Patient Reported Outcomes in Sickle Cell Disease Examined Within a Conceptual Model

Objective: To examine the relations between patient reported outcomes (PROs) within a conceptual model for adults with sickle cell disease (SCD) ages 18 – 45 years enrolled in the Sickle Cell Disease Implementation Consortium (SCDIC) registry. We hypothesized that patient and SCD related factors and barriers to care would independently contribute to functioning as measured using the PRO domains. Additionally, pain and other SCD related complications are expected to impact the relation between the variables. Methods: Participants completed a 48-item survey that included socio-demographics and PRO measures, such as social functioning, pain impact emotional distress, and cognitive functioning. Participants reported on lifetime SCD complications, pain episode frequency, timing and severity, and barriers to medical care. Healthcare utilization was obtained from medical records abstractions. Results: Higher pain frequency and severity and history of treatment for depression were associated with higher odds of worse outcomes in almost all PRO domains, controlling for age and gender for the 2,054 participants. Such social determinants of health as lower household income and unemployment, particularly due to disability status, were associated with higher odds of worse outcomes. Reports of fewer individual barriers to care were associated with better outcomes in emotion, social, cognitive and fatigue domains, while reports of fewer self-reported SCD complications/treatments were associated with better outcomes in emotion and sleep impact domains. Conclusions: Study results highlight the importance of the biopsychosocial model to enhance understanding of the needs of this complex population, and to design multi-dimensional approaches for providing more effective interventions to improve outcomes. @font-face {font-family: Cambria Math ; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-pitch:variable; mso-font-signature:-536870145 1107305727 0 0 415 0;}@font-face {font-family:Times; panose-1:2 0 5 0 0 0 0 0 0 0; mso-font-charset:0; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1342185562 0 0 415 0;}p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent: ; margin:0in; mso-pagination:widow-orphan; font-size:12.0pt; font-family: Times New Roman ,serif; mso-fareast-font-family: Times New Roman ;}.MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family: Calibri ,sans-serif; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family: Times New Roman ; mso-bidi-theme-font:minor-bidi;}div.WordSection1 {page:WordSection1;

Nutritional Avocado Intervention Improves Physical Activity Measures in Hispanic/Latino Families: A Cluster RCT

Introduction: Nutrition and physical activity are key components for the prevention of cardiovascular disease. There remains a paucity of trial data on the effect of specific nutritional interventions on physical activity and sedentary time. One question is how a common nutrient-dense food such as avocado may impact physical activity and sedentary time in Hispanic/Latino families, a group that reports the lowest levels of physical activity. Design: This is a 6-month clustered RCT. Setting/participants: Seventy-two families (235 individuals) who identified as Hispanic/Latino were enrolled through the San Ysidro Health Center (San Diego, CA) between April 2017 and June 2018. Intervention: After a 2-week run-in period, 35 families were randomized to the intervention arm (14 avocados/family/week), and 37 families were assigned to the control arm (3 avocados/family/week). Main outcome measures: Linear mixed-effects models were used to assess changes in physical activity (MET minutes per week) between the groups during the 6-month trial. Secondary outcomes included sedentary time (minutes/week), BMI, and systolic and diastolic blood pressures. Results: An adherence goal of >80% was achieved for both arms. Total mean physical activity increased by 2,197 MET minutes per week more in the intervention group (p<0.01) than in the control group, driven by between-group differences in moderate (p<0.01) versus vigorous (p=0.06) physical activity. After accounting for longitudinal repeated measures per participant and nested family effects, total adult physical activity remained significantly higher in the intervention than in the control group (+1,163 MET minutes per week on average per participant), with a significant intervention interaction term (p<0.01). There were no significant changes in sedentary time, BMI, or blood pressure. Conclusions: Higher allocation of avocados was associated with significantly higher physical activity and no adverse changes in BMI or blood pressure, suggesting that this nutritional intervention may have beneficial pleiotropic effects.Trial registration: This study is registered at www.clinicaltrials.gov as NCT02903433