Electronic Pill Cap Research Articles

Parental Depression and Pancreatic Enzymes Adherence in Children With Cystic Fibrosis.

Treatment adherence in cystic fibrosis (CF) is often poor, however, less is known about adherence to pancreatic enzymes, a critical component of the CF treatment regimen. Parent caregivers often report elevations in depression, and parental depression may adversely affect children's adherence. This prospective study evaluated adherence to pancreatic enzymes in 83 patients (1-13 years) . Adherence was measured across 3 months with electronic pill-caps . Weight was measured at baseline and a 3-month follow-up. Parental depressive symptoms were evaluated by using the Center for Epidemiologic Studies Depression Scale (CES-D). Adherence to pancreatic enzymes was 49.4% ± 3.4%. Adherence was higher at school (94.4% ± 6.1%) than at home (42.3% ± 3.1%), and higher for toddlers (50.6% ± 5.2%) than for school-aged children (37.5% ± 3.7%). Parents reported high rates of depressive symptoms (30% in the clinical range, 18% with moderate symptoms). Children of parents with symptoms of depression versus those without were less adherent (34.8% ± 4.5% vs 48.5% ± 4.1%), and adherence to enzymes was significantly related to 3-month weight outcomes. Average gain in weight z scores across 3 months was 0.5 ± 0.2for children who were >50% adherent and -0.1 ± 6.1for children who were <33% adherent. Parental depression had a signifcant, indirect effect on weight via adherence (-0.005 ± 0.003 gain in weight z score per CES-D unit ). High rates of parental depressive symptoms, coupled with its negative effects on adherence, suggest that measuring and treating parental depression may improve children's adherence to therapy.

Self-Efficacy and Adherence to Antiviral Treatment for Chronic Hepatitis C

To investigate the role of self-efficacy (SE) during hepatitis C virus (HCV) treatment. Adherence to chronic HCV treatment is critical. SE is an important predictor of medication adherence in a number of chronic disease populations and medication regimens, but its role during HCV treatment remains unknown. Data from the prospective Virahep-C study were analyzed to examine relationships between SE and patient-driven deviations (ie, missed doses measured using electronic pill caps, and nonpersistence) from adherence to HCV antiviral treatment. SE was measured using the 17-item HCV Treatment Self-Efficacy scale. This measure provides a global estimate of a patient's confidence to undergo and adhere to HCV treatment, and can estimate SE in 4 underlying domains: communication SE (ie, confidence to communicate with health care provider), physical coping SE (ie, confidence to cope with physical side effects), psychological coping SE (ie, confidence to cope with psychiatric side effects), and treatment adherence SE (ie, confidence to take all medications as prescribed and attend doctor visits). Generalized estimating equations and Cox proportional hazards models were used to assess associations between SE and missed doses and nonpersistence, respectively. SE was associated with being in a relationship, educated, privately insured, and less depressed. Higher communication SE at TW24 reduced the risk of missed doses between TW24 and TW48. Higher baseline treatment adherence SE reduced the likelihood of nonpersistence between baseline and TW24. SE's relationship to HCV treatment adherence has promising clinical and research implications.

Changes in neurocognition and adherence over six months in HIV-infected individuals with cocaine or heroin dependence

We sought to examine the course of adherence and cognition in HIV-infected individuals with either cocaine or heroin dependence and investigate independent predictors of cognition change. A prospective study over six months was undertaken in which adherence was measured by monthly electronic pill cap monitoring (Medication Event Monitoring System), while a comprehensive neuropsychological battery resulting in a composite score (NPZ8) was performed at baseline and six months. Multivariable regression models were performed in order to determine independent associations with change in cognition. There were 101 subjects at baseline, of whom 62% were male and 83% were non-Hispanic black. 46.6% of subjects at baseline had completed high school, 36.6% reported active cocaine use during the course of the study, and 0% reported active heroin use during the course of the study. 66 subjects completed the final cognitive assessment at six months. Subjects had markedly impaired cognitive function at baseline (NPZ8 –1.49) which persisted at six months (NPZ8 –1.47) in the group of study completers. There was an average monthly decrease in adherence of –2.91% overall (p = 0.008). In the multivariable model, each of the following variables: baseline cognition (R2 change = 0.121, p = 0.006), cocaine use during the study (R2 change = 0.059, p = 0.046), and monthly adherence change (R2 change = 0.078, p = 0.018) independently contributed to NPZ8 change with an overall R2 change = 0.219 (p = 0.001). This study shows an overall decrease in adherence over time in this population of subjects with a history of drug dependence. Active cocaine use, baseline cognition, and temporal adherence changes independently contributed to changes in cognition. Further study on enhancing adherence, cognition, and limiting drug abuse are warranted in this subgroup of HIV-infected individuals.

