scholarly journals The Effect of Oral Health Promotion Program on Early Dental Decay in Students: a Cluster Randomized Controlled Trial

2019 ◽  
Vol 8 (2) ◽  
pp. 105-110 ◽  
Author(s):  
Vahid Naseri Salahshour ◽  
Hamid Abredari ◽  
Mahbobeh Sajadi ◽  
Masoumeh Sabzaligol ◽  
Mahmood Karimy
Keyword(s):  
Randomized Controlled Trial ◽  
Elementary Students ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Oral Health Promotion ◽  
Dental Decay ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Cluster Randomized

Introduction: The use of different models play a significant role in health education and its promotion. Therefore, the present study aims to investigate the effect of the Theory of Planned Behavior (TPB) on early dental decay in elementary students. Methods: This study was a single-blinded, cluster randomized controlled trial, in which 470 elementary students in the fourth, fifth and sixth grades in Saveh, Iran were participated. A demographic questionnaire and a 5-item questionnaire consisting of questions on awareness, attitude, practice, tooth brushing, diet and referring to dentist, were used to data collection. The samples of the intervention (n=234) and control (n=236) groups filled out the questionnaires before intervention (pre-test), immediately after intervention and one month after intervention. The educational intervention based on the TPB was held in three 45-minute sessions. Finally, the data were analyzed, using the SPSS version 13. For analyzing, the Independent t-test, Chi-square, and repeated measures ANOVA were used. Results: This study showed that there is a significant difference in the mean scores obtained from knowledge, attitude, subjective norm, perceived behavioral control, behavioral intention and behavior among students in the experimental group (immediately after and one month after the intervention) and students in the control group. Conclusion: The results of this study showed that using of TPB, as a framework for providing behavior-led training, can be effective in promoting oral and dental health of students. Nurses as an important member of the treatment team can use the results of this study in school health programs.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

scholarly journals Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Isabella Bablok ◽  
◽  
Harald Binder ◽  
Dominikus Stelzer ◽  
Klaus Kaier ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Dementia Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Care Model ◽  
Randomized Controlled ◽  
Individual Needs ◽  
Cluster Randomized ◽  
The Individual

Abstract Background Most people with dementia (PwD) are cared for at home, with general practitioners (GPs) playing a key part in the treatment. However, primary dementia care suffers from a number of shortcomings: Often, diagnoses are made too late and therapies by GPs do not follow the guidelines. In cases of acute crises, PwD are too often admitted to hospital with adverse effects on the further course of the disease. The aim of this study is to implement and evaluate a new GP-based, complex dementia care model, DemStepCare. DemStepCare aims to ensure demand-oriented, stepped care for PwD and their caregivers. Methods/design In a cluster randomized controlled trial, the care of PwD receiving a complex intervention, where the GP is supported by a multi-professional team, is compared to (slightly expanded) usual care. GPs are clustered by GP practice, with 120 GP practices participating in total. GP practices are randomized to an intervention or a control group. 800 PwD are to be included per group. Recruitment takes place in Rhineland-Palatinate, Germany. In addition, a second control group with at least 800 PwD will be formed using aggregated routine data from German health insurance companies. The intervention comprises the training of GPs, case management including repeated risk assessment of the patients’ care situation, the demand-oriented service of an outpatient clinic, an electronic case record, external medication analyses and a link to regional support services. The primary aims of the intervention are to positively influence the quality of life for PwD, to reduce the caregivers’ burden, and to reduce the days spent in hospital. Secondary endpoints address medication adequacy and GPs’ attitudes and sensitivity towards dementia, among others. Discussion The GP-based dementia care model DemStepCare is intended to combine a number of promising interventions to provide a complex, stepped intervention that follows the individual needs of PwD and their caregivers. Its effectiveness and feasibility will be assessed in a formative and a summative evaluation. Trial registration German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560. Registered 13 November 2020 - Retrospectively registered. HTML&TRIAL_ID=DRKS00023560.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals Infectious Disease Team Review Using Antibiotic Switch and Discharge Criteria Shortens the Duration of Intravenous Antibiotic: A Single-Center Cluster-Randomized Controlled Trial in Thailand

