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A randomized controlled trial in Norwegian pharmacies on effects of risk alert and advice in people with elevated cardiovascular risk.

ABSTRACT: We investigated if alerting subjects to elevated total cholesterol (TC), hemoglobin A1c (HbA1c) and blood pressure (BP) (cardiovascular disease (CVD) risk factors that are usually asymptomatic), and if providing advice would result in reduced risk. We conducted a multicenter (50 community pharmacies) parallel three-arm 8-week randomized controlled trial (RCT) with a 52-week follow-up visit. During six days of screening, TC, HDL- and LDL-cholesterol, triglycerides, HbA1c, BP and body mass index (BMI) were assessed in 1318 individuals. Of these, 582 with a measured and predefined elevated ad hoc CVD risk score were randomized to either Alert/advice (n?=?198) (immediately alerted of their screening result and received healthy lifestyle-advice), Advice-only (n?=?185) (received only advice) or Control (n?=?199) (not alert, no advice). Changes in risk score and self-reported health-related behaviors (diet, alcohol, physical activity) were assessed in pharmacies after 8?weeks (N?=?543; 93%). Although the primary analysis showed no significant difference between groups, the Control group had the largest reduction in risk score of 14%. The total (uncontrolled) sample (N?=?543) reduced the risk score by 3.2% beyond estimated regression towards the mean and improved their health-related behaviors. Among the 65% (n?=?377) who returned 52?weeks after baseline, 14% reported started using CVD preventive medication after the screening. The study demonstrated that while assessing risk factors and behaviors in pharmacies proved efficient and possibly led to a small risk decrease, alerting people to their screening result did not seem to be more effective than a self-directed approach. ClinicalTrials.gov identifier: NCT02223793.

SUBMITTER: Svendsen K

PROVIDER: S-EPMC6125803 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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A randomized controlled trial in Norwegian pharmacies on effects of risk alert and advice in people with elevated cardiovascular risk.

Svendsen Karianne K Telle-Hansen Vibeke H VH Mørch-Reiersen Lisa T LT Garstad Kjersti W KW Thyholt Kari K Granlund Linda L Henriksen Hege Berg HB Gran Jon Michael JM Jacobs David R DR Retterstøl Kjetil K

Preventive medicine reports 20180809

We investigated if alerting subjects to elevated total cholesterol (TC), hemoglobin A1c (HbA1c) and blood pressure (BP) (cardiovascular disease (CVD) risk factors that are usually asymptomatic), and if providing advice would result in reduced risk. We conducted a multicenter (50 community pharmacies) parallel three-arm 8-week randomized controlled trial (RCT) with a 52-week follow-up visit. During six days of screening, TC, HDL- and LDL-cholesterol, triglycerides, HbA1c, BP and body mass index ( ...[more]

PMID: 30191097

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Project description:Emerging cardiovascular disease (CVD) risk factors, including central vascular function and HDL efflux, may be modifiable with food-based interventions such as cranberry juice. A randomized, placebo-controlled, crossover trial was conducted in middle-aged adults with overweight/obesity (n = 40; mean BMI: 28.7 ± 0.8 kg/m2; mean age: 47 ± 2 years) and elevated brachial blood pressure (mean systolic/diastolic BP: 124 ± 2/81 ± 1 mm Hg). Study participants consumed 500 mL/d of cranberry juice (~16 fl oz; 27% cranberry juice) or a matched placebo juice in a randomized order (8-week supplementation periods; 8-week compliance break), with blood samples and vascular measurements obtained at study entry and following each supplementation period. There was no significant treatment effect of cranberry juice supplementation on the primary endpoint of central systolic blood pressure or central or brachial diastolic pressure. Cranberry juice significantly reduced 24-h diastolic ambulatory BP by ~2 mm Hg compared to the placebo (p = 0.05) during daytime hours. Cranberry juice supplementation did not alter LDL-C but significantly changed the composition of the lipoprotein profile compared to the placebo, increasing the concentration of large LDL-C particles (+29.5 vs. -6.7 nmol/L; p = 0.02) and LDL size (+0.073 vs. -0.068 nm; p = 0.001). There was no effect of treatment on ex vivo HDL efflux in the total population, but exploratory subgroup analyses identified an interaction between BMI and global HDL efflux (p = 0.02), with greater effect of cranberry juice in participants who were overweight. Exploratory analyses indicate that baseline C-reactive protein (CRP) values may moderate treatment effects. In this population of adults with elevated blood pressure, cranberry juice supplementation had no significant effect on central systolic blood pressure but did have modest effects on 24-h diastolic ambulatory BP and the lipoprotein profile. Future studies are needed to verify these findings and the results of our exploratory analyses related to baseline health moderators.

