scholarly journals Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare trial): study protocol for a stepped-wedge cluster randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Carina King ◽  
Malini Pires ◽  
Naveed Ahmed ◽  
Kohenour Akter ◽  
Abdul Kuddus ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Stepped Wedge ◽  
Community Based ◽  
Participatory Learning ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
And Control

Abstract Background An estimated 463 million people globally have diabetes, with the prevalence growing in low-and middle-income settings, such as Bangladesh. Given the need for context-appropriate interventions to prevent type 2 diabetes mellitus (T2DM), the ‘Diabetes: Community-led Awareness, Response and Evaluation’ (D:Clare) trial will rigorously evaluate the replication and scale-up of a participatory learning and action (PLA) cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. Methods This is a stepped-wedge cluster randomised controlled trial, with integrated process and economic evaluations, conducted from March 2020 to September 2022. The trial will evaluate a community-based four-phase PLA cycle intervention focused on prevention and control of T2DM implemented over 18 months, against a control of usual care. Twelve clusters will be randomly allocated (1:1) to implement the intervention at project month 1 or 12. The intervention will be evaluated through three cross-sectional surveys at months 1, 12 and 24. The trial will be conducted in Alfadanga Upazila, Faridpur district, with an estimated population of 120,000. Clusters are defined as administrative geographical areas, with approximately equal populations. Each of the six unions in Alfadanga will be divided into two clusters, forming 12 clusters in total. Given the risk of inter-cluster contamination, evaluation surveys will exclude villages in border areas. Participants will be randomly sampled, independently for each survey, from a population census conducted in January 2020. The primary outcome is the combined prevalence of intermediate hyperglycaemia and T2DM, measured through fasting and 2-h post-glucose load blood tests. A total of 4680 participants provide 84% power to detect a 30% reduction in the primary outcome, assuming a baseline of 30% and an ICC of 0.07. The analysis will be by intention-to-treat, comparing intervention and control periods across all clusters, adjusting for geographical clustering. Discussion This study will provide further evidence of effectiveness for community-based PLA to prevent T2DM at scale in a rural Bangladesh setting. However, we encountered several challenges in applying the stepped-wedge design to our research context, with particular consideration given to balancing seasonality, timing and number of steps and estimation of partial versus full effect. Trial registration ISRCTN: ISRCTN42219712. Registered on 31 October 2019

scholarly journals Community Participatory Learning and Action Cycle Groups to Reduce Type 2 Diabetes in Bangladesh (DClare): Study Protocol for a Stepped-Wedge Cluster Randomised Controlled Trial

2021 ◽  
Author(s):  
Carina King ◽  
Malini Pires ◽  
Naveed Ahmed ◽  
Kohenour Akter ◽  
Abdul Kuddus ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Stepped Wedge ◽  
Community Based ◽  
Participatory Learning ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
And Control

Abstract BackgroundAn estimated 463 million people globally have diabetes, with the prevalence growing in low-and middle-income settings, such as Bangladesh. Given the need for context appropriate interventions to prevent type 2 diabetes mellitus (T2DM), the “Diabetes: Community-led Awareness, Response and Evaluation” (D:Clare) trial will rigorously evaluate the replication and scale-up of a participatory learning and action (PLA) cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. MethodsThis is a stepped-wedge cluster randomised controlled trial, with integrated process and economic evaluations, conducted from March 2020 – September 2022. The trial will evaluate a community-based four-phase PLA cycle intervention focused on prevention and control of T2DM implemented over 18-months, against a control of usual care. Twelve clusters will be randomly allocated (1:1) to implement the intervention at project month 1 or 12. The intervention will be evaluated through three cross-sectional surveys at months 1, 12 and 24. The trial will be conducted in Alfadanga upazila, Faridpur district, with an estimated population of 120,000. Clusters are defined as administrative geographical areas, with approximately equal populations. Each of the six unions in Alfadanga will be divided into two clusters, forming 12 clusters in total. Given the risk of inter-cluster contamination, evaluation surveys will exclude villages in border areas. Participants will be randomly sampled, independently for each survey, from a population census conducted in January 2020. The primary outcome is the combined prevalence of intermediate hyperglycaemia and T2DM, measured through fasting and 2-hour post glucose load blood tests. A total of 4680 participants provides 84% power to detect a 30% reduction in the primary outcome, assuming a baseline of 30% and ICC of 0.07. Analysis will be by intention-to-treat, comparing intervention and control periods across all clusters, adjusting for geographical clustering. DiscussionThis study will provide further evidence of effectiveness for community-based PLA to prevent T2DM at scale in a rural Bangladesh setting. However, we encountered several challenges in applying the step-wedged design to our research context, with particular consideration given to balancing seasonality, timing and number of steps and estimation of partial versus full effect. Trial registrationISRCTN42219712 (https://doi.org/10.1186/ISRCTN42219712). Registration date: 31/10/2019.

