obtain 10% fewer readmissions while using the same effort level from the patient support team. This paper was accepted by Jayashankar Swaminathan, operations management. Funding: The randomized, controlled trial was funded by the Center for Medicare &amp; Medicaid Innovation [Healthcare Innovation Award 1C1CMS331009]. Supplemental Material: The data files are available at https://doi.org/10.1287/mnsc.2023.4865 .

Remote Monitoring and Behavioral Economics in Managing Heart Failure in Patients Discharged From the Hospital

Close remote monitoring of patients following discharge for heart failure (HF) may reduce readmissions or death. To determine whether remote monitoring of diuretic adherence and weight changes with financial incentives reduces hospital readmissions or death following discharge with HF. The Electronic Monitoring of Patients Offers Ways to Enhance Recovery (EMPOWER) study, a 3-hospital pragmatic trial, randomized 552 adults recently discharged with HF to usual care (n = 280) or a compound intervention (n = 272) designed to inform clinicians of diuretic adherence and changes in patient weight. Patients were recruited from May 25, 2016, to April 8, 2019, and followed up for 12 months. Investigators were blinded to assignment but patients were not. Analysis was by intent to treat. Participants randomized to the intervention arm received digital scales, electronic pill bottles for diuretic medication, and regret lottery incentives conditional on the previous day's adherence to both medication and weight measurement, with $1.40 expected daily value. Participants' physicians were alerted if participants' weights increased 1.4 kg in 24 hours or 2.3 kg in 72 hours or if diuretic medications were missed for 5 days. Alerts and weights were integrated into the electronic health record. Participants randomized to the control arm received usual care and no further study contact. Time to death or readmission for any cause within 12 months. Of the 552 participants, 290 were men (52.5%); 291 patients (52.7%) were Black, 231 were White (41.8%), and 16 were Hispanic (2.9%); mean (SD) age was 64.5 (11.8) years. The mean (SD) ejection fraction was 43% (18.1%). Each month, approximately 75% of participants were 80% adherent to both medication and weight measurement. There were 423 readmissions and 26 deaths in the control group and 377 readmissions and 23 deaths in the intervention group. There was no significant difference between the 2 groups for the combined outcome of all-cause inpatient readmission or death (unadjusted hazard ratio, 0.91; 95% CI, 0.74-1.13; P = .40) and no significant differences in all-cause inpatient readmission or observation stay or death, all-cause cardiovascular readmission or death, time to first event, and total all-cause deaths. Participants in the intervention group were slightly more likely to spend fewer days in the hospital. In this randomized clinical trial, there was no reduction in the combined outcome of readmission or mortality in a year-long intensive remote monitoring program with incentives for patients previously hospitalized for HF. ClinicalTrials.gov Identifier: NCT02708654.

Impact of hydroxyurea dose and adherence on hematologic outcomes for children with sickle cell anemia.

Hydroxyurea is the primary treatment for sickle cell anemia (SCA), yet real-world implementation in high-income settings is suboptimal. Variation in prescribed hydroxyurea dose and patient adherence in these settings can both affect actual exposure to hydroxyurea. Quantifying the contributions of hydroxyurea dose and medication adherence to the relationship between hydroxyurea exposure and hematologic parameters could inform strategies to optimize exposure and improve outcomes. We evaluated the relationship between hydroxyurea exposure, defined by average prescribed dose and adherence, and hematologic parameters using data from children with SCA who were enrolled in two prospective hydroxyurea adherence studies. Hydroxyurea adherence was assessed by video directly observed therapy or electronic pill bottle and medication administration record. Average prescribed dose was abstracted from prescriptions in patients' electronic medical record. Participants with a hydroxyurea exposure >20mg/kg/day and ≤20mg/kg/day were included in the higher and lower exposure groups, respectively. Forty-five participants were included in the analysis (56% male; median age 12years [range 2-19]; 98% Black). Higher exposed participants (n=23) were prescribed a higher dose (27.2 vs. 24.4mg/kg/day, p=.002) and had better adherence (0.92 vs. 0.71, p≤.001) compared to lower exposed participants (n=22). Higher exposure was associated with higher fetal hemoglobin (p=.04) and mean corpuscular volume (p=.02). Higher hydroxyurea exposure is associated with improved hematologic parameters in the high-income setting and is affected by both prescribed dose and adherence. Future studies are needed to optimize both adherence and hydroxyurea prescribing and confirm that increasing exposure improves clinical outcomes in this setting.

