Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial.

BACKGROUND: Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi. METHODS: In a 2-armed randomized controlled trial, a provider-supported self-help CBTi (Tele-Self CBTi) is compared to Health Education for improving insomnia severity (primary outcome) among treatment-seeking veterans with insomnia disorder. Tele-Self CBTi is comprised of two treatment components: self-help CBTi via a professionally designed manual developed using an iterative process of expert review and patient input; and 6 telephone-based support sessions lasting >20 min. Outcomes are assessed at baseline, 8 weeks, and 6 months after baseline. The primary outcome, insomnia severity, is measured using the Insomnia Severity Index. Secondary outcomes include self-reported and actigraphy-assessed sleep, fatigue, depression symptoms, and sleep-related quality of life. CONCLUSION: Innovative approaches are essential to improving overall health among veterans; a population with highly prevalent insomnia disorder. If effective, Tele-Self CBTi may bridge the gap between unavailable resources and high demand for CBTi and serve as the entry level intervention in a stepped model of care. GOV IDENTIFIER: NCT03727438.

Video-Enhanced Care Management for Medically Complex Older Adults with Cognitive Impairment.

OBJECTIVE: This pilot study assessed feasibility of video-enhanced care management for complex older veterans with suspected mild cognitive impairment (CI) and their care partners, compared with telephone delivery. DESIGN: Pilot randomized controlled trial. SETTING: Durham Veterans Affairs Health Care System. PARTICIPANTS: Participants were enrolled as dyads, consisting of veterans aged 65 years or older with complex medical conditions (Care Assessment Need score ≥90) and suspected mild CI (education-adjusted Modified Telephone Interview for Cognitive Status score 20-31) and their care partners. INTERVENTION: The 12-week care management intervention consisted of monthly calls from a study nurse covering medication management, cardiovascular disease risk reduction, physical activity, and sleep behaviors, delivered via video compared with telephone. MEASUREMENTS: Dyads completed baseline and follow-up assessments to assess feasibility, acceptability, and usability. RESULTS: Forty veterans (mean (standard deviation (SD)) age = 72.4 (6.1) years; 100% male; 37.5% Black) and their care partners (mean (SD) age = 64.7 (10.8) years) were enrolled and randomized to telephone or video-enhanced care management. About a third of veteran participants indicated familiarity with relevant technology (regular tablet use and/or experience with videoconferencing); 53.6% of internet users were comfortable or very comfortable using the internet. Overall, 43 (71.7%) care management calls were completed in the video arm and 52 (86.7%) were completed in the telephone arm. Usability of the video telehealth platform was rated higher for participants already familiar with technology used to deliver the intervention (mean (SD) System Usability Scale scores: 65.0 (17.0) vs 55.6 (19.6)). Veterans, care partners, and study nurses reported greater engagement, communication, and interaction in the video arm. CONCLUSION: Video-delivered care management calls were feasible and preferred over telephone for some complex older adults with mild CI and their care partners. Future research should focus on understanding how to assess and incorporate patient and family preferences related to uptake and maintenance of video telehealth interventions.

Measuring Sustained Attention and Perceived Workload.

OBJECTIVE: We examined the effects of spatial uncertainty, field dependence/independence (FD/I), and sex on vigilance performance and perceived workload in elementary school children. BACKGROUND: Building on previous work in which children demonstrated their ability to evaluate workload, we tested whether spatial-uncertainty manipulations in a vigilance task would elicit in children the same deleterious effects on performance and workload as it does with adults. We also examined individual difference effects associated with FD/I and sex to determine their influence on both performance and workload. METHOD: In the low-uncertainty task, stimuli appeared in the center of the computer screen; in the high-uncertainty task, they appeared in one of the four quadrants of the screen. Neutral events consisted of uppercase letter strings. Critical signals consisted of a single lowercase letter among uppercase letters. Following each vigil, children completed a workload assessment via a modified version of the NASA Task Load Index. RESULTS: Children showed lower perceptual sensitivity, greater response latency variability (RTSD), and a higher response criterion in the uncertain display condition. Workload scores reflected these performance differences. Field-dependent children showed lower perceptual sensitivity and greater RTSD than did field-independent children. The two groups exhibited differing workload profiles. Despite no objective performance differences, boys reported greater workload than girls. CONCLUSION: The scale demonstrated sensitivity and diagnosticity with regard to both the task variable and individual differences. APPLICATION: These findings contribute to the emerging field of "educational ergonomics" and indicate that appropriate assessment tools might identify children who are experiencing increased workload.

Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.

Effects of Memory Load and Test Position on Short-Duration Sustained Attention Tasks.

The current study applies a dual-task working memory and vigilance task to examine sustained attention performance and perceived workload in a multi-instrument battery. In Experiment 1 we modified a task developed by Helton and Russell (2011) to examine declines in performance and to assess the effects of its position within a larger battery. Experiment 1 failed to reveal a sensitivity decrement, and test position revealed only spurious influence. Workload scores derived from the NASA-TLX fell at the high end of the scale, with mental and temporal demand receiving the highest ratings. In Experiment 2, we modified the dual task to place more emphasis on attention rather than working memory. Results revealed a significant decline in performance across the vigil for the perceptual sensitivity index A'. Test position (early vs. late) effects appeared with the reaction time variability measure, with performance becoming more variable when the task appeared in the latter half of the battery. Workload scores varied according to position in the battery: Workload scores were higher when the vigilance task appeared in the latter half of the battery. Practical and theoretical implications are discussed.

Measuring perceived mental workload in children.

Little is known about the mental workload, or psychological costs, associated with information processing tasks in children. We adapted the highly regarded NASA Task Load Index (NASA-TLX) multidimensional workload scale (Hart & Staveland, 1988) to test its efficacy for use with elementary school children. We developed 2 types of tasks, each with 2 levels of demand, to draw differentially on resources from the separate subscales of workload. In Experiment 1, our participants were both typical and school-labeled gifted children recruited from 4th and 5th grades. Results revealed that task type elicited different workload profiles, and task demand directly affected the children's experience of workload. In general, gifted children experienced less workload than typical children. Objective response time and accuracy measures provide evidence for the criterion validity of the workload ratings. In Experiment 2, we applied the same method with 1st- and 2nd-grade children. Findings from Experiment 2 paralleled those of Experiment 1 and support the use of NASA-TLX with even the youngest elementary school children. These findings contribute to the fledgling field of educational ergonomics and attest to the innovative application of workload research. Such research may optimize instructional techniques and identify children at risk for experiencing overload.

The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes.

BACKGROUND: Cardiovascular disease (CVD) and diabetes account for one-third of the mortality difference between African American and white patients. We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes. METHODS: We randomized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention. The 12-month intervention provided monthly self-management support and quarterly medication management facilitation. Coprimary outcomes were changes in systolic blood pressure (SBP), hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C) over 12 months. We estimated between-intervention group differences over time using linear mixed-effects models. The secondary outcome was self-reported medication adherence. RESULTS: The sample was 72% female; 49% had low health literacy, and 37% had annual income <$10,000. Model-based estimates for mean baseline SBP, HbA1c, and LDL-C were 136.8 mm Hg (95% CI 135.0-138.6), 8.0% (95% CI 7.8-8.2), and 99.1 mg/dL (95% CI 94.7-103.5), respectively. Intervention patients received 9.9 (SD 3.0) intervention calls on average. Primary providers replied to 76% of nurse medication management facilitation contacts, 18% of these resulted in medication changes. There were no between-group differences over time for SBP (P = .11), HbA1c (P = .66), or LDL-C (P = .79). Intervention patients were more likely than those receiving usual care to report improved medication adherence (odds ratio 4.4, 95% CI 1.8-10.6, P = .0008), but adherent patients did not exhibit relative improvement in primary outcomes. CONCLUSIONS: This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes. Further research is needed to determine how to maximally impact CVD risk factors in African American patients.