Congestive heart failure adherence redesign trial: a pilot study

ObjectiveHeart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of...

Psychosocial Syndemics are Additively Associated with Worse ART Adherence in HIV-Infected Individuals.

Adherence to antiretroviral therapy (ART) among HIV-infected individuals is necessary to both individual and public health, and psychosocial problems have independently been associated with poor adherence. To date, studies have not systematically examined the effect of multiple, co-occurring psychosocial problems (i.e., "syndemics") on ART adherence. Participants included 333 HIV-infected individuals who completed a comprehensive baseline evaluation, as part of a clinical trial to evaluate an intervention to treat depression and optimize medication adherence. Participants completed self-report questionnaires, and trained clinicians completed semi-structured diagnostic interviews. ART non-adherence was objectively measured via an electronic pill cap (i.e., MEMS). As individuals reported a greater number of syndemic indicators, their odds of non-adherence increased. Co-occurring psychosocial problems have an additive effect on the risk for poor ART adherence. Future behavioral medicine interventions are needed that address these problems comprehensively, and/or the core mechanisms that they share.

P4.100 Measuring Adherence to Antiretroviral Therapy in Northern Tanzania: Feasibility and Acceptability of the Medication Event Monitoring System

BackgroundAn often-used tool to measure adherence to antiretroviral therapy (ART) is the Medication Event Monitoring System (MEMS), an electronic pill-cap that registers date and time of pill-bottle openings. Despite its...

Test of a Web-Based Program to Improve Adherence to HIV Medications

We evaluated the effectiveness of a web-based version of the Life-Steps intervention combined with modules for stress reduction and mood management, designed to improve medication adherence among HIV infected individuals. 168 HIV+ adults were randomized into either the Life-Steps program or a waitlist control condition. All participants completed a baseline assessment and provided a 2-week electronic pill (MEMS) cap baseline reading. Follow up data collection was conducted at 3, 6 and 9 months. Patients in the web-based Life-Steps condition had significantly higher antiretroviral medication adherence rates than patients in the control group over the nine-month period as measured by the MEMS cap. In addition, analysis of viral load data indicated that the program also resulted in a significant decrease in viral load. These findings indicate that a web-based Life-Steps program can be a useful and implementable tool for helping patients living with HIV maintain medication adherence.

Cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected injection drug users: A randomized controlled trial.

Depression and substance use, the most common comorbidities with HIV, are both associated with poor treatment adherence. Injection drug users comprise a substantial portion of individuals with HIV in the United States and globally. The present study tested cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with HIV and depression in active substance abuse treatment for injection drug use. This is a 2-arm, randomized controlled trial (N = 89) comparing CBT-AD with enhanced treatment as usual (ETAU). Analyses were conducted for two time-frames: (a) baseline to post-treatment and (b) post-treatment to follow-up at 3 and 6 months after intervention discontinuation. At post-treatment, the CBT-AD condition showed significantly greater improvement than ETAU in MEMS (electronic pill cap) based adherence, γslope = 0.8873, t(86) = 2.38, p = .02; dGMA-raw = 0.64, and depression, assessed by blinded assessor: Mongomery-Asberg Depression Rating Scale, F(1, 79) = 6.52, p < .01, d = 0.55; clinical global impression, F(1, 79) = 14.77, p < .001, d = 0.85. After treatment discontinuation, depression gains were maintained, but adherence gains were not. Viral load did not differ across condition; however, the CBT-AD condition had significant improvements in CD4 cell counts over time compared with ETAU, γslope = 2.09, t(76) = 2.20, p = .03, dGMA-raw = 0.60. In patients managing multiple challenges including HIV, depression, substance dependence, and adherence, CBT-AD is a useful way to integrate treatment of depression with an adherence intervention. Continued adherence counseling is likely needed, however, to maintain or augment adherence gains in this population.

