A community-based group randomized trial to increase aspirin use for primary prevention of cardiovascular disease: Study protocol and baseline results for the "Ask About Aspirin" initiative.
Ontology highlight
ABSTRACT: Background
USPSTF evidence-based recommendations for the use of low-dose aspirin for primary prevention of cardiovascular disease were published in 2009. We describe a statewide campaign using innovative methods to educate the public and health communities about appropriate aspirin use.Methods/design
The "Ask About Aspirin" initiative is designed to lower the number of first heart attacks and strokes in the State of Minnesota by promoting the appropriate use of low dose aspirin. A health system intervention combined with an aspirin awareness media campaign will be evaluated in a pragmatic group randomized controlled trial including 267 primary care clinics within 84 health systems over a four year period. Matched pairs of geographic territories will be randomized to intervention (12 territories) or control (12 territories). The primary outcome of appropriate aspirin use will be measured at the individual level, by community-based telephone surveys of 100 participants in each of the 24 geographically determined clusters.Discussion
We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether evidence-based recommendations can be effectively disseminated in multiple health systems.Trial registration
ClinicalTrials.gov: NCT02607917.
SUBMITTER: Duval S
PROVIDER: S-EPMC8121993 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundNational guidelines promote physical activity to prevent cardiovascular disease (CVD), yet no randomized controlled trial has tested whether physical activity reduces CVD.MethodsThe Women's Health Initiative (WHI) Strong and Healthy (WHISH) pragmatic trial used a randomized consent design to assign women for whom cardiovascular outcomes were available through WHI data collection (N = 18 985) or linkage to the Centers for Medicare and Medicaid Services (N30 346), to a physical activity intervention or "usual activity" comparison, stratified by ages 68-99 years (in tertiles), U.S. geographic region, and outcomes data source. Women assigned to the intervention could "opt out" after receiving initial physical activity materials. Intervention materials applied evidence-based behavioral science principles to promote current national recommendations for older Americans. The intervention was adapted to participant input regarding preferences, resources, barriers, and motivational drivers and was targeted for 3 categories of women at lower, middle, or higher levels of self-reported physical functioning and physical activity. Physical activity was assessed in both arms through annual questionnaires. The primary outcome is major cardiovascular events, specifically myocardial infarction, stroke, or CVD death; primary safety outcomes are hip fracture and non-CVD death. The trial is monitored annually by an independent Data Safety and Monitoring Board. Final analyses will be based on intention to treat in all randomized participants, regardless of intervention engagement.ResultsThe 49 331 randomized participants had a mean baseline age of 79.7 years; 84.3% were White, 9.2% Black, 3.3% Hispanic, 1.9% Asian/Pacific Islander, 0.3% Native American, and 1% were of unknown race/ethnicity. The mean baseline RAND-36 physical function score was 71.6 (± 25.2 SD). There were no differences between Intervention (N = 24 657) and Control (N = 24 674) at baseline for age, race/ethnicity, current smoking (2.5%), use of blood pressure or lipid-lowering medications, body mass index, physical function, physical activity, or prior CVD (10.1%).ConclusionThe WHISH trial is rigorously testing whether a physical activity intervention reduces major CV events in a large, diverse cohort of older women. Clinical Trials Registration Number: NCT02425345.
| S-EPMC8011700 | biostudies-literature
Project description:BackgroundIn patients with atherosclerotic cardiovascular disease, increasing age is concurrently associated with higher risks of ischemic and bleeding events. The objectives are to determine the impact of aspirin dose on clinical outcomes according to age in atherosclerotic cardiovascular disease.Methods and resultsIn the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) trial, patients with atherosclerotic cardiovascular disease were randomized to daily aspirin doses of 81 mg or 325 mg. The primary effectiveness end point was death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke. The primary safety end point was hospitalization for bleeding requiring transfusion. A total of 15 076 participants were randomized to aspirin 81 mg (n=7540) or 325 mg (n=7536) daily (median follow-up: 26.2 months; interquartile range: 19.0-34.9 months). Median age was 67.6 years (interquartile range: 60.7-73.6 years). Among participants aged <65 years (n=5841 [38.7%]), a primary end point occurred in 226 (7.54%) in the 81 mg group, and in 191 (6.80%) in the 325 mg group (adjusted hazard ratio [HR], 1.23 [95% CI, 1.01-1.49]). Among participants aged ≥65 years (n=9235 [61.3%]), a primary end point occurred in 364 (7.12%) in the 81 mg group, and in 378 (7.96%) in the 325 mg group (adjusted HR, 0.95 [95% CI, 0.82-1.10]). The age-dose interaction was not significant (P=0.559). There was no significant interaction between age and the randomized aspirin dose for the secondary effectiveness and the primary safety bleeding end points (P>0.05 for all).ConclusionsAge does not modify the impact of aspirin dosing (81 mg or 325 mg daily) on clinical end points in secondary prevention of atherosclerotic cardiovascular disease.
