Suchergebnisse

INTRODUCTION: Online tools are increasingly utilized in clinical trial recruitment. A/B testing is an effective technology used in political campaigns and commercial marketing to improve contributions or sales. However, to our knowledge, A/B has not been described in the context of clinical trial recruitment. METHODS: Two A/B testing experiments were implemented on the recruitment website of the Study To Understand Fall Reduction and Vitamin D in You (STURDY), a response-adaptive, two-stage, randomized controlled trial. Commercial A/B platforms randomized web-users to different versions of the trial's website landing page; Experiment 1 included two infographic versions and Experiment 2 included three video versions. We compared web-user engagement metrics between each version and the original landing page. We determined the effect of each version compared to the original landing page on the likelihood of a web-user to (1) request more information about the trial, (2) complete a screening visit, or (3) enroll in the trial. RESULTS: A total of 2605 and 374 web-users visited the trial's website during Experiment 1 and 2, respectively. Response to the online interest form significantly differed by infographic version in Experiment 1. The number of individuals who engaged with website content and pages significantly differed by video in Experiment 2. CONCLUSION: In a pilot study implementing A/B testing of a clinical trial recruitment website, different versions of the website led to differences in web-user engagement and interest in the trial. A/B testing tools offer a promising approach to test the effectiveness of clinical trial recruitment materials and to optimize recruitment campaigns.

OBJECTIVES: To determine the feasibility of a low sodium meal plan intervention aimed at reducing seated blood pressure (BP) in residents of a government-subsidized congregate, senior living facility. METHODS: The Satter House Trial of Reduced Sodium Meals (SOTRUE) was an individual-level, masked, randomized, controlled pilot study, testing the feasibility of administering a low versus typical sodium meal plan to adult residents of Jack Satter House, a section 202 congregate living facility in Revere, MA, subsidized by the Federal Department of Housing and Urban Development (HUD). Adults over age 60 years received 3 isocaloric meals with two snacks daily over a 14-day period. Both meal plans were equivalent in potassium and macronutrients, but differed in sodium density ( 2 mg/kcal). The primary outcome was seated systolic BP (SBP) averaged over 2 visits (days 10 and 14) using an Omron HEM-907XL automated cuff. Our objective measure of compliance was morning urine sodium-creatinine ratio. RESULTS: We randomized 20 participants (95% women, 95% white, and mean age 78 +/− 8 years), beginning in October 7, 2019. Baseline characteristics were evenly distributed between groups. Dietary compliance was high (only 2 discontinued meals) and follow-up was 100% with the last participant ending November 4, 2019. Baseline SBP changed from 121 to 116 mm Hg on the typical sodium meal plan (N = 9; mean difference of −5 mm Hg; 95% CI: −18, 8) and 123 to 112 mm Hg on the low sodium meal plan (N = 11; mean difference of −11 mm Hg; 95% CI: −15.2, −7.7). Compared to the typical sodium meal plan, the low sodium meal plan non-significantly reduced SBP by 5 mm Hg (95% CI: −14, 4) and non-significantly reduced urine sodium-creatinine ratio (%-difference −36.0; 95% CI: −60.3, 3.4). Effects on SBP were greater in the subgroup using hypertension medications at baseline (−13 mm Hg; 95% CI: −26, −0) and changes in SBP from baseline were correlated with changes in urine sodium-creatinine ratio (Pearson's r = 0.31). ...

Abstract

Background
Orthostatic hypotension is associated with cardiovascular disease. It remains unclear if low standing blood pressure or high seated blood pressure is responsible for this association. We compared associations of orthostatic hypotension and hypertension with high-sensitivity cardiac troponin I and N-terminal pro-B-type natriuretic peptide.


Methods
We performed a secondary analysis of the Study to Understand Fall Reduction and Vitamin D in You, a randomized controlled trial funded by the National Institute on Aging, between July 2015 and May 2019. Participants were community-dwelling adults, 70 years or older. Blood tests for high-sensitivity cardiac troponin I and N-terminal pro-B-type natriuretic peptide were drawn at visits concurrent with blood pressure measurements. Secondary analysis occurred in 2023. We determined associations between blood pressure phenotypes and cardiac biomarkers.


Results
Of 674 participants (mean age 76.5 ± 5.4 years, 43% female, 17.2% Black race), 29.1% had prior cardiovascular disease. Participants with seated hypertension had 10.1% greater high-sensitivity cardiac troponin I (95% confidence interval = 3.8–16.9) and 11.0% greater N-terminal pro-B-type natriuretic peptide (4.0–18.6) than those without seated hypertension. Participants with standing hypertension had 8.6% (2.7–14.9) greater high-sensitivity cardiac troponin I and 11.8% greater N-terminal pro-B-type natriuretic peptide (5.1–18.9) than those without standing hypertension. Hypotensive phenotypes were not associated with either biomarker.


Conclusions
Both seated and standing hypertension were associated with greater high-sensitivity cardiac troponin I and N-terminal pro-B-type natriuretic peptide, but hypotensive phenotypes were not. Hypoperfusion may not be the principal mechanism behind subclinical cardiac injury among older adults with orthostatic hypotension.

AbstractBackgroundStudies of the relationship between vitamin D and physical functioning have had inconsistent results.MethodsPhysical functioning measures were collected for up to 2 years during a 2-stage, Bayesian, response-adaptive, randomized trial of 4 doses of vitamin D3 supplementation (200 [control], 1 000, 2 000, and 4 000 IU/day) to prevent falls. Two community-based research units enrolled adults aged ≥70 years, with elevated fall risk and serum 25-hydroxyvitamin D level of 10–29 ng/mL. The Pooled Higher Doses (PHD) group (≥1 000 IU/day, n = 349) was compared to the control group (n = 339) on changes in Short Physical Performance Battery (SPPB) score and its component tests, Timed Up-and-Go (TUG) test, 6-minute walk distance, and grip strength.ResultsThe trial enrolled 688 participants. Mean age was 77.2 years, 56.4% were male, 79.7% White, and 18.2% Black. While the PHD and control groups both lost function over time on most outcomes, the 2 groups did not show differential change overall on any outcome. Incidence of transitioning to poor functioning on gait speed, SPPB score, or TUG test did not differ by dose group.ConclusionIn older persons with low serum 25-hydroxyvitamin D level and elevated fall risk, high-dose vitamin D supplementation, ≥1 000 IU/day, did not improve measures of physical function compared to 200 IU/day.Clinical Trial RegistrationNCT02166333