Effects of Depression and Anxiety Improvement on Adherence to Medication and Health Behaviors in Recently Hospitalized Cardiac Patients

Impaired adherence to medications and health behaviors may mediate the connection between psychiatric symptoms and mortality in cardiac patients. This study assessed the association between improvements in depression/anxiety and self-reported adherence to health behaviors in depressed cardiac patients in the 6 months after cardiac hospitalization. Data were analyzed from depressed patients on inpatient cardiac units who were hospitalized for acute coronary syndrome, heart failure, or arrhythmia and enrolled in a randomized trial of collaborative care depression management (n = 134 in primary analysis). Measurements of depression (Patient Health Questionnaire-9), anxiety (Hospital Anxiety and Depression Scale, Anxiety subscale), and adherence to secondary prevention behaviors (Medical Outcomes Study-Specific Adherence Scale items) were obtained at baseline, 6 weeks 12 weeks, and 6 months. The association between improvement in depression/anxiety and adherence was assessed by linear regression after accounting for the effects of multiple relevant covariates. At all time points improvement in the Patient Health Questionnaire-9 was significantly and independently associated with self-reported adherence to medications and secondary prevention behaviors. In contrast, improvement in the Hospital Anxiety and Depression Scale, Anxiety subscale was associated with improved adherence only at 6 weeks. In conclusion, in a cohort of depressed cardiac patients, improvement in depression was consistently and independently associated with superior self-reported adherence to medications and secondary prevention behaviors across a 6-month span, whereas improvement in anxiety was not.

Measuring adherence to antiretroviral therapy in northern Tanzania: feasibility and acceptability of the Medication Event Monitoring System

BackgroundAn often-used tool to measure adherence to antiretroviral therapy (ART) is the Medication Event Monitoring System (MEMS), an electronic pill-cap that registers date and time of pill-bottle openings. Despite its strengths, MEMS-data can be compromised by inaccurate use and acceptability problems due to its design. These barriers remain, however, to be investigated in resource-limited settings. We evaluated the feasibility and acceptability of using MEMS-caps to monitor adherence among HIV-infected patients attending a rural clinic in Tanzania's Kilimanjaro Region.MethodsEligible patients were approached and asked to use the MEMS-caps for three consecutive months. Thereafter, qualitative, in-depth interviews about the use of MEMS were conducted with the patients. MEMS-data were used to corroborate the interview results.ResultsTwenty-three of the 24 patients approached agreed to participate. Apart from MEMS-use on travel occasions, patients reported no barriers regarding MEMS-use. Unexpectedly, the MEMS-bottle design reduced the patients' fear for HIV-status disclosure. Patients indicated that having their behavior monitored motivated them to adhere better. MEMS-data showed that most patients had high levels of adherence and there were no bottle-openings that could not be accounted for by medication intake. Non-adherence in the days prior to clinic visits was common and due to the clinic dispensing too few pills.ConclusionMEMS-bottle use was readily accepted by patients. Although the MEMS-bottle was used accurately by most patients, patients need to be more explicitly instructed to continue MEMS-use when travelling. Even HIV-clinics with sufficient staff and free medication may impose structural adherence barriers by supplying an insufficient amount of pills.

Can We Predict Daily Adherence to Warfarin?: Results From the International Normalized Ratio Adherence and Genetics (IN-RANGE) Study

Warfarin is the primary therapy to prevent stroke and venous thromboembolism. Significant periods of nonadherence frequently go unreported by patients and undetected by providers. Currently, no comprehensive screening tool exists to help providers assess the risk of nonadherence at the time of initiation of warfarin therapy.This article reports on a prospective cohort study of adults initiating warfarin therapy at two anticoagulation clinics (university- and Veterans Affairs-affiliated). Nonadherence, defined by failure to record a correct daily pill bottle opening, was measured daily by electronic pill cap monitoring. A multivariable logistic regression model was used to develop a point system to predict daily nonadherence to warfarin.We followed 114 subjects for a median of 141 days. Median nonadherence of the participants was 14.4% (interquartile range [IQR], 5.8-33.8). A point system, based on nine demographic, clinical, and psychosocial factors, distinguished those demonstrating low vs high levels of nonadherence: four points or fewer, median nonadherence 5.8% (IQR, 2.3-14.1); five points, 9.1% (IQR, 5.9-28.6); six points, 14.5% (IQR, 7.1-24.1); seven points, 14.7% (IQR, 7.0-34.7); and eight points or more, 29.3% (IQR, 15.5-41.9). The model produces a c-statistic of 0.66 (95% CI, 0.61-0.71), suggesting modest discriminating ability to predict day-level warfarin nonadherence.Poor adherence to warfarin is common. A screening tool based on nine demographic, clinical, and psychosocial factors, if further validated in other patient populations, may help to identify groups of patients at lower risk for nonadherence so that intensified efforts at increased monitoring and intervention can be focused on higher-risk patients.

The impact of neuropsychological functioning on adherence to HAART in HIV-infected substance abuse patients.