2020 ◽  
Vol 7 (12) ◽  
Author(s):  
Thanyarak Wongkamhla ◽  
Buddharat Khan-asa ◽  
Sasima Tongsai ◽  
Nasikarn Angkasekwinai
Keyword(s):  
Infectious Disease ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Defined Daily Dose ◽  
Randomized Controlled ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Cluster Randomized ◽  
Discharge Criteria

Abstract Background Strategies have been recommended to optimize early antibiotic (ATB) switching from intravenous (IV) to oral ATB. This study aimed to determine whether infectious disease (ID) team review using ATB switch and discharge criteria would shorten the duration of IV ATB and length of hospital stay (LOS). Methods This cluster-randomized controlled trial was conducted in 8 general medical wards as cluster units at Siriraj Hospital during January–October 2019. The ID team review with checklist criteria was performed on the third, fifth, and seventh day of IV-ATB treatment to determine (1) the suitability of switching to oral ATB or outpatient parenteral ATB therapy and (2) early discharge for patients receiving IV-ATB versus control. The primary outcomes were LOS and the duration or days of therapy (DOT) or defined daily dose (DDD) of IV-ATB therapy. Results Four wards each were randomly assigned to the intervention and control groups (46 patients/cluster, 184 patients/arm). No significant difference was observed between intervention and controls for median duration of IV-ATB therapy (7 vs 7 days) and LOS (9 vs 10 days). A significantly shorter duration of IV ATB was observed in patients without sepsis in the intervention group when measured by DOT (7 vs 8 days, P = .027) and DDD (7 vs 9, P = .017) in post hoc analysis. Conclusions Infectious disease team review using checklist criteria did not result in a shorter duration of IV-ATB and LOS in overall patients. Further study is needed to determine whether faster culture turnaround time or advanced testing will reduce the duration of IV-ATB therapy.

scholarly journals A Cluster Randomized Controlled Trial Feasibility Study of a WhatsApp-Delivered Intervention to Promote Healthy Eating Habits in Male Firefighters

2021 ◽  
Vol 18 (12) ◽  
pp. 6633
Author(s):  
Winnie Wing Man Ng ◽  
Anthony Siu Wo Wong ◽  
Kin Cheung
Keyword(s):  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Eating Habits ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Healthy Eating Habits ◽  
Cluster Randomized

This cluster randomized controlled trial (CRCT)-designed study aimed to explore the feasibility of a promotion pamphlet and/or WhatsApp as a suitable mode of delivery to promote healthy eating habits with fruit and vegetables (F&V) among firefighters. Convenience and snowball sampling methods were used. Forty-five firefighters from 23 fire stations were recruited and they all received the printed pamphlet, while the intervention group participants (n = 20) received additional teaching material through WhatsApp every two weeks for eight weeks. Feasibility outcomes included retention, practicality, and implementation. The participants reported high levels of satisfaction with the intervention. There were significant improvements in the mean numbers of days consuming F&V (p = 0.002; p = 0.031) in the intervention group, and for fruit consumption (p = 0.033) in the control group between the baseline (T0) and 3 months after completion of intervention (T1). High levels of participants’ satisfaction with the intervention revealed that a full-scale CRCT of the WhatsApp-delivered intervention promoting healthy eating could be feasible, especially as a means of increasing the numbers of days they consumed F&V and the numbers of servings of these consumed per day.

scholarly journals The effectiveness of an interactive organ donation education intervention for Dutch lower-educated students: a cluster randomized controlled trial

