BackgroundThe course of Alzheimer’s disease (AD) includes a 10–20-year preclinical period with progressive accumulation of amyloid β (Aβ) plaques and neurofibrillary tangles in the absence of symptomatic cognitive or functional decline. The duration of this preclinical stage in part depends on the rate of pathologic progression, which is offset by compensatory mechanisms, referred to as cognitive reserve (CR). Comorbid medical conditions, psychosocial stressors, and inappropriate medication use may lower CR, hastening the onset of symptomatic AD. Here, we describe a randomized controlled trial (RCT) designed to test the efficacy of a medication therapy management (MTM) intervention to reduce inappropriate medication use, bolster cognitive reserve, and ultimately delay symptomatic AD.Methods/designOur study aims to enroll 90 non-demented community-dwelling adults ≥ 65 years of age. Participants will undergo positron emission tomography (PET) scans, measuring Aβ levels using standardized uptake value ratios (SUVr). Participants will be randomly assigned to MTM intervention or control, stratified by Aβ levels, and followed for 12 months via in-person and telephone visits. Outcomes of interest include: (1) medication appropriateness (measured with the Medication Appropriateness Index (MAI)); (2) scores from Trail Making Test B (TMTB), Montreal Cognitive Assessment (MoCA), and California Verbal Learning Test (CVLT); (3) perceived health status (measured with the SF-36). We will also evaluate pre- to post-intervention change in: (1) use of inappropriate medications as measured by MAI; 2) CR Change Score (CRCS), defined as the difference in scopolamine-challenged vs unchallenged cognitive scores at baseline and follow-up. Baseline Aβ SUVr will be used to examine the relative impact of preclinical AD (pAD) pathology on CRCS, as well as the interplay of amyloid burden with inappropriate medication use.DiscussionThis manuscript describes the protocol of INCREASE (“INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer’s Symptomatic Expression”): a randomized controlled trial that investigates the impact of deprescribing inappropriate medications and optimizing medication regimens on potentially delaying the onset of symptomatic AD and AD-related dementias.Trial registrationClinicalTrials.gov, NCT02849639. Registered on 29 July 2016.
In June 2020, preliminary results for the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial conducted in the UK indicated benefit from dexamethasone in severely ill hospitalized patients with COVID-19 but potential harm in those not requiring oxygen. 1,2 In October 2020, the National Institutes of Health (NIH) issued COVID-19 treatment guidelines advising against systemic corticosteroid use in patients with mild to moderate COVID-19. 1 Using 2 large US health care claims databases, we examined systemic corticosteroid use among nonhospitalized patients with COVID-19.Methods | Data from Medicare fee-for-service and the US Food and Drug Administration's (FDA's) Sentinel System were used. Medicare is a federal health insurance program mostly serv-ing those aged 65 years or older. 3 The Sentinel System comprises primarily claims data from commercially insured patients of all ages in a distributed network of data partners. 4 The Sentinel Rapid COVID-19 data source used in this analysis included 2 national insurance claims data partners and 2 integrated delivery care systems.Nonhospitalized, noninstitutionalized patients with incident COVID-19 between April 2020 and August 2021 (July 2021 for Sentinel) were included. Incident outpatient COVID-19 was defined as a diagnosis code for COVID-19 or positive SARS-CoV-2 laboratory test (Sentinel only) recorded on an outpatient claim, including emergency department claims without subsequent hospitalization. Those with COVID-19 within the prior 183 days and those with use of systemic corticosteroids within the prior 90 days were excluded. Patients were followed up from COVID-19 diagnosis date until the earliest occurrence of a claim for a new oral or injectable corticosteroid in an outpatient setting, hospitalization, death, disenrollment, or 14 days. Demographics, clinical characteristics, and among corticosteroid initiators, corticosteroid type, timing,
Background: Patients' attitudes toward deprescribing are crucial to understand before developing interventions, but no such data exists in the medically underserved, health disparities population of rural Appalachian United States. Objective(s):Assess Appalachian women's openness to deprescribing medications and determine if polypharmacy influenced their attitudes toward deprescribing.Methods: Before and after a cognitive behavioral therapy intervention, middle-aged Appalachian women self-reported medication use and completed the revised Patients' Attitudes Toward Deprescribing Questionnaire (rPATD). Responses were described, stratified by presence of polypharmacy.Results: 30 women completed the rPATD pre-and post-intervention (mean [SD] age 55.8 [6.6] years; 96.7% white). Those with polypharmacy (n = 16) had higher burden and involvement scores (median 2.8 vs 2.0, p = 0.01; 4.9 vs 4.6, p = 0.06), and lower appropriateness scores (3.4 vs 3.9, p = 0.04). Burden, concerns about stopping, and involvement factor scores were similar before and after the intervention (p = 0.08, 0.86, and 0.41 respectively). ≥90% of participants were satisfied with their current medications yet would be willing to stop one or more. Conclusions: Middle-aged women in rural Appalachian United States are open to deprescribing; polypharmacy is associated with lower belief in the appropriateness of medications. Larger studies are needed to inform future deprescribing interventions for this and other similarly disadvantaged populations.
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