Evaluation of the ‘H2NOE Water Schools’ programme to promote water consumption in elementary school children – a non-randomised controlled cluster trial

Objective: This study evaluated a simple environmental intervention called ‘Water Schools’ in Lower Austria providing free refillable water bottles and educational material. Design: Non-randomised controlled cluster trial with three measurements: at baseline (T0), after the intervention at 9 months (T1), after one-year follow-up (T2). Setting: Half-day elementary schools in Lower Austria (Austria). Participants: Third-grade pupils from 22 schools in the intervention group (IG) and 32 schools in the control group (CG) participated in the study. Data were analysed for 569 to 598 pupils in the IG and for 545 to 613 in the CG, depending on the time of measurement. Results: The consumption of tap water increased in the IG from baseline to T1 and then decreased again at T2, but this was similar in the CG (no statistically significant difference in the time trend between the IG and CG). Similar results were seen for tap water consumption in the mornings. The proportion of children who only drank tap water on school mornings increased significantly from baseline to T1 in the IG compared to the CG (p=0.020). No difference in the changes over time occurred between the groups for the proportion of pupils drinking approximately one bottle of tap water during school mornings. Conclusions: Not only the children in the IG but also those in the CG drank more tap water after 1 school year than at the beginning. The measurement of drinking habits in the CG may have been intervention enough to bring about changes or to initiate projects.

Improving access to medicines for non-communicable diseases in rural primary care: results from a quasi-randomized cluster trial in a district in South India

Background A large proportion of non-communicable diseases (NCDs) are treatable within primary health care (PHC) settings in a cost-effective manner. However, the utilization of PHCs for NCD care is comparatively low in India. The Access-to-Medicines (ATM) study examined whether (and how) interventions aimed at health service optimization alone or combined with community platform strengthening improve access to medicines at the primary health care level within the context of a local health system. Method A quasi-randomized cluster trial was used to assess the effectiveness of the intervention (18 months) implemented across 39 rural PHCs (clusters) of three sub-districts of Tumkur in southern India. The intervention was allocated randomly in a 1:1:1 sequence across PHCs and consisted of three arms: Arm A with a package of interventions aimed at health service delivery optimization; B for strengthening community platforms in addition to A; and the control arm. Group allocation was not blinded to providers and those who assessed outcomes. A household survey was used to understand health-seeking behaviour, access and out-of-pocket expenditure (OOP) on key anti-diabetic and anti-hypertension medicines among patients; facility surveys were used to assess the availability of medicines at PHCs. Primary outcomes of the study are the mean number of days of availability of antidiabetic and antihypertensive medicines at PHCs, the mean number of patients obtaining medicines from PHC and OOP expenses. Result The difference-in-difference estimate shows a statistically insignificant increase of 31.5 and 11.9 in mean days for diabetes and hypertension medicines availability respectively in the study arm A PHCs beyond the increase in the control arm. We further found that there was a statistically insignificant increase of 2.2 and 3.8 percentage points in the mean proportion of patients obtaining medicines from PHC in arm A and arm B respectively, beyond the increase in the control arm. Conclusion There were improvements in NCD medicine availability across PHCs, the number of patients accessing PHCs and reduction in OOP expenditure among patients, across the study arms as compared to the control arm; however, these differences were not statistically significant. Trial registration Trial registration number CTRI/2015/03/005640. This trial was registered on 17/03/2015 in the Clinical Trial Registry of India (CTRI) after PHCs were enrolled in the study (retrospectively registered). The CTRI is the nodal agency of the Indian Council of Medical Research for registration of all clinical, experimental, field intervention and observation studies.

Improving Bereavement Outcomes in Zimbabwe: Results of a Feasibility Cluster Trial of the 9-Cell Bereavement Tool

ContextDespite high mortality rates from both communicable and non-communicable diseases, bereavement studies are under-researched in African countries. The 9-cell bereavement tool was designed to assist individuals to reflect on their feelings in bereavement, and identify resources in families and communities to manage bereavement. This study aimed to determine the feasibility of implementing the 9-cell bereavement tool and recruitment to experimental evaluation. Methods: A feasibility cluster randomized trial with embedded qualitative interviews was conducted in two comparable neighborhoods in Chitungwiza, Zimbabwe. Community leaders identified potential community lay bereavement supporters (interventionists). Each recruited 2-3 recently bereaved community members (trial participants). Following baseline data collection, the communities were randomly allocated to intervention or wait-list control. Self-administered questionnaires were completed at T0 (month 0), T1(3 months) and T2 (6 months). Grief, mental health and social support were assessed. Focus group discussions with selected interventionists described training impact and intervention processes. Quantitative and qualitative analysis were performed. ResultsObjectives were achieved as follows(i) feasibility of recruitment and retention (ii) feasibility of implementing the intervention (iii) determining contamination(iv) completeness of data(v) participants’ views on intervention and mechanisms(vi) estimating potential effect size (vii) determining whether full trial warranted. In line with the aim of the study, the processes of the randomized cluster trial were possible. We successfully conducted the randomized control trial of the 9-cell bereavement tool and successfully recruited study participants. In addition, the 9-cell intervention allowed interventionists to share and learn from their grieving process. All of the above was conducted within the intended timeframe of 3 weeks, with an over recruitment of 112% of interventionists and 43% more trial participants. This means we were able to recruit at least 75% of the suggested sample size; and to retain at least 75% of the trial participants for the total duration of the study. Conclusion The processes of the randomized controlled trial were possible. The 9-cell bereavement intervention was delivered and process data assessed. The study was funded through the BuildCARE fund from the Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation Protocol Registration: http://www.isrctn.com/ISRCTN16484746.Protocol Publication: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0450-5

