A Targeted Self-Management Approach for Reducing Stroke Risk Factors in African American Men Who Have Had a Stroke or Transient Ischemic Attack.

PURPOSE: This study compared a novel self-management (TargetEd MAnageMent Intervention [TEAM]) versus treatment as usual (TAU) to reduce stroke risk in African American (AA) men. DESIGN: Six-month prospective randomized controlled trial with outcomes evaluated at baseline, 3 months, and 6 months. SETTING: Academic health center. PARTICIPANTS: Thirty-eight (age < 65) AA men who had a stroke or transient ischemic attack and a Barthel index score of >60 were randomly assigned to TEAM (n = 19) or TAU (n = 19). INTERVENTION: Self-management training, delivered in 1 individual and 4 group sessions (over 3 months). MEASURES: Blood pressure, glycosylated hemoglobin (HbA1c), lipids, medication adherence, weight, and standardized measures of health behaviors (diet, exercise, smoking, substances), depression, and quality of life. Qualitative assessments evaluated the perspectives of TEAM participants. ANALYSIS: T tests for paired differences and nonparametric tests. Thematic content qualitative analysis. RESULTS: Mean age was 52.1 (standard deviation [SD] = 7.4) and mean body mass index was 31.4 (SD = 7.4). Compared to TAU, TEAM participants had significantly lower mean systolic blood pressure by 24 weeks, and there was also improvement in HbA1c and high-density lipoprotein cholesterol ( P = .03). Other biomarker and health behaviors were similar between groups. Qualitative results suggested improved awareness of risk factors as well as positive effects of group support.

Managing information well: Toward an ontology-driven informatics platform for data sharing and secondary use in epilepsy self-management research centers.

Epilepsy is a chronic neurological condition that requires active self-management to reduce personal and population burden. The Managing Epilepsy Well Network, funded by the US Centers for Disease Control and Prevention, conducts research on epilepsy self-management. There is an urgent need to develop an integrated informatics platform to maximize the secondary use of existing Managing Epilepsy Well Network data. We have implemented multiple steps to develop an informatics platform, including: (a) a survey of existing outcome data, (b) identification of common data elements, and (c) an integrated database using an epilepsy domain ontology to reconcile data heterogeneity. The informatics platform enables assessment of epilepsy self-management samples by site and in aggregate to support data interpretations for clinical care and ongoing epilepsy self-management research. The Managing Epilepsy Well informatics platform is expected to help advance epilepsy self-management, improve health outcomes, and has potential application in other thematic research networks.

Symptom severity, self-reported adherence, and electronic pill monitoring in poorly adherent patients with bipolar disorder.

OBJECTIVES: This analysis of screening and baseline data from an ongoing trial examined self-report versus automated adherence monitoring and assessed the relationship between bipolar disorder (BD) symptoms and adherence in 104 poorly adherent individuals. METHODS: Adherence was measured with the Tablets Routine Questionnaire (TRQ) and the Medication Event Monitoring System (MEMS). Symptoms were measured with the Montgomery-Åsberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), and the Brief Psychiatric Rating Scale (BPRS). RESULTS: The mean age of the sample was 46.3 years [standard deviation (SD) = 9.41 years], with 72% (n = 75) women and 71% (n = 74) African American subjects. Adherence improved from screening to baseline, with a mean missed drug proportion measured by TRQ of 61.43% (SD = 26.48%) versus a baseline mean of 46.61% (SD = 30.55%). The mean proportion of missed medication using MEMS at baseline was 66.43% (SD = 30.40%). The correlation between TRQ and MEMS was 0.47. The correlation between a single index drug and all BD medications was 0.95. Symptoms were generally positively correlated with TRQ (worse adherence = more severe symptoms), but in most instances was only at a trend level (p > 0.05), with the exception of the correlations between baseline TRQ and MADRS and BPRS, which were positive (r = 0.20 and r = 0.21, respectively) and significant (p ≤ 0.05). CONCLUSIONS: In patients with BD, monitoring increased adherence by 15%. MEMS identified 20% more non-adherence than self-report. Using a standard procedure to identify a single index drug for adherence monitoring may be one way to assess global adherence in patients with BD receiving polypharmacy treatment. Greater BD symptom severity may be a clinical indicator to assess for adherence problems.

Comparing Patient-Reported Outcomes Measure Information System Depression Scale with Legacy Depression Measures in a Community Sample of Older Adults with Varying Levels of Cognitive Functioning.