Technologies for Medication Adherence Monitoring and Technology Assessment Criteria: Narrative Review.

BackgroundAccurate measurement and monitoring of patient medication adherence is a global challenge because of the absence of gold standard methods for adherence measurement. Recent attention has been directed toward the adoption of technologies for medication adherence monitoring, as they provide the opportunity for continuous tracking of individual medication adherence behavior. However, current medication adherence monitoring technologies vary according to their technical features and data capture methods, leading to differences in their respective advantages and limitations. Overall, appropriate criteria to guide the assessment of medication adherence monitoring technologies for optimal adoption and use are lacking.ObjectiveThis study aims to provide a narrative review of current medication adherence monitoring technologies and propose a set of technology assessment criteria to support technology development and adoption.MethodsA literature search was conducted on PubMed, Scopus, CINAHL, and ProQuest Technology Collection (2010-present) using the combination of keywords medication adherence, measurement technology, and monitoring technology. The selection focused on studies related to medication adherence monitoring technology and its development and use. The technological features, data capture methods, and potential advantages and limitations of the identified technology applications were extracted. Methods for using data for adherence monitoring were also identified. Common recurring elements were synthesized as potential technology assessment criteria.ResultsOf the 3865 articles retrieved, 98 (2.54%) were included in the final review, which reported a variety of technology applications for monitoring medication adherence, including electronic pill bottles or boxes, ingestible sensors, electronic medication management systems, blister pack technology, patient self-report technology, video-based technology, and motion sensor technology. Technical features varied by technology type, with common expectations for using these technologies to accurately monitor medication adherence and increase adoption in patients’ daily lives owing to their unobtrusiveness and convenience of use. Most technologies were able to provide real-time monitoring of medication-taking behaviors but relied on proxy measures of medication adherence. Successful implementation of these technologies in clinical settings has rarely been reported. In all, 28 technology assessment criteria were identified and organized into the following five categories: development information, technology features, adherence to data collection and management, feasibility and implementation, and acceptability and usability.ConclusionsThis narrative review summarizes the technical features, data capture methods, and various advantages and limitations of medication adherence monitoring technology reported in the literature and the proposed criteria for assessing medication adherence monitoring technologies. This collection of assessment criteria can be a useful tool to guide the development and selection of relevant technologies, facilitating the optimal adoption and effective use of technology to improve medication adherence outcomes. Future studies are needed to further validate the medication adherence monitoring technology assessment criteria and construct an appropriate technology assessment framework.

Abstract OT2-02-01: Utilization of patient reported outcomes generated by electronic medical record and smart pill bottles with follow up telehealth encounters to improve adherence to adjuvant endocrine therapy in breast cancer patients

Abstract Background: The use of adjuvant endocrine therapy (ET) in the form of tamoxifen (TAM) or an aromatase inhibitor (AI) for up to 10 years is the standard of care (SOC) for women with hormone receptor positive (HR+) breast cancer (BC). These agents can reduce recurrence by 30-50% and reduce mortality by approximately 1/3 irrespective of the use of chemotherapy (CT). Many women have difficulty with long-term compliance and persistence due to side effects and may ultimately self-discontinue. In the EBCTCG meta-analysis, evaluating 20 separate trials of adjuvant TAM for 5 years versus no adjuvant TAM, there was an estimated 80% adherence. Other BC trials have demonstrated lower adherence to TAM, dropping to 50% by years 4-5. Additionally, within the first year, discontinuation rates have been reported to be as high as 20-23%. In this investigator-initiated clinical trial we aim to evaluate the utility of one of two interventions a) serial electronic medical record (EPIC) generated patient (pt) reported outcomes (PRO)and pt surveys, OR b) a smart pill bottle, in increasing adherence to adjuvant ET over a 12-month interval during the first 4 years of adjuvant ET. The study also includes research-specific Telehealth (TH) visits when indicated in response to reports of increased toxicity or non-compliance. Methods: This is the Phase II, randomized, open-label, three-arm, multi-site study that will randomize 285 pts ≥18 years of age with stage 0-III HR+ BC in a 1:1:1 fashion with 95 patients in each arm. Arm A includes standard of care (SOC) quarterly visits (in-person or TH) with the treating provider during 12 months follow-up. Arm B is SOC quarterly visits during 12 months follow up, 18 electronic surveys every 3 weeks in between the SOC visits. Arm C is SOC quarterly visits during for 12 months follow up and use of electronic smart pill bottle with daily reminders to take ET. Primary Objective is to evaluate if the intervention of utilization of automated PROs and follow up TH encounters or the utilization of Smart Pill Bottles and follow up TH encounters can improve patient adherence with adjuvant ET within 12 months of study participation during the first 4 years of ET. The secondary objective is to evaluate if these interventions can improve quality of life and decrease side effects of adjuvant ET. The trial is open with 119 patients enrolled at the time of this abstract submission. ClinicalTrials.gov Identifier: NCT04054557 Citation Format: Utilization of patient reported outcomes generated by electronic medical record and smart pill bottles with follow up telehealth encounters to improve adherence to adjuvant endocrine therapy in breast cancer patients [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-02-01.