Feasibility Study of an Educational Intervention to Improve Water Intake in Adolescent Soccer Players: A Two-Arm, Non-Randomized Controlled Cluster Trial

This study aimed to assess the feasibility of an educational intervention on hydration behavior in adolescent soccer players. A pilot study of a two-arm, non-randomized controlled cluster trial was conducted. A total of 316 players aged 13–16 agreed to participate. The response variables were the players’ participation in the intervention, their perception of the knowledge acquired, the usefulness and the overall assessment of the intervention. Hydration patterns and acquisition of knowledge on hydration behavior were also assessed. The intervention involved two elements: posters and a web app. A total of 259 adolescents completed the study (intervention group (IG) = 131; control group (CG) = 128). 80.6% of the players responded to the survey assessing the feasibility of the intervention. The mean number of correct answers regarding behavior was significantly higher in the IG (3.54; SD = 1.162) than in the CG (2.64; SD = 1.174) (p < 0.001). The water consumption pattern at all the clubs was ad libitum. Of the players, 10% did not drink any water at all during the game. In conclusion, this intervention has been shown to be feasible for implementation with adolescent soccer players. It suggests that hydration guidelines should be informed by personal factors and that ad libitum water consumption should be avoided.

Feasibility of implementation of CARD™ for school-based immunizations in Calgary, Alberta: a cluster trial

Background Negative experiences with school-based immunizations can contribute to vaccine hesitancy in youth and adulthood. We developed an evidence-based, multifaceted and customizable intervention to improve the immunization experience at school called the CARD™ (C-Comfort, A-Ask, R-Relax, D-Distract) system. We evaluated the feasibility of CARD™ implementation for school-based immunizations in Calgary, Canada. Methods In a mixed methods study, two Community Health Centres providing immunization services, including 5 schools each with grade 9 students (aged approximately 14 years), were randomized to CARD™ or control (usual care). In the CARD™ group, public health staff and students were educated about coping strategies prior to immunization clinics. Clinics were organized to reduce fear and to support student’s choices for coping strategies. Public health staff in the CARD™ group participated in a focus group discussion afterwards. We sought a recruitment rate of 80% for eligible schools, an external stakeholder focus group (e.g., school staff) with 6 or more individuals, 85% of individual injection-related data acquisition (student and immunizer surveys), and 80% absolute agreement between raters for a subset of data that were double-coded. Across focus groups, we examined perceptions of acceptability, appropriateness, feasibility and fidelity of CARD™. Results Nine (90%) of eligible schools participated. Of 219 students immunized, injection-related student and immunizer data forms were acquired for 195 (89.0%) and 196 (89.5%), respectively. Reliability of data collection was high. Fifteen public health and 5 school staff participated in separate focus groups. Overall, attitudes towards CARD™ were positive and compliance with individual components of CARD™ was high. Public health staff expressed skepticism regarding the value of student participation in the CARD™ system. Suggestions were made regarding processes to refine implementation. Conclusion While most outcome criteria were satisfied and overall perceptions of implementation outcomes were positive, some important challenges and opportunities were identified. Feedback is being used to inform a large cluster trial that will evaluate the impact of CARD™ during school-based immunizations. Trial registration The trial is registered at ClinicalTrials.gov (NCT03948633); Submitted April 24, 2019.

Nasal irrigation and gargling with hypertonic saline to prevent transmission of Sars-CoV-2 to care home residents – a feasibility cluster trial

Hypertonic saline nasal irrigation and gargling (HSNIG) has the potential to reduce COVID 19 transmission. We present a pilot cluster randomised controlled trial to assess the feasibility and acceptability of a future trial to test the effectiveness of HSNIG in care homes (CHs). Staff in the intervention CHs were invited to perform HSNIG whereas control CHs carried on with their routine protection procedures. The acceptability of HSNIG was explored via interviews and online surveys. Seven (21%) of contacted CHs participated but following randomisation three (43%) dropped out leaving two intervention CHs and two control CHs. Facilitators to uptake of HSNIG included motivated ‘champions’ and integration into routines. Barriers included a lack of ownership and perceptions of reduced risk from COVID-19. Recruiting and retaining CHs in this study was challenging. Although HSNIG was reported to be safe and acceptable by staff, further work is required to quantify and optimise its acceptability.