2019 ◽  
Author(s):  
Esther Steenaart ◽  
Rik Crutzen ◽  
Math JJM Candel ◽  
Nanne K de Vries
Keyword(s):  
Randomized Controlled Trial ◽  
Organ Donation ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Post Test ◽  
Cluster Randomized ◽  
And Control ◽  
Experimental Group

Abstract Background: Organ donation registration rates remain low, especially among people with lower educational levels. An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation. This article reports on the effects of this intervention on the intention to register (i.e. the primary outcome in the study at hand) and beliefs regarding organ donation. Methods: The effectiveness was investigated in a post-test only cluster randomized controlled trial, in which the intervention was offered to the experimental group and after measurement also to the control group. Randomization to the experimental and control groups took place at a class level. Teachers of schools for intermediate vocational education who taught a course on Citizenship delivered three intervention elements (i.e. video fragments and discussion, quizzes with tailored feedback and exercise filling out a registration form) to their students during two 50-minute lessons. Results: A total of 1170 students participated in the trial and filled out a questionnaire (45 experimental and 43 control classes). Compared to the control group, students in the experimental group had higher odds of having positive registration intentions (OR=1.81; 95%CI [1.10-2.96]), their perceived knowledge was higher (B=.62; 95%CI [.23-1.01]) and they had higher intentions to talk to family members (B=.68; 95%CI [.28-1.08]) and friends (B=.36; 95%CI [.07-.66]) about organ donation. There were no effects on the choice students intended to register (OR=1.08; 95%CI [.67-1.73]). Conclusions: Providing education in a classroom setting is an effective tool in increasing registration intentions. Despite uncertainties about the effects on actual registration behavior, a larger scale dissemination of this intervention is recommended. Providing clear information and opening the discussion about organ donation is an important and promising first step towards higher registration rates. Trial registration: The Dutch Trial Register, NTR6771. Registered on 24 October 2017. https://www.trialregister.nl/trial/6557

scholarly journals Effectiveness of unconditional cash transfers combined with lipid-based nutrient supplement and/or behavior change communication to prevent stunting among children in Pakistan: a cluster randomized controlled trial

2021 ◽  
Author(s):  
Sajid Bashir Soofi ◽  
Shabina Ariff ◽  
Gul Nawaz Khan ◽  
Atif Habib ◽  
Sumra Kureishy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Behavior Change Communication ◽  
Randomized Controlled ◽  
Change Communication ◽  
Nutrient Supplement ◽  
Significant Difference ◽  
Cluster Randomized

Abstract Background In Pakistan, the prevalence of stunting among children under-five years has remained above WHO critical thresholds (≥30%) over the last two decades. Objective We hypothesized that an unconditional cash transfer (UCT) combined with lipid-based nutrient supplement (LNS) and/or social and behavior change communication (SBCC) will prevent stunting among children 6-23 months of age. Design This was a four-arm, community-based cluster randomized controlled trial conducted in the district of Rahim Yar Khan, Pakistan. A total of 1729 children (UCT n = 434); (UCT+SBCC n = 433); (UCT+LNS n = 430) and (UCT+LNS+SBCC n = 432) were enrolled at 6 months of age and measured monthly for 18 months until the age of 24 months. Results At 24 months of age, children who received UCT+LNS (rate ratio [RR], 0.85 [95% CI 0.74, 0.97]; P = 0.015); and UCT+LNS+SBCC (RR, 0.86 [95% CI 0.77, 0.96]; P = 0.007) had significantly lower risk of being stunted as compared to the UCT arm. No significant difference was noted among children who received UCT+SBCC (RR, 1.03 [95% CI 0.91, 1.16]; P = 0.675) in the risk of being stunted as compared to the UCT arm. The pooled prevalence of stunting among children 6-23 months was 41.7%, 44.8%, 38.5% and 39.3% in UCT, UCT+SBCC, UCT+LNS and UCT+LNS+SBCC, respectively. In pairwise comparisons, a significant impact on stunting among children in UCT+LNS (P = 0.029) and UCT+LNS+SBCC (P = &lt;0.001) was noted as compared to UCT arm. Conclusions UCT combined with LNS and UCT+LNS+SBCC were effective in reducing the prevalence of stunting among children aged 6-23 months in marginalized populations. UCT+SBCC was not effective in reducing the child stunting prevalence. Clinical trial registration number: ClinicalTrials.gov NCT03299218

scholarly journals The Impact of Shorter, More Frequent Outdoor Play Periods on Preschoolers’ Physical Activity during Childcare: A Cluster Randomized Controlled Trial