This study assessed the frequency of neuropsychological impairment and its relationship to adherence in a sample of HIV-infected injection drug users (IDUs) in treatment. One hundred eight participants recruited between September 2006 and October 2008 completed psychodiagnostic and neuropsychological assessments and monitored HAART adherence over a 2-week period via the use of Medication Event Monitoring System (MEMS) electronic pill caps and self-report. Assessment of concurrent functioning included clinician-rated scales of depression and substance use severity, and a battery of neuropsychological tests. Findings from individual neuropsychological tests were converted to Z scores relative to standard norms and averaged to form a composite score (NPZ). NPZ was generally poor (mean = -1.505, standard deviation = 1.120), with 76.9% of the sample being classified as highly impaired. Self-reported adherence was significantly higher than MEMS cap adherence. In contrast with previous studies, overall neuropsychological functioning was not a significant predictor of electronically monitored or self-reported adherence. However, examiner-rated current global severity of substance use and delayed word list recall emerged as significant predictors of self-reported adherence. Additionally, estimated premorbid verbal intelligence emerged as a significant predictor of the discrepancy between electronically monitored and self-reported adherence. Given the extent of neuropsychological impairment in this sample, future studies should examine the degree to which the impact of neuropsychological impairment may moderate interventions for this population, and the extent to which skills to cope with neuropsychological problems may boost the potential efficacy of such interventions.

Adherence to Warfarin Assessed by Electronic Pill Caps, Clinician Assessment, and Patient Reports: Results from the IN-RANGE Study

Patient adherence to warfarin may influence anticoagulation control; yet, adherence among warfarin users has not been rigorously studied. Our goal was to quantify warfarin adherence over time and to compare electronic medication event monitoring systems (MEMS) cap measurements with both self-report and clinician assessment of patient adherence. We performed a prospective cohort study of warfarin users at 3 Pennsylvania-based anticoagulation clinics and assessed pill-taking behaviors using MEMS caps, patient reports, and clinician assessments. Among 145 participants, the mean percent of days of nonadherence by MEMS was 21.8% (standard deviation+/-21.1%). Participants were about 6 times more likely to take too few pills than to take extra pills (18.8 vs. 3.3%). Adherence changed over time, initially worsening over the first 6 months of monitoring, which was followed by improvement beyond 6 months. Although clinicians were statistically better than chance at correctly labeling a participant's adherence (odds ratio = 2.05, p = 0.015), their estimates often did not correlate with MEMS-cap data; clinicians judged participants to be "adherent" at 82.8% of visits that were categorized as moderately nonadherent using MEMS-cap data (>or=20% nonadherence days). Similarly, at visits when participants were moderately nonadherent by MEMS, they self-reported perfect adherence 77.9% of the time. These results suggest that patients may benefit from adherence counseling even when they claim to be taking their warfarin or the clinician feels they are doing so, particularly several months into their course of therapy.

Perceptions About the Acceptability of Assessments of HIV Medication Adherence in Lilongwe, Malawi and Chennai, India

Little research exists on acceptability issues related to assessments of adherence to ART in resource-poor settings. To help prepare for two large-scale, multisite ART intervention trials, this qualitative study of individuals in Chennai, India (49 men, 11 women; 33 taking ART, 27 not) and Lilongwe, Malawi (5 men, 5 women, all taking ART) examined potential limitations of different types of adherence assessments: an adherence questionnaire, a pill diary, a pillbox, an electronic pill cap, and a medication punch card. Many participants reported that the various assessments would be acceptable. Potential limitations included issues surrounding literacy, the desire to appease one's medical provider, privacy and stigma, and "cheating." These potential limitations are similar to the limitations of these assessments in Western settings. However, the data highlight the need to consider individual patient level concerns when assessing ART adherence in different cultural settings. Innovative ways of monitoring adherence while maintaining standardization across sites are required in multisite trials.

Use of an on-line pager system to increase adherence to antiretroviral medications

Adherence to antiretroviral therapy is critical for treatment success. Antiretroviral therapy typically requires multiple pills at multiple dosing times. To address this, we tested the feasibility, utility, and efficacy of a customizable reminder system using pagers, which were programmed using web-based technology, to increase and maintain proper adherence in patients with pre-existing adherence problems. After a two-week monitoring period with an electronic pill-cap, participants with less than 90% adherence were randomized to continue monitoring or to receive a pager. The group who received the pagers had greater improvements in adherence from baseline to Week 2 and Week 12 than those who monitored their medications only. However, adherence in both groups at the outcome assessments points was still poor. While the provision of a reminder system helped improve adherence, it is likely that more intensive interventions are required for patients with pre-existing problems.