Harvest for Health, a Randomized Controlled Trial Testing a Home-Based, Vegetable Gardening Intervention Among Older Cancer Survivors Across Alabama: An Analysis of Accrual and Modifications Made in Intervention Delivery and Assessment During COVID-19.

BACKGROUND: Accelerated functional decline is a concern among older cancer survivors that threatens independence and quality of life. Pilot studies suggest that vegetable gardening interventions ameliorate functional decline through improved diet and physical activity. OBJECTIVE: The aim of this article was to describe the rationale, recruitment challenges, and enrollment for the Harvest for Health randomized controlled trial (RCT), which will test the impact of a home-based, vegetable gardening intervention on vegetable and fruit consumption, physical activity, and physical functioning among older cancer survivors. Modifications made to the intervention and assessments to assure safety and continuity of the RCT throughout the COVID-19 pandemic also are reported. DESIGN: Harvest for Health is a 2-year, 2-arm, single-blinded, wait-list controlled RCT with cross-over. PARTICIPANTS/SETTING: Medicare-eligible survivors of cancers with ≥60% 5-year survival were recruited across Alabama from October 1, 2016 to February 8, 2021. INTERVENTION: Participants were randomly assigned to a wait-list control or a 1-year home-based gardening intervention and individually mentored by extension-certified master gardeners to cultivate spring, summer, and fall vegetable gardens. MAIN OUTCOME MEASURES: Although the RCT's primary end point was a composite measure of vegetable and fruit consumption, physical activity, and physical functioning, this article focuses on recruitment and modifications made to the intervention and assessments during COVID-19. STATISTICAL ANALYSES PERFORMED: χ2 and t tests (α < .05) were used to compare enrolled vs unenrolled populations. RESULTS: Older cancer survivors (n = 9,708) were contacted via mail and telephone; 1,460 indicated interest (15% response rate), 473 were screened eligible and consented, and 381 completed baseline assessments and were randomized. Enrollees did not differ from nonrespondents/refusals by race and ethnicity, or rural-urban status, but comprised significantly higher numbers of comparatively younger survivors, those who were female, and survivors of breast cancer (P < .001). Although COVID-19 delayed trial completion, protocol modifications overcame this barrier and study completion is anticipated by June 2022. CONCLUSIONS: This RCT will provide evidence on the effects of a mentored vegetable gardening program among older cancer survivors. If efficacious, Harvest for Health represents a novel, multifaceted approach to improve lifestyle behaviors and health outcomes among cancer survivors-one with capacity for sustainability and widespread dissemination.

Emergent Admissions to the Epilepsy Monitoring Unit in the Setting of COVID-19 Pandemic-related, State-mandated Restrictions: Clinical Decision Making and Outcomes.

Due to the coronavirus disease 2019 (COVID-19) pandemic, the state of Texas-limited elective procedures to conserve beds and personal protective equipment (PPE); therefore, between March 22 and May 18, 2020, admission to the epilepsy monitoring unit (EMU) was limited only to urgent and emergent cases. We evaluated clinical characteristics and outcomes of these patients who were admitted to the EMU. Nineteen patients were admitted (one patient twice) with average age of 36.26 years (11 female) and average length of stay 3 days (range: 2-9 days). At least one event was captured on continuous EEG (cEEG) and video monitoring in all 20 admissions (atypical in one). One patient had both epileptic (ES) and psychogenic non-epileptic seizures (PNES) while 10 had PNES and 9 had ES. In 8 of 9 patients with ES, medications were changed, while in 5 patients with PNES, anti-epileptic drugs (AED) were stopped; the remaining 5 were not on medications. Of the 14 patients who had seen an epileptologist pre-admission, 13 (or 93%) had their diagnosis confirmed by EMU stay; a statistically significant finding. While typically an elective admission, in the setting of the COVID-19 pandemic, urgent and emergent EMU admissions were required for increased seizure or event frequency. In the vast majority of patients (13 of 19), admission lead to medication changes to either better control seizures or to change therapeutics as appropriate when PNES was identified.