2019 ◽  
Vol 16 (21) ◽  
pp. 4126 ◽  
Author(s):  
Molly Driediger ◽  
Stephanie Truelove ◽  
Andrew M. Johnson ◽  
Leigh M. Vanderloo ◽  
Brian W. Timmons ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Outdoor Play ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Children’s physical activity levels are higher at the start of outdoor playtime, which suggests that shorter, more frequent play periods might result in greater amounts of daily physical activity. In this extension of the Supporting Physical Activity in the Childcare Environment (SPACE) cluster randomized controlled trial, we explored the impact of four 30-min daily outdoor unstructured play periods on preschoolers’ moderate-to-vigorous-intensity physical activity (MVPA). Experimental childcare centres (n = 6) implemented four 30-min daily outdoor playtimes for 8 weeks, while control centres (n = 6) maintained their two 60-min outdoor sessions. Actical™ accelerometers were used to measure preschoolers’ physical activity pre- and post-intervention for 5 days during childcare hours. Linear mixed effects models were used to determine the impact of the intervention on preschoolers’ MVPA. Of the 185 preschoolers enrolled (54.20% female; mean age = 39.90 months, SD = 7.24), 127 (65 experimental and 62 control) were included in the analysis (30% and 9% loss to follow-up for experimental and control group preschoolers, respectively). No significant differences in MVPA were observed between groups over time (p = 0.36). Preschoolers’ MVPA did not improve after the introduction of shorter outdoor play periods. The loss of data due to wear time noncompliance and participant attrition may have influenced these findings. Trial registration: ISRCTN70604107 (October 8, 2014).

scholarly journals A Cluster Randomized Controlled Trial Evaluating the Impact of Tailored Feedback on the Purchase of Healthier Foods from Primary School Online Canteens

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2405
Author(s):  
Fiona Stacey ◽  
Tessa Delaney ◽  
Kylie Ball ◽  
Rachel Zoetemeyer ◽  
Christophe Lecathelinais ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Schools ◽  
Controlled Trial ◽  
Saturated Fat ◽  
Sodium Content ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Cluster Randomized ◽  
The Impact

Few online food ordering systems provide tailored dietary feedback to consumers, despite suggested benefits. The study aim was to determine the effect of providing tailored feedback on the healthiness of students’ lunch orders from a school canteen online ordering system. A cluster randomized controlled trial with ten government primary schools in New South Wales, Australia was conducted. Consenting schools that used an online canteen provider (‘Flexischools’) were randomized to either: a graph and prompt showing the proportion of ‘everyday’ foods selected or a standard online ordering system. Students with an online lunch order during baseline data collection were included (n = 2200 students; n = 7604 orders). Primary outcomes were the proportion of foods classified as ‘everyday’ or ‘caution’. Secondary outcomes included: mean energy, saturated fat, sugar, and sodium content. There was no difference over time between groups on the proportion of ‘everyday’ (OR 0.99; p = 0.88) or ‘caution’ items purchased (OR 1.17; p = 0.45). There was a significant difference between groups for average energy content (mean difference 51 kJ; p−0.02), with both groups decreasing. There was no difference in the saturated fat, sugar, or sodium content. Tailored feedback did not impact the proportion of ‘everyday’ or ‘caution’ foods or the nutritional quality of online canteen orders. Future research should explore whether additional strategies and specific feedback formats can promote healthy purchasing decisions.

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