Home blood pressure management and improved blood pressure control: results from a randomized controlled trial.

BACKGROUND: To determine which of 3 interventions was most effective in improving blood pressure (BP) control, we performed a 4-arm randomized trial with 18-month follow-up at the primary care clinics at a Veterans Affairs Medical Center. METHODS: Eligible patients were randomized to either usual care or 1 of 3 telephone-based intervention groups: (1) nurse-administered behavioral management, (2) nurse- and physician-administered medication management, or (3) a combination of both. Of the 1551 eligible patients, 593 individuals were randomized; 48% were African American. The intervention telephone calls were triggered based on home BP values transmitted via telemonitoring devices. Behavioral management involved promotion of health behaviors. Medication management involved adjustment of medications by a study physician and nurse based on hypertension treatment guidelines. RESULTS: The primary outcome was change in BP control measured at 6-month intervals over 18 months. Both the behavioral management and medication management alone showed significant improvements at 12 months-12.8% (95% confidence interval [CI], 1.6%-24.1%) and 12.5% (95% CI, 1.3%-23.6%), respectively-but not at 18 months. In subgroup analyses, among those with poor baseline BP control, systolic BP decreased in the combined intervention group by 14.8 mm Hg (95% CI, -21.8 to -7.8 mm Hg) at 12 months and 8.0 mm Hg (95% CI, -15.5 to -0.5 mm Hg) at 18 months, relative to usual care. CONCLUSIONS: Overall intervention effects were moderate, but among individuals with poor BP control at baseline, the effects were larger. This study indicates the importance of identifying individuals most likely to benefit from potentially resource intensive programs. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00237692.

The Cholesterol, Hypertension, and Glucose Education (CHANGE) study for African Americans with diabetes: study design and methodology.

BACKGROUND: Cardiovascular disease (CVD) and diabetes account for over one third of the mortality difference between African Americans and white patients. The increased CVD risk in African Americans is due in large part to the clustering of multiple CVD risk factors. OBJECTIVES: The current study is aimed at improving CVD outcomes in African-American adults with diabetes by addressing the modifiable risk factors of systolic blood pressure , glycosylated hemoglobin, and low-density lipoprotein cholesterol. METHODS: A sample of African American patients with diabetes (N = 400) will receive written education material at baseline and be randomized to one of 2 arms: (1) usual primary care or (2) nurse-administered disease-management intervention combining patient self-management support and provider medication management. The nurse administered intervention is delivered monthly over the telephone. The nurses also interacts with the primary care providers at 3, 6, and 9 months to provide concise patient updates and facilitate changes in medical management. All patients are followed for 12 months after enrollment. The primary outcomes are change in glycosylated hemoglobin, systolic blood pressure, and low-density lipoprotein cholesterol over 12-months. Secondary outcomes include change in overall cardiovascular risk, aspirin use, and health behaviors. CONCLUSION: Given the continued racial disparities in CVD, the proposed study could result in significant contributions to cardiovascular risk reduction in African-American patients.

Hypertension Intervention Nurse Telemedicine Study (HINTS): testing a multifactorial tailored behavioral/educational and a medication management intervention for blood pressure control.

BACKGROUND: Only 31% of Americans with hypertension have their blood pressure (BP) under effective control. We describe a study that tests 3 different interventions in a randomized controlled trial using home BP telemedicine monitoring. METHODS: A sample of hypertensive patients with poor BP control at baseline (N = 600) are randomized to 1 of 4 arms: (1) control group--a group of hypertensive patients who receive usual care; (2) nurse-administered tailored behavioral intervention; (3) nurse-administered medication management according to a hypertension decision support system; (4) combination of the 2 interventions. The interventions are triggered based on home BP values transmitted via telemonitoring devices over standard telephone lines. The tailored behavioral intervention involves promoting adherence with medication and health behaviors. Patients randomized to the medication management or the combined arm have their hypertension regimen changed by the study team using a validated hypertension decision support system based on evidence-based hypertension treatment guidelines and individualized to patients' comorbid illnesses. The primary outcome is BP control: < or = 140/90 mm Hg (nondiabetic) and < or = 130/80 mm Hg (diabetics) measured at 6-month intervals over 18 months (4 total measurements). CONCLUSIONS: Given the increasing prevalence of hypertension and our inability to achieve adequate BP control using traditional models of care, testing novel interventions in patients' homes may improve access, quality, and outcomes.