| S-EPMC11010083 | biostudies-literature
Project description:PurposeThe National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual.MethodsEP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the median were considered high-accruing sites. Analyses were performed to identify site characteristics associated with higher accrual onto EP trials.ResultsTwenty-seven of the 30 NCCCP sites participated. The median number of EP trials open per site over the course of July 2010-June 2011 was 19. Median EP accrual per site was 14 patients in 1 year. Approximately half of the EP trials were Cooperative Group; most were phase II. Except for having a higher number of EP trials open (P = .04), high-accruing sites (n = 14) did not differ significantly from low-accruing sites (n = 13) in terms of any single site characteristic. High-accruing sites did have shorter institutional review board (IRB) turnaround time by 20 days, and were almost three times as likely to be a lead Community Clinical Oncology Program site (small sample size may have prevented statistical significance). Most sites had at least basic EP trial infrastructure.ConclusionCommunity cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.
| S-EPMC3595451 | biostudies-literature
Project description:BackgroundThe role of aspirin in reducing lipoprotein(a)-mediated atherothrombotic events in primary prevention is not established.ObjectivesThis study sought to assess whether low-dose aspirin benefits individuals with elevated plasma lipoprotein(a)-associated genotypes in the setting of primary prevention.MethodsThe study analyzed 12,815 genotyped individuals ≥70 years of age of European ancestry and without prior cardiovascular disease events enrolled in the ASPREE (ASPirin in Reducing Events in the Elderly) randomized controlled trial of 100 mg/d aspirin. We defined lipoprotein(a)-associated genotypes using rs3798220-C carrier status and quintiles of a lipoprotein(a) genomic risk score (LPA-GRS). We tested for interaction between genotypes and aspirin allocation in Cox proportional hazards models for incidence of major adverse cardiovascular events (MACE) and clinically significant bleeding. We also examined associations in the aspirin and placebo arms of the trial separately.ResultsDuring a median 4.7 years (IQR: 3.6-5.7 years) of follow-up, 435 MACE occurred, with an interaction observed between rs3798220-C and aspirin allocation (P = 0.049). rs3798220-C carrier status was associated with increased MACE risk in the placebo group (HR: 1.90; 95% CI: 1.11-3.24) but not in the aspirin group (HR: 0.54; 95% CI: 0.17-1.70). High LPA-GRS (vs low) was associated with increased MACE risk in the placebo group (HR: 1.70; 95% CI: 1.14-2.55), with risk attenuated in the aspirin group (HR: 1.41; 95% CI: 0.90-2.23), but the interaction was not statistically significant. In all participants, aspirin reduced MACE by 1.7 events per 1,000 person-years and increased clinically significant bleeding by 1.7 events per 1,000 person-years. However, in the rs3798220-C and high LPA-GRS subgroups, aspirin reduced MACE by 11.4 and 3.3 events per 1,000 person-years respectively, without significantly increased bleeding risk.ConclusionsAspirin may benefit older individuals with elevated lipoprotein(a) genotypes in primary prevention.