Project description:BackgroundPharmacists and pharmacy assistants can support consumers by identifying minor ailments and providing evidence-based advice about treatment options. In the Netherlands, advice is based on national minor ailment guidelines and structured WWHAM questions (Who, What, How long, Action, Medication).ObjectivesTo study whether pharmacy assistants provide guideline-compliant advice for allergic rhinitis based on WWHAM and condition-specific questions (When and Familiarity) and their association with appropriate self-care advice.MethodsA retrospective study of the assessments of simulated patient (SP) visits regarding one condition- and two symptom-based cases of allergic rhinitis in Dutch community pharmacies. Pharmacies that participated in 2014, 2016 and 2018 were selected. SPs documented their observations of the problem analysis, dispensing and client interaction on a standardized scoresheet. Dispensing of an oral antihistamine according to the guideline recommendation was considered as the correct outcome. Chi-square tests were used to analyze differences in scores for problem analysis of pharmacies with correct and incorrect advice provision in 2014 and 2018. Predictors for correct outcome were identified by univariate and multivariate logistic regression analysis.ResultsData from 673 pharmacies were available for all three years. In 2014 and 2018, problems were presented as a symptom (running nose), and 41.2% and 21.1% of pharmacies dispensed an antihistamine. For the condition-based problem (allergy) in 2016, 96.0% of participating pharmacies dispensed an antihistamine. Both in 2014 and 2018, each additional problem analysis question increased the odds ratio of providing correct advice. Questions asked about 'hay fever symptoms', 'medication', 'when symptoms occurred', and 'familiar symptoms' were significant predictors of correct advice provision.ConclusionsMost pharmacies provided appropriate advice for a condition-based request but less than half of them provided appropriate advice for a symptom-based request. More questions asked was associated with an increased chance of providing correct advice. Addition of condition-specific questions may improve the WWHAM-method.

Project description:BackgroundHyperemesis gravidarum (HG) affects about 2% of pregnancies and is at the severe end of the spectrum of nausea and vomiting of pregnancy. HG causes severe maternal distress and results in adverse pregnancy outcomes long after the condition may have dissipated. Although dietary advice is a common tool in management, trial evidence to base the advice on is lacking.MethodsA randomized trial was conducted in a university hospital from May 2019 to December 2020. 128 women at their discharge following hospitalization for HG were randomized: 64 to watermelon and 64 to control arm. Women were randomized to consume watermelon and to heed the advice leaflet or to heed the dietary advice leaflet alone. A personal weighing scale and a weighing protocol were provided to all participants to take home. Primary outcomes were bodyweight change at the end of week 1 and week 2 compared to hospital discharge.ResultsWeight change (kg) at end of week 1, median[interquartile range] -0.05[-0.775 to + 0.50] vs. -0.5[-1.4 to + 0.1] P = 0.014 and to the end of week 2, + 0.25[-0.65 to + 0.975] vs. -0.5[-1.3 to + 0.2] P = 0.001 for watermelon and control arms respectively. After two weeks, HG symptoms assessed by PUQE-24 (Pregnancy-Unique Quantification of Emesis and Nausea over 24 h), appetite assessed by SNAQ (Simplified Nutritional Appetite Questionnaire), wellbeing and satisfaction with allocated intervention NRS (0-10 numerical rating scale) scores, and recommendation of allocated intervention to a friend rate were all significantly better in the watermelon arm. However, rehospitalization for HG and antiemetic usage were not significantly different.ConclusionAdding watermelon to the diet after hospital discharge for HG improves bodyweight, HG symptoms, appetite, wellbeing and satisfaction.Trial registrationThis study was registered with the center's Medical Ethics Committee (on 21/05/2019; reference number 2019327-7262) and the ISRCTN on 24/05/2019 with trial identification number: ISRCTN96125404 . First participant was recruited on 31/05/ 2019.

Dataset Information

A randomized controlled trial in Norwegian pharmacies on effects of risk alert and advice in people with elevated cardiovascular risk.

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A randomized controlled trial in Norwegian pharmacies on effects of risk alert and advice in people with elevated cardiovascular risk.

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