Predicting poor outcome from acute upper gastrointestinal hemorrhage.

BACKGROUND: Uncertainty about the outcome of acute upper gastrointestinal bleeding often results in a longer-than-necessary hospital stay. METHODS: We derived and internally validated clinical prediction rules (CPRs) to predict outcome from upper gastrointestinal bleeding. This multisite, prospective cohort study involved consecutive patients admitted for acute upper gastrointestinal bleeding. Multivariate logistic regression was used to derive CPRs on two thirds of the cohort (derivation set) that predicted bleeding-specific outcomes (rebleeding, need for urgent surgery, or hospital death [poor outcome 1]) and bleeding-specific outcomes plus new or worsening comorbidity (poor outcome 2). Both CPRs were then tested on the remaining third of the cohort (validation set). RESULTS: A total of 391 individuals (99% men; mean age, 63.4 years) were enrolled, of which 4.6% rebled and 3.1% died. Independent predictors of poor outcome 1 were APACHE (Acute Physiology and Chronic Health Evaluation) II score of 11 or greater, esophageal varices, and stigmata of recent hemorrhage. Predictors of poor outcome 2 were these 3 factors plus unstable comorbidity on admission. Of patients with no risk factors, only 1 (1.1%) of 92 experienced poor outcome 1 and only 6 (6.2%) of 97 experienced poor outcome 2. Risks in the validation set were comparable. The CPRs identified 37.8% and 32.2% of patients in the derivation and validation sets, respectively, who were eligible for a shorter hospital stay. CONCLUSIONS: Patients admitted with acute upper gastrointestinal bleeding were unlikely to have a poor outcome if these risk factors were absent. These CPRs might make hospital management more efficient by identifying low-risk patients for whom early hospital discharge is possible.

Sensory modality, temperament, and the development of sustained attention: a vigilance study in children and adults.

Applying optimal stimulation theory, the present study explored the development of sustained attention as a dynamic process. It examined the interaction of modality and temperament over time in children and adults. Second-grade children and college-aged adults performed auditory and visual vigilance tasks. Using the Carey temperament questionnaires (S. C. McDevitt & W. B. Carey, 1995), the authors classified participants according to temperament composites of reactivity and task orientation. In a preliminary study, tasks were equated across age and modality using d' matching procedures. In the main experiment, 48 children and 48 adults performed these calibrated tasks. The auditory task proved more difficult for both children and adults. Intermodal relations changed with age: Performance across modality was significantly correlated for children but not for adults. Although temperament did not significantly predict performance in adults, it did for children. The temperament effects observed in children--specifically in those with the composite of reactivity--occurred in connection with the auditory task and in a manner consistent with theoretical predictions derived from optimal stimulation theory.

Equating tasks and sustaining attention in children and adults: the methodological and theoretical utility of d' matching.

The present study develops a method to create task equivalency for children and adults in vigilance research. Experiment 1 employed the signal detection index of perceptual sensitivity (d') to calibrate vigilance tasks for 32 children (ages 7-8) and 32 adults. The results of Experiment 1 suggest that task equivalency across groups can be attained, and a vigilance decrement was observed for children. In Experiment 2, the task parameter of event rate was manipulated across two vigils. Again, 32 children (ages 7-8) and 32 adults participated. The results suggest that a reverse event rate effect emerged for both children and adults. In addition, developmental differences in response to the event rate manipulation and with respect to the vigilance decrement emerged: Children benefited less from the manipulation and were more likely to demonstrate a vigilance decrement than were adults. No developmental differences emerged for the sensitivity decrement. The results are explained with reference to how task demands interact with participant arousal, and implications for development and for future research are discussed.