scholarly journals Effect of Contextualized Versus Non-Contextualized Interventions for Improving Hand Washing, Sanitation, and Health in Rural Tanzania: Study Design of a Cluster Randomized Controlled Trial

2019 ◽  
Vol 16 (14) ◽  
pp. 2529 ◽  
Author(s):  
Kim Dockx ◽  
Hans Van Remoortel ◽  
Emmy De Buck ◽  
Charlotte Schelstraete ◽  
An Vanderheyden ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Hand Washing ◽  
Control Group ◽  
Randomized Controlled ◽  
Rural Tanzania ◽  
Cluster Randomized ◽  
The Impact

Nearly 90% of diarrhea-related mortalities are the result of unsafe drinking water, poor sanitation, and insufficient hygiene. Although “Water, Sanitation, and Hygiene” (WASH) interventions may significantly reduce the risk of diarrheal disease, it is currently unclear which interventions are the most effective. In this study, we aim to determine the importance of contextualizing a WASH intervention to the local context and the needs for increasing impact (Clinicaltrials.gov NCT03709368). A total of 1500 households in rural Tanzania will participate in this cluster randomized controlled trial. Households will be randomized into one of three cohorts: (1) a control group receiving a basic intervention and 1 placebo household visit, (2) an intervention group receiving a basic intervention + 9 additional household visits which are contextualized to the setting using the RANAS approach, and (3) an intervention group receiving a basic intervention + 9 additional household visits, which are not contextualized, i.e., a general intervention. Assessments will take place at a baseline, 1 and 2 years after the start of the intervention, and 1 year after the completion of the intervention. Measurements involve questionnaires and spot checks. The primary outcome is hand-washing behavior, secondary objectives include, the impact on latrine use, health, WASH infrastructure, quality of life, and cost-effectiveness.

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 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 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 Evaluation of a Community-Based Diabetes Prevention Program in Thailand: A Cluster Randomized Controlled Trial

2019 ◽  
Vol 10 ◽  
pp. 215013271984737 ◽  
Author(s):  
Wichai Aekplakorn ◽  
Valla Tantayotai ◽  
Sakawduan Numsangkul ◽  
Nutchanat Tatsato ◽  
Pranee Luckanajantachote ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Glucose Tolerance ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Based ◽  
Randomized Controlled ◽  
Cluster Randomized

Objectives: Lifestyle interventions have been shown to effectively reduce the incidence of diabetes, but evidence from middle-income countries is scarce. We evaluated the effectiveness of a lifestyle program to prevent diabetes in primary-care settings in Thailand. Methods: A matched-pair cluster randomized controlled trial was conducted in 68 primary care units in 8 provinces. The primary care units were randomly assigned to intervention or control arms. Individuals aged 30 to 65 years with impaired oral glucose tolerance were recruited and followed up for 2 years. The intervention included periodic group-based activities on healthy lifestyle behaviors; the control group received a one-time education program. The primary outcome was the incidence rate of type 2 diabetes at 24 months after the intervention. Results: A total of 1903 individuals participated (873 in the control group and 1030 in the intervention group). At baseline, participants’ characteristics did not differ between groups. After 24 months, the incidence rates (per 100 person-year) of diabetes was 12.1% (95% CI 10.7% to 13.8%) in the intervention group, and 16.6% (95% CI 14.6 to 18.8%) in the control group ( P < .001). Overall, the adjusted hazard ratio for diabetes incidence was 0.72 (95% CI 0.60 to 0.86). A mean body weight reduction of 1.5 kg was observed in the intervention group, whereas, an increase of 0.4 kg was observed in the control group ( P < .001). Conclusion: A community-based lifestyle modification through participatory group activities can prevent or delay the incidence of diabetes among Thai populations with impaired glucose tolerance.

scholarly journals Effect of Lipid-based Nutrient Supplement - Medium Quantity on Reduction of Stunting in Children 6–23 Months of Age in Sindh, Pakistan: A Cluster Randomized Controlled Trial (OR25-06-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Sajid Soofi ◽  
Gul Nawaz ◽  
Cecilia Garzon
Keyword(s):  
Randomized Controlled Trial ◽  
Health Services ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Government Health ◽  
Randomized Controlled ◽  
Nutrient Supplement ◽  
Cluster Randomized

Abstract Objectives We evaluated the effectiveness of a locally produced lipid-based nutrient supplement - medium-quantity (LNS-MQ) known as Wawamum to prevent stunting in children 6–23 months of age in Thatta and Sujawal districts of Sindh province, Pakistan. Methods A cluster randomized controlled trial was conducted and a total of 870 children between 6–18 months old were enrolled. Children in the intervention group received 50 grams/day of Wawamum for 6 months, while children in the control group received standard government health services, not including Wawamum. The primary outcome was stunting risk reduction among children 6–23 months of age. Results Children who received Wawamum were found to have a significantly reduced risk of stunting (RR = 0.91, 95% CI; 0.88–0.94, P < 0.001) and wasting (RR = 0.78, 95% CI; 0.67–0.92, p-0.004) as compared to children who received the standard government health services. A non-significant impact was observed on underweight (RR = 0.94, 95% CI; 0.85–1.04, p-0.241) in the intervention group compared to the control group. Statistically significant reduction in anaemia in the intervention group was also found as compared to the control group (RR = 0.97, 95% CI; 0.94–0.99, p-0.008). The reduction in risk of severe anaemia was even more evident (RR = 0.45, 95% CI; 0.28–0.99, p-0.002) in the intervention group than in the control group. The mean compliance of Wawamum was 60.3% among children. Conclusions The study confirmed the plausibility of achieving nutrition gains in the short-term with a locally produced LNS-MQ, known as Wawamum, through the primary health care system. The risk of stunting and wasting was reduced by 9% and 22%, respectively. The statistically significant reduction in risk of stunting, wasting and anaemia among children 6–23 months of age showed that an immediate improvement in these nutrition indicators is indeed possible. This approach can be scaled up in similar settings to achieve positive outcomes for nutrition and health. Funding Sources World Health Organization.

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.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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 Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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