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.

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

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.

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...

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.

Time-of-Day Differences in Treatment-Related Habit Strength and Adherence.

BackgroundMany of our daily behaviors are habitual, occurring automatically in response to learned contextual cues, and with minimal need for cognitive and self-regulatory resources. Behavioral habit strength predicts adherence to actions, including to medications. The time of day (morning vs. evening) may influence adherence and habit strength to the degree that stability of contexts/routines varies throughout the day.PurposeThe current study evaluates whether patients are more adherent to morning versus evening doses of medication and if morning doses show evidence of greater habit strength than evening doses.MethodsObjective adherence data (exact timing of pill dosing) were collected in an observational study by electronic monitoring pill bottles in a sample of patients on twice-daily pills for Type 2 diabetes (N = 51) over the course of 1 month.ResultsData supported the hypothesis that patients would miss fewer morning than evening pills. However, counter to the hypothesis, variability in dose timing (an indicator of habit strength) was not significantly different for morning versus evening pills.ConclusionsFindings suggest that medication adherence may be greater in the morning than in the evening. However, more research is needed to evaluate the role of habitual action in this greater adherence. Furthermore, future research should evaluate the validity of behavioral timing consistency as an indicator of habit strength.

MAMBO: Measuring ambulation, motor, and behavioral outcomes with post-stroke fluoxetine in Tanzania: Protocol of a phase II clinical trial

BackgroundSSA has a high stroke incidence and post-stroke morbidity. An inexpensive pharmacological treatment for stroke recovery would be beneficial to patients in the region. Fluoxetine, currently on the World Health Organization Essential Medicines List, holds promise as a treatment for motor recovery after ischemic stroke, but its effectiveness is controversial and untested in this context in SSA. AimTo determine if fluoxetine 20 mg by mouth daily, given within 14 days of acute ischemic stroke, and taken for 90 days, is well-tolerated and safe with adequate adherence to justify a future randomized, controlled trial of fluoxetine in the United Republic of Tanzania. MethodsOpen-label, phase II clinical trial enrolling up to 120 patients. Participants will be recruited from the Muhimbili National Hospital in Dar es Salaam, Tanzania, and followed for 90 days.The primary outcomes are: 1) safety, including serum sodium and hepatic enzyme levels; and 2) tolerability, as measured through study case report forms. The secondary outcomes are: 1) change in motor strength, as measured through the Fugl-Meyer Motor Scale; 2) adherence, as measured with electronic pill bottles; and 3) participant depressive symptom burden measured via standard questionnaires. ConclusionsExpanding the evidence base for fluoxetine for Sub-Saharan African stroke survivors requires testing of its safety, tolerability, and adherence. Compared to prior studies in France and the United Kingdom, the patient characteristics, health infrastructure, and usual care for stroke recovery differ substantially in Tanzania. If fluoxetine reveals favorable endpoints, scale up of its use post-stroke is possible.

Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis

Electronic Pill Bottle Monitoring to Promote Medication Adherence for People With Multiple Sclerosis

Capsule Commentary: Mehta et al. Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence.

Capsule Commentary: Mehta et al. Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence.