scholarly journals A multicenter, open-label, pilot study evaluating the functionality of an integrated call center for a digital medicine system to optimize monitoring of adherence to oral aripiprazole in adult patients with serious mental illness

2017 ◽  
Vol Volume 13 ◽  
pp. 2641-2651 ◽  
Author(s):  
Alex Kopelowicz ◽  
Ross A. Baker ◽  
Cathy Zhao ◽  
Claudette Brewer ◽  
Erica Lawson ◽  
...  
Keyword(s):  
Mental Illness ◽  
Pilot Study ◽  
Serious Mental Illness ◽  
Call Center ◽  
Adult Patients ◽  
Open Label ◽  
Digital Medicine

Pilot Study to Evaluate the Efficacy and Safety of Oral Tacrolimus in Adult Patients With Refractory Severe Plaque Psoriasis

2015 ◽  
Vol 20 (3) ◽  
pp. 228-232 ◽  
Author(s):  
Ankit Mittal ◽  
Sunil Dogra ◽  
Tarun Narang ◽  
Aman Sharma
Keyword(s):  
Pilot Study ◽  
Plaque Psoriasis ◽  
Severity Index ◽  
Term Treatment ◽  
Adult Patients ◽  
Efficacy And Safety ◽  
Open Label ◽  
Short Term Treatment ◽  
Psoriasis Area Severity Index ◽  
Severe Plaque Psoriasis

Background: Tacrolimus, a congener of cyclosporine, has replaced cyclosporine as a first-line treatment for most transplant patients due to its superior efficacy and safety. Tacrolimus has not been extensively studied for the treatment of psoriasis. Objectives: To study the efficacy and safety of oral tacrolimus in adult patients with severe refractory plaque psoriasis. Methods: This was an open-label pilot study. Patients with severe plaque type psoriasis who were unresponsive to at least 1 systemic treatment were treated with oral tacrolimus. Results: Thirty patients were treated. After 12 weeks, improvement in mean Psoriasis Area Severity Index (PASI) score was 80.37% ( P < .001), PASI 75 was observed in 19 of 26 (73.1%) patients, and PASI 90 was observed in 11 of 26 (42.3%) patients. No severe side effects were noted. Conclusion: Oral tacrolimus is an effective and safe option for the short-term treatment of severe plaque psoriasis.

Dexmedetomidine for hyperactive delirium at the end of life: An open-label single arm pilot study with dose escalation in adult patients admitted to an inpatient palliative care unit

2021 ◽  
pp. 026921632199444
Author(s):  
Benjamin Thomas ◽  
Wing-Shan Angela Lo ◽  
Zivai Nangati ◽  
Greg Barclay
Keyword(s):  
Palliative Care ◽  
Pilot Study ◽  
End Of Life ◽  
Standard Care ◽  
Dose Schedule ◽  
Adult Patients ◽  
Target Range ◽  
High Dose ◽  
Current Standard ◽  
Open Label

Background: Terminal delirium, specifically the hyperactive delirium subtype at the end of life, is common in palliative care patients. Standard care often involves sedation to alleviate distress. The alpha2-adrenoreceptor agonist dexmedetomidine may have promise in terminal delirium, due to its properties of decreasing delirium and permitting rousable sedation. Aim: This study aimed to describe the effect of dexmedetomidine on delirium and sedation, when delivered via continuous subcutaneous infusion (CSCI) in patients with terminal delirium. Design: The trial was prospectively registered in the ANZCTR database (ACTRN12618000658213) and conducted in accordance with CONSORT (pilot study extension). Twenty-two adult patients were treated with a CSCI of dexmedetomidine with a two-tier dose schedule, low and high dose. Delirium severity was measured by the Memorial Delirium Assessment Scale (MDAS, target <13), and sedation by the Richmond Agitation-Sedation Scale, Palliative Version (RASS-PAL, target −1 to −3). Results: All patients had a response to dexmedetomidine as measured by decrease in MDAS after initiation; 59% required escalation to high dose to maintain control of delirium. All responses to high dose were sustained. RASS-PAL scores showed significant variability, however mean scores remained within target range on both doses, and the majority of patients were rousable. Fifty percent of patients treated crossed over to standard care; no patients who crossed over were experiencing moderate-severe delirium. Predominant reason for crossover was family request for deeper sedation. Conclusion: Dexmedetomidine shows potential for the management of terminal delirium with improved interactivity. Further research is needed to determine efficacy compared to current standard care.

scholarly journals Detection of Behavioral Anomalies in Medication Adherence Patterns Among Patients With Serious Mental Illness Engaged With a Digital Medicine System (Preprint)

2020 ◽  
Author(s):  
Jonathan Knights ◽  
Zahra Heidary ◽  
Jeffrey M Cochran
Keyword(s):  
Clinical Trial ◽  
Mental Illness ◽  
Medication Adherence ◽  
Anomaly Detection ◽  
Serious Mental Illness ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Reference Sequence ◽  
Sequence Of Events ◽  
Digital Medicine

BACKGROUND Adherence to medication is often represented in the form of a success percentage over a period of time. Although noticeable changes to aggregate adherence levels may be indicative of unstable medication behavior, a lack of noticeable changes in aggregate levels over time does not necessarily indicate stability. The ability to detect developing changes in medication-taking behavior under such conditions in real time would allow patients and care teams to make more timely and informed decisions. OBJECTIVE This study aims to develop a method capable of identifying shifts in behavioral (medication) patterns at the individual level and subsequently assess the presence of such shifts in retrospective clinical trial data from patients with serious mental illness. METHODS We defined the term <i>adherence volatility</i> as <i>“the degree to which medication ingestion behavior fits expected behavior based on historically observed data”</i> and defined a contextual anomaly system around this concept, leveraging the empirical entropy rate of a stochastic process as the basis for formulating anomaly detection. For the presented methodology, each patient’s evolving behavior is used to dynamically construct the expectation bounds for each future interval, eliminating the need to rely on model training or a static reference sequence. RESULTS Simulations demonstrated that the presented methodology identifies anomalous behavior patterns even when aggregate adherence levels remain constant and highlight the temporal dependence inherent in these anomalies. Although a given sequence of events may present as anomalous during one period, that sequence should subsequently contribute to future expectations and may not be considered anomalous at a later period—this feature was demonstrated in retrospective clinical trial data. In the same clinical trial data, anomalous behavioral shifts were identified at both high- and low-adherence levels and were spread across the whole treatment regimen, with 77.1% (81/105) of the population demonstrating at least one behavioral anomaly at some point in their treatment. CONCLUSIONS Digital medicine systems offer new opportunities to inform treatment decisions and provide complementary information about medication adherence. This paper introduces the concept of <i>adherence volatility</i> and develops a new type of contextual anomaly detection, which does not require an a priori definition of <i>normal</i> and allows expectations to evolve with shifting behavior, removing the need to rely on training data or static reference sequences. Retrospective analysis from clinical trial data highlights that such an approach could provide new opportunities to meaningfully engage patients about potential shifts in their ingestion behavior; however, this framework is not intended to replace clinical judgment, rather to highlight elements of data that warrant attention. The evidence provided here identifies new areas for research and seems to justify additional explorations in this area.

Abstract P008: Weight Gain and Cardiovascular Risk Reduction Associated With Tobacco Abstinence in Smokers With Serious Mental Illness

Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
Anne N Thorndike ◽  
Susanne S Hoeppner ◽  
Corinne Cather ◽  
Gladys N Pachas ◽  
Eric D Achtyes ◽  
...  
Keyword(s):  
Mental Illness ◽  
Smoking Cessation ◽  
Weight Gain ◽  
Serious Mental Illness ◽  
Risk Score ◽  
Cvd Risk ◽  
Open Label ◽  
Framingham Risk ◽  
Related Risk ◽  
High Prevalence

Background: In patients with serious mental illness, high prevalence of smoking and obesity-related risk factors contribute to high rates of cardiovascular disease (CVD) and premature mortality. The impact of smoking cessation on weight gain, obesity-related risk factors, and overall cardiovascular risk among this population is unknown. Methods: We conducted secondary analyses to assess weight gain and change in CVD risk of 87 smokers with serious mental illness (schizophrenia, schizoaffective disorder, and bipolar disorder) who participated in a randomized controlled trial to test the long-term effectiveness of varenicline on smoking cessation. Initially, 203 smokers with serious mental illness were enrolled into an open-label 12-week course of varenicline. Subjects who attained abstinence at the end of the open-label phase were eligible to participate in the randomized phase, and 87 subjects were randomized to continue either varenicline or placebo for the following 40 weeks. Smoking cessation at week 52 (end of treatment) was defined as 21-day point prevalence abstinence. We compared subjects who were abstinent at week 52 (N=33) to subjects who had relapsed to smoking (N=54) on changes in weight and Framingham 10-year CVD risk score over the 52-week trial; outcomes were modeled with repeated measures analyses of variance. Results: At baseline, subjects who achieved week 52 abstinence were older (52 vs. 46 years, p=0.01) and had higher fasting serum glucose (98 vs. 89 mg/dL, p=0.008) than subjects who relapsed, but they did not differ on sex, race, smoking characteristics, blood pressure, lipids, treatment for diabetes, or treatment with antipsychotic medications. Baseline mean body mass index did not differ between abstinent and relapsed subjects (31.4 vs. 32.4, p=0.52), but the baseline mean Framingham risk score was higher for abstinent than relapsed subjects (14.2% vs. 10.8%, p=0.02). Over the 52 week study period, abstinent subjects gained more weight than relapsed subjects (4.8 kg vs. 1.2 kg, p=0.002 for time*abstinence interaction), but the mean Framingham risk score decreased substantially for abstinent subjects and not for relapsed subjects (-7.6% vs. 0.0%, p=0.003 for abstinence effect adjusting for sex, site, varenicline or placebo, and antipsychotic medications). Conclusion: Despite the high prevalence of obesity at baseline and substantial weight gain associated with long-term abstinence, smoking cessation resulted in a large reduction in the Framingham estimated 10-year CVD risk among patients with serious mental illness.

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