| S-EPMC10025998 | biostudies-literature
Project description:Background: The value of aspirin for primary prevention continues to be debated. Data showing whether aspirin use for primary prevention adheres to established guidelines in real world practice are sparse. Methods: A total of 13,104 patients without cardiovascular diseases (CVD) were selected from the DYS-lipidemia International Study of China, a national survey of patients with dyslipidemia in 2012. The CVD risk of the participants were calculated using the 10-year risk of Ischemic Cardiovascular Diseases model. The misuse of aspirin for primary prevention was defined as having CVD risk <10% with daily aspirin. Multivariate logistic regression models were used to explore risk factors associated with aspirin misuse. Results: The proportion of the patients categorized as low, moderate and high risk for CVD were 52.9, 21.6, and 25.4% respectively. The misuse frequency of aspirin was 31.0% (2,147/6,933) in patients with low risk. The misuse of aspirin increased with aging for both men and women. In the multivariate analysis, the independent risk factors associated with aspirin misuse were hypertension, diabetes mellitus, a family history of premature CVD, and elderly age. Level of total cholesterol is negatively associated with aspirin misuse. Patients from low level hospitals are more likely to be taking aspirin inappropriately. Results remained consistent after including 2,837 patients having 10-year risk for CVD between 10 and <20%. Conclusion: The misuse of aspirin for primary prevention is common in patients having CVD risk <10%. There are important opportunities to improve evidence-based aspirin use for the primary prevention of CVD in Chinese patients. Clinical Trial Registration:https://clinicaltrials.gov/, identifier [NCT01732952].
| S-EPMC8446611 | biostudies-literature
Project description:IntroductionThe Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease (API ADAD) Trial evaluated the anti-oligomeric amyloid beta (Aβ) antibody therapy crenezumab in cognitively unimpaired members of the Colombian presenilin 1 (PSEN1) E280A kindred. We report availability, methods employed to protect confidentiality and anonymity of participants, and process for requesting and accessing baseline data.MethodsWe developed mechanisms to share baseline data from the API ADAD Trial in consultation with experts and other groups sharing data from Alzheimer's disease (AD) prevention trials, balancing the need to protect anonymity and trial integrity with making data broadly available to accelerate progress in the field. We pressure-tested deliberate and inadvertent potential threats under specific assumptions, employed a system to suppress or mask both direct and indirect identifying variables, limited and firewalled data managers, and put forth specific principles requisite to receive data.ResultsBaseline demographic, PSEN1 E280A and apolipoprotein E genotypes, florbetapir and fluorodeoxyglucose positron emission tomography, magnetic resonance imaging, clinical, and cognitive data can now be requested by interested researchers.DiscussionBaseline data are publicly available; treatment data and biological samples, including baseline and treatment-related blood-based biomarker data will become available in accordance with our original trial agreement and subsequently developed Collaboration for Alzheimer's Prevention principles. Sharing of these data will allow exploration of important questions including the differential effects of initiating an investigational AD prevention therapy both before as well as after measurable Aβ plaque deposition.
| S-EPMC10262848 | biostudies-literature
Project description:BackgroundThe Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) was designed to address whether non-steroidal anti-inflammatory drugs (NSAIDs) can prevent or delay the onset of Alzheimer's disease (AD).MethodsADAPT was a randomized, double-placebo-controlled, multicenter chemoprevention trial conducted at six U.S. dementia research clinics. At entry, participants were required to test "normal" on a battery of cognitive tests and to be age 70+ with a family history of Alzheimer-like dementia. Persons were randomly assigned to 200 mg b.i.d. celecoxib (Celebrex, Pfizer), 220 mg b.i.d. naproxen sodium (Aleve, Bayer), or placebo. The primary outcome measure was AD. Secondary outcome measures were cognitive decline and measures related to safety of the treatments when used long term. ADAPT was designed to detect a 30% reduction in AD incidence with 80% power. The estimated sample size requirement was 2,625.ResultsEnrollment began in March 2001 and ended in December 2004 when treatments were suspended because of concerns regarding cardiovascular safety of the treatments. Followup ranged from 1 to 46 months. The achieved enrollment was 2,528. Recruitment was achieved primarily via mailings to people aged 70+ living in the catchment areas of the six field sites.
| S-EPMC2866447 | biostudies-literature
Project description:The Cardiovascular Health Program (CHP) Registry is a 12-month, prospective study of therapeutic lifestyle change (TLC). Adult participants received comprehensive assessment of health behaviors and cardiovascular disease (CVD) risk factors. Personalized TLC action plans addressed modifiable health behaviors for diet, exercise, stress management, and sleep. Participants attended a half-day interactive workshop and met face-to-face with certified health coaches four times over 6 months. Monthly telephonic coaching for 6 more months completed the intervention. Measured outcomes included adherence to behavioral prescriptions, anthropometrics, CVD-relevant laboratory tests, and for a subset of participants, carotid intima-media thickness (CIMT). Of 965 participants, 648 (67%) completed the program and were included in the analysis. Participants were of mean age 55.4 ± 12.5 years, 57% women, and racially diverse. Adherence to prescribed TLC was substantial: dietary behaviors at goal rose from 53% to 86%, exercise 44% to 66%, perceived stress 65% to 79%, and sleep quality 28% to 49%. For participants with abnormal anthropometrics at baseline, there were improvements in body mass index in 63%, waist circumference (men 71%, women 74%), systolic BP 69%, and diastolic BP 71%. For participants with abnormal laboratory values at baseline, there were improvements in total cholesterol in 74%, LDL-cholesterol 65%, triglycerides 86%, fasting glucose 72%, and insulin resistance 71%. Improvements were not driven by prescribed medications. CIMT improved or showed no change in 70% of those measured, associated with significant improvements in sleep quality and longer total sleep time. Longer trials incorporating controls and major adverse CVD events are warranted.