OBJECTIVE: This study evaluated the utility of Patient-Reported Outcomes Measure Information System Depression Scale (PROMIS-8a) compared with selected "Legacy" depression scales, including the Montgomery-Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS), and GDS-Short Form (GDS-SF). Additionally, the measures' properties were assessed across levels of cognitive functioning. METHODS: This cross-sectional analysis was extracted from a prospective cohort study. PROMIS-8a and Legacy depression measures were administered to individuals aged at least 70 years grouped by cognitive status based on the Saint Louis University Mental Status Examination. McNemar tests were run to determine if measures categorized the absence or presence of depression differently and item analysis evaluated classification discrepancies. RESULTS: Sample mean age was 78, and most participants were women (71%), white (79%), with at least a high school education (89%). The percentage of individuals with at least mild depression was similar across measures (20.7% PROMIS-8a, 19.0% MADRS, 17.9% GDS, 13.9% GDS-SF). PROMIS-8a total score correlated moderately with MADRS (r = 0.56, df = 295, p <0.01), GDS (r = 0.68, df = 291, p <0.01), and GDS-SF (r = 0.60, df = 291, p <0.01), and predictive validity of the measures was similar. There were no significant mean differences on depression measures by cognitive status. CONCLUSION: Although all measures identified a similar percent of depressed individuals, the classification differed by measure. Item analysis showed that PROMIS-8a was more likely to identify feelings of dysphoria while the MADRS and GDS were more likely to identify physiologic aspects of depression. Given the brevity and ease of administration of the PROMIS-8a, it appears to be a useful depression screen for community-dwelling older adults.

Use of automated medication adherence monitoring in bipolar disorder research: pitfalls, pragmatics, and possibilities.

OBJECTIVES: Medication nonadherence occurs in 20-60% of persons with bipolar disorder (BD) and is associated with serious negative outcomes, including relapse, hospitalization, incarceration, suicide and high healthcare costs. Various strategies have been developed to measure adherence in BD. This descriptive paper summarizes challenges and workable strategies using electronic medication monitoring in a randomized clinical trial (RCT) in patients with BD. METHODS: Descriptive data from 57 nonadherent individuals with BD enrolled in a prospective RCT evaluating a novel customized adherence intervention versus control were analyzed. Analyses focused on whole group data and did not assess intervention effects. Adherence was assessed with the self-reported Tablets Routine Questionnaire and the Medication Event Monitoring System (MEMS). RESULTS: The majority of participants were women (74%), African American (69%), with type I BD (77%). Practical limitations of MEMS included misuse in conjunction with pill minders, polypharmacy, cost, failure to bring to research visits, losing the device, and the device impacting baseline measurement. The advantages were more precise measurement, less biased recall, and collecting data from past time periods for missed interim visits. CONCLUSIONS: Automated devices such as MEMS can assist investigators in evaluating adherence in patients with BD. Knowing the anticipated pitfalls allows study teams to implement preemptive procedures for successful implementation in BD adherence studies and can help pave the way for future refinements as automated adherence assessment technologies become more sophisticated and readily available.

A technology-enabled adherence enhancement system for people with bipolar disorder: results from a feasibility and patient acceptance analysis.

OBJECTIVE: As poor medication adherence is common in bipolar disorder (BD), technology-assisted approaches may help to monitor and enhance adherence. This study evaluated preliminary feasibility, patient satisfaction and effects on adherence, BD knowledge, and BD symptoms associated with the use of a multicomponent technology-assisted adherence enhancement system. METHODS: This prospective study tested the system in five BD patients over a 15-day period. System components included: 1) an automated pill cap with remote monitoring sensor; 2) a multimedia adherence enhancement program; and 3) a treatment incentive program. This study evaluated system usability, patient satisfaction and effects on adherence (Morisky scale), knowledge (treatment knowledge test [TKT]), and symptoms (internal state scale [ISS]). RESULTS: Mean age of the sample was 62 years, 4/5 (80%) Caucasian, and 4/5 (80%) single/divorced or widowed. Most participants (4/5, 80%) were on a single BD medication. Participants had BD for an average of 21 years. Challenges included attaching the pill sensor to standard pharmacy bottles for individuals using very large pill containers or those with multiday pill boxes. Three of five (60%) individuals completed the full 15-day period. Usability scores were high overall. Mean Morisky scores improved. Means on all four subscales of the ISS were all in the direction of improvement. On the TKT, there was a 40% increase in mean scores. CONCLUSION: A multicomponent technology-assisted BD adherence enhancement system is feasible. Challenges include accommodating multiple types of pill containers and monitoring multiple drugs simultaneously. The system can also generate adherence information that is potentially useful for treatment planning.

Comparison of common data elements from the Managing Epilepsy Well (MEW) Network integrated database and a well-characterized sample with nonepileptic seizures.

