Evaluation of a community pharmacy-based intervention for improving patient adherence to antihypertensives: a randomised controlled trial

Background
The majority of patients using antihypertensive medications fail to achieve their recommended target blood pressure. Poor daily adherence with medication regimens and a lack of persistence with medication use are two of the major reasons for failure to reach target blood pressure. There is no single intervention to improve adherence with antihypertensives that is consistently effective. Community pharmacists are in an ideal position to promote adherence to chronic medications. This study aims to test a specific intervention package that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and/or persistence with antihypertensive medications - Hypertension Adherence Program in Pharmacy (HAPPY).

Methods/Design
The HAPPY trial is a multi-centre prospective randomised controlled trial. Fifty-six pharmacies have been recruited from three Australian states. To identify potential patients, a software application (MedeMine CVD) extracted data from a community pharmacy dispensing software system (FRED Dispense®). The pharmacies have been randomised to either 'Pharmacist Care Group' (PCG) or 'Usual Care Group' (UCG). To check for 'Hawthorne effect' in the UCG, a third group of patients 'Hidden Control Group' (HCG) will be identified in the UCG pharmacies, which will be made known to the pharmacists at the end of six months. Each study group requires 182 patients. Data will be collected at baseline, three and six months in the PCG and at baseline and six months in the UCG. Changes in patient adherence and persistence at the end of six months will be measured using the self-reported Morisky score, the Tool for Adherence Behaviour Screening and medication refill data.

Discussion
To our knowledge, this is the first research testing a comprehensive package of evidence-based interventions that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and/or persistence with antihypertensive medications. The unique features of the HAPPY trial include the use of MedeMine CVD to identify patients who could potentially benefit from the service, control for the 'Hawthorne effect' in the UCG and the offer of the intervention package at the end of six months to patients in the UCG, a strategy that is expected to improve retention.

Trial Registration
Australian New Zealand Clinical Trial Registry ACTRN12609000705280

Twelve-month effects of a playground intervention on children's morning and lunchtime recess physical activity levels

Background: Recess is an opportunity for children to engage in daily physical activity. The aim of this study was to investigate the 12-month effects of a playground intervention on children’s moderate-to-vigorous (MVPA) and vigorous physical activity (VPA) during morning and lunchtime recess.

Methods: Four hundred and seventy children (232 boys, 238 girls) from 26 elementary schools participated in the study. Fifteen schools redesigned the playground environment using playground markings and physical structures. Eleven schools served as socioeconomic matched controls. Physical activity levels were quantified using heart rate and accelerometry at baseline, 6 months, and 12 months post-intervention. A 3-level (time, pupil, and school) multilevel analysis was used to determine the effects of the intervention across time on MVPA and VPA.

Results: Positive yet nonsignificant intervention effects were found for MVPA and VPA during morning and lunchtime recess. Intervention children were more active during recess than control children. Interactions revealed that the intervention effect was stronger at 6 months than 12 months post-intervention.

Conclusions: A playground markings and physical structures intervention had a positive effect on intervention children’s morning and lunchtime MVPA and VPA when assessed using heart rate and accelerometry, but this effect is strongest 6-months post-intervention and decreased between 6 months and 12 months.

Children's physical activity levels during school recess : a quasi-experimental intervention study

Background : Recess provides a daily opportunity for children to engage in moderate-to-vigorous (MVPA) and vigorous physical activity (VPA). Limited research has investigated the effects of recess-based interventions on physical activity using large sample sizes whilst investigating variables that may influence the intervention effect. The aim of the study was to investigate the short-term effects of a playground markings and physical structures intervention on recess physical activity. A secondary aim was to investigate the effects of covariates on the intervention.

Methods : 150 boys and 147 girls were randomly selected from 26 elementary schools to wear uni-axial accelerometers that quantified physical activity every 5 seconds during recess. Fifteen schools located in deprived areas in one large urban city in England received funding through a national initiative to redesign the playground environment. Eleven schools served as matched socioeconomic controls. Data were collected at baseline and 6-weeks following playground intervention. Recess MVPA and VPA levels adjusted for pupil- and school-level covariates (baseline physical activity, age, gender, recess length, body mass index) were analysed using multilevel analyses.

Results : Positive but non-significant intervention effects were found for MVPA and VPA when confounding variables were added to the model. Gender was a significant predictor of recess physical activity, with boys engaging in more MVPA and VPA than girls. Significant interactions for MVPA revealed that the intervention effect was stronger for younger elementary aged school children compared to older children, and the intervention effect increased as daily recess duration increased.

Conclusion : The playground redesign intervention resulted in small but non-significant increases in children's recess physical activity when school and pupil level variables were added to the analyses. Changing the playground environment produced a stronger intervention effect for younger children, and longer daily recess duration enabled children to engage in more MVPA following the intervention. This study concludes that the process of increasing recess physical activity is complex when school and pupil-level covariates are considered, though they should be taken into account when investigating the effects of playground intervention studies on children's physical activity during recess.

Does family intervention for adolescent substance use impact parental wellbeing?

Adolescent substance abuse is a prevalent problem and family interventions are increasingly used to prevent this problem and to assist family coping. The effectiveness of a prevention-focussed family intervention was evaluated within a randomised school trial for its secondary impacts on improving parental mental health and family functioning.

The effect of folic acid supplementation on dna biomarkers of colorectal cancer risk (uracil misincorporation, global and gene-specific dna hypomethylation) : a randomised intervention study

Background - Alterations in folate status are associated with colorectal carcinogenesis. Folate’s role has been postulated to be either via prevention of changes in DNA methylation or uracil misincorporation.
Objective - To investigate the effect of folic acid supplementation on colonocyte folate status and DNA biomarkers.
Design - Twenty individuals harbouring colonic adenomas were randomised to receive folic acid (600 g daily) or placebo for 6 months post polypectomy. Systemic and colonocyte folate status was determined at baseline and following the intervention. Modified Comet assays were used to determine uracil misincorporation and global DNA hypomethylation at the site adjacent to the polyp and a site distal to the polyp.
Outcomes - Supplementation resulted in increased colonocyte folate, which approached significance, at the site adjacent to the polyp (P= 0.06) but not distal to the polyp (P= 0.36); correspondingly there was a reduction in uracil misincorporation at the site adjacent to the polyp (P = 0.02) and the distal site showed no such trend (P= 0.39). There were no significant changes in global DNA hypomethylation at either site post-intervention.
Conclusions - Folic acid supplementation resulted in increased colonocyte folate and decreased uracil misincorporation at the site of the adenoma but not distal to the adenoma. This supports the hypothesis that localised areas of folate deficiency may exist in human colonic mucosa which respond to folic acid supplementation through increasing colonocyte folate and improving folate-related DNA biomarkers of cancer risk.

A family-based intervention to increase fruit and vegetable consumption in adolescents : a pilot study

Objective: To evaluate the feasibility and effectiveness of a pilot family-based newsletter intervention to increase fruit and vegetable (FV) consumption among adolescents.
Design: Family-based, two-group randomised control trial with baseline, postintervention and follow-up measures. The intervention group received two FV newsletter packs over a 1 month period by postal mail. Social cognitive and behavioural choice theories provide the theoretical framework for the design and development of intervention materials. Control families were provided with all intervention materials at the end of the study. Adolescent FV consumption was assessed by an FFQ. Adolescent-reported barriers to eating FV, FV habits and preferences were the secondary outcomes, along with parent FV consumption, and parents reported knowledge, encouragement, home availability and accessibility of FV. Repeated-measures ANOVA was used to detect differences in behavioural and psychosocial outcomes between groups, time and group-by-time.
Setting: East Midlands, UK.
Subjects: Forty-nine parents and adolescents aged 12–14 years.
Results: Process evaluation indicated high reach, dose acceptability and fidelity of the intervention. At post-intervention and 6 weeks later at follow-up, adolescents in the intervention group had significantly higher fruit: (P0<·01) and vegetable (P<0·05) consumption and higher preferences for vegetables (P<0·01), compared with the control group. At post-intervention and follow-up, parents in the intervention group had significantly higher fruit (P<0·001) and vegetable (P<0·01) consumption and reported higher accessibility of fruit and vegetables (P<0·001), compared with those in the control group.
Conclusions: Family-based, newsletter interventions promoting FV consumption to adolescents appear to be feasible and effective at increasing FV consumption.