| S-EPMC8020477 | biostudies-literature
Project description:IntroductionMental health services are fragmented in Australia leading to a priority being placed on whole-of-community approaches and integration. We describe the LifeSpan suicide prevention intervention developed by the Black Dog Institute that draws upon nine evidence-based community-wide strategies. We examined the suicide prevention Collaborative group at each site. We evaluated how the social capital of the community and service providers changed, and how the brokerage roles of the Collaborative affected integration of effort.MethodsThis was a two phase, explanatory mixed methods study. Participants were LifeSpan Coordinators, The Collaborative and working group members at four LifeSpan sites in New South Wales (three metropolitan/regional, one regional/rural). Quantitative social network data was collected through an online survey and analysed using Gephi software. Qualitative data through focus groups and interviews with Lifespan Coordinators and community stakeholders.ResultsThe social network survey was administered in three sites and was completed by 83 people. Data gave quantitative evidence of increased engagement across key stakeholders in each region who had not previously been working together. Nominations of other collaborators showed this network extended beyond the formal structures of The Collaborative. LifeSpan Coordinators were empirically identified as key players in the networks. Qualitative data was collected from 53 individuals (18 interviews and five focus groups) from across all sites. Participants identified benefits of this collaborative approach including greater capacity to run activities, better communication between groups, identification of "who's who" locally, improvement in the integration of priorities, services and activities, and personal support for previously isolated members. LifeSpan Coordinators were key to the smooth running of The Collaborative. This may represent a risk to sustainability if they left. The collaboration model that suited metropolitan sites was difficult to sustain in rural sites, but gains were seen in better coordinated postvention efforts.ConclusionLifeSpan Coordinators were noted to be exceptional people who magnified the benefits of collaboration. Geographic proximity was a potent driver of social capital. Initial engagement with local stakeholders was seen as essential but time-consuming work in the implementation phase. Coordinators reported this important work was not always acknowledged as part of their formal role.
| S-EPMC8822835 | biostudies-literature
Project description:BackgroundThe benefits of aspirin for primary prevention of stroke are uncertain.MethodsWe performed a cumulative meta-analysis of trials investigating aspirin for primary prevention of cardiovascular disease with a focus on stroke. We assessed the effects of aspirin on non-fatal stroke, hemorrhagic stroke, non-fatal myocardial infarction, all-cause mortality, cardiovascular mortality, major gastrointestinal bleeding, and an analysis of net clinical effect, in populations without a history of clinical or subclinical cardiovascular disease.Summary of review resultsAmong 11 trials (157,054 participants), aspirin was not associated with a statistically significant reduction in non-fatal stroke (odds ratio, 0.94; 95% CI, 0.85 to 1.04) but was associated with an increased risk of hemorrhagic stroke (odds ratio, 1.29; 95% CI, 1.06 to 1.56). Aspirin was not associated with a statistically significant reduction in all-cause mortality (odds ratio, 0.97; 95% CI, 0.92 to 1.03) or cardiovascular mortality (odds ratio, 0.94; 95% CI, 0.85 to 1.03). Aspirin was associated with a reduction in non-fatal myocardial infarction (odds ratio, 0.80; 95% CI, 0.69 to 0.94) and an increased risk of major gastrointestinal bleeding (odds ratio, 1.83; 95% CI, 1.43 to 2.35). Using equal weighting for non-fatal events and major bleeding, we observed no net clinical benefit with aspirin use for primary prevention.ConclusionOur meta-analysis reports no benefit of aspirin for primary stroke prevention.
| S-EPMC7003154 | biostudies-literature