INTRODUCTION: Epilepsy and psychogenic nonepileptic seizures (PNES) are both chronic illnesses characterized by similar and overlapping clinical features. A limited number of studies comparing people with epilepsy (PWE) and patients with PNES that address determinants of health outcomes exist. We conducted an analysis using a well-characterized sample of people with PNES and the Managing Epilepsy Well (MEW) Network integrated data, comparing descriptive data on samples with epilepsy and with documented PNES. Based on the pooled data, we hypothesized that people with PNES would have worse QOL and higher depression severity than PWE. MATERIAL AND METHODS: We used data from the MEW Network integrated database involving select epilepsy self-management studies comprising 182 PWE and 305 individuals with documented PNES from the Rhode Island Hospital Neuropsychiatry and Behavioral Neurology Clinic. We conducted a matched, case-control study assessing descriptive comparisons on 16 common data elements that included gender, age, ethnicity, race, education, employment, income, household composition, relationship status, age at seizure onset, frequency of seizures, seizure type, health status, healthy days, quality of life, and depression. Standardized rating scales for depression and quality of life were used. RESULTS: Median seizure frequency in the last 30days for PWE was 1, compared to 15 for patients with PNES (p<0.05). People with epilepsy had a QOLIE-10 mean score of 3.00 (SD: 0.91) compared to 3.54 (0.88) (p<0.01) for patients with PNES. Depression severity was moderate to severe in 7.7% of PWE compared to 34.1% (p<0.05) of patients with PNES. DISCUSSION: People with epilepsy in selected MEW Network programs are fairly well educated, mostly women, with few minorities and low monthly seizure rates. Those with PNES, however, have higher levels of not working/on disability and had more frequent seizures, higher depression severity, and worse QOL. These differences were present despite demographics that are largely similar in both groups, illustrating that other determinants of illness may influence PNES.

Asenapine in the treatment of older adults with bipolar disorder.

OBJECTIVE: In spite of growing numbers of older people, there are few treatment studies on late-life bipolar disorder (BD). This was a 12-week prospective, open-label trial to assess efficacy and tolerability of adjunct asenapine in non-demented older adults (≥ 60 years) with sub-optimal previous response to BD treatments. METHODS: Asenapine was initiated at 5 mg/day and titrated as tolerated. Effects on global psychopathology were measured with Clinical Global Impression, bipolar version (CGI-BP), and the Brief Psychiatric Rating Scale (BPRS). Mood polarity severity was measured with the Hamilton Depression Rating Scale, Montgomery Asberg Depression Rating Scale, and Young Mania Rating Scale. Other outcomes included the World Health Organization Disability Assessment Schedule II. RESULTS: Fifteen individuals were enrolled (mean age 68.6, SD 6.12; 53% female; 73% Caucasian, 13% African American, and 7% Asian). There were 4/15 (27%) individuals who prematurely terminated the study, whereas 11/15 (73%) completed the study. There were significant improvements from baseline on the BPRS (p < 0.05), on CGI-BP overall (p < 0.01), and on CGI-BP mania (p < 0.05) and depression (p < 0.01) subscales. The mean dose of asenapine was 11.2 (SD 6.2) mg/day. The most common reported side effects were gastrointestinal discomfort (n = 5, 33%), restlessness (n = 2, 13%), tremors (n = 2, 13%), cognitive difficulties (n = 2, 13%), and sluggishness (n = 2, 13%). CONCLUSIONS: Older people with BD had global improvements on asenapine. Most reported adverse effects were mild and transient, but adverse effects prompted drug discontinuation in just over one quarter of patients. Although risks versus benefits in older people must always be carefully considered, asenapine may be a treatment consideration for some non-demented geriatric BD patients.

Comparing medication attitudes and reasons for medication nonadherence among three disparate groups of individuals with serious mental illness.

This analysis compared medication attitudes and reasons for nonadherence in three distinct groups of patients with serious mental illness (SMI). Cohort 1 had 43 patients with bipolar disorder (BD) treated in a community mental health setting, cohort 2 had 43 patients with BD taking an atypical antipsychotic and treated in an academic medical center, and cohort 3 had 30 patients with schizophrenia or schizoaffective disorder who had been homeless in the last year. Standardized attitudinal scales found generally negative attitudes toward medication and limited illness insight. Although the three cohorts differed with regard to severity of symptoms, age of onset, education, baseline adherence, and race, the groups had similar medication attitudes before and after treatment. Despite group differences in demographic and clinical variables, our analyses found more similarities than differences in medication attitudes among these three discrete groups of poorly adherent, symptomatic patients with SMI. The common attitudinal characteristics have implications for delivery of health care services that can enhance treatment adherence in high-risk SMI patients.