scholarly journals Effect of a community-based intervention for cardiovascular risk factor control on stroke mortality in rural Gadchiroli, India: study protocol for a cluster randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yogeshwar Kalkonde ◽  
Mahesh Deshmukh ◽  
Sindhu Nila ◽  
Sunil Jadhao ◽  
Abhay Bang
Keyword(s):  
Randomised Controlled Trial ◽  
Prevention And Control ◽  
Preventive Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Stroke Mortality ◽  
Community Based ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
And Control

Abstract Background Stroke has emerged as a leading cause of death in rural India. However, well-tested healthcare interventions to reduce stroke mortality in rural under-resourced settings are lacking. The aim of this study is to evaluate the effect of a community-based preventive intervention on stroke mortality in rural Gadchiroli, India. Methods The study is a two-arm, parallel group, cluster randomised controlled trial in which 32 villages will be randomised to the intervention and the enhanced usual care (EUC) arm. In the intervention arm, individuals ≥50 years of age will be screened for hypertension, diabetes and stroke by trained Community Health Workers (CHWs). Screened individuals who are positive will be referred to a mobile outreach clinic which will visit the intervention villages periodically. A physician in the clinic will confirm the diagnosis, provide guideline-based treatment and follow up patients. The CHWs will make home visits once a month to ensure medication compliance and counsel patients to reduce salt consumption and quit tobacco and alcohol. In the EUC arm, households will be provided information on the ill effects of tobacco use and steps to quit it. Individuals from both the arms will have access to the government’s national programme for the prevention and control of non-communicable diseases, where treatment for hypertension, diabetes and preventive treatment after stroke is available at the nearest primary health centres (PHCs). The intervention will be implemented for 3.5 years. The primary outcome will be a reduction in stroke mortality in the last 2.5 years of the intervention. Discussion This trial will provide important information regarding the feasibility and effect of a community-based preventive intervention package on stroke mortality in a rural under-resourced setting and can inform India’s non-communicable diseases prevention and control programme. If successful, such an intervention can be scaled up in the rural regions of India and other countries. Trial registration Clinical Trials Registry of India: CTRI/2015/12/006424. Registered on 8 December 2015.

scholarly journals Effect of a community-based intervention for cardiovascular risk factor control on stroke mortality in rural Gadchiroli, India: study protocol for a cluster randomised controlled trial

2019 ◽  
Author(s):  
Yogeshwar Kalkonde ◽  
Mahesh Deshmukh ◽  
Sindhu Nila ◽  
Sunil Jadhao ◽  
Abhay Bang
Keyword(s):  
Randomised Controlled Trial ◽  
Prevention And Control ◽  
Preventive Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Stroke Mortality ◽  
Community Based ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
And Control

Abstract Background Stroke has emerged as a leading cause of death in rural India. However, well tested healthcare interventions to reduce stroke mortality in rural under-resourced settings are lacking. The aim of this study is to evaluate the effect of a community-based preventive intervention on stroke mortality in rural Gadchiroli, India. Methods The study is a two-arm, parallel group, cluster randomised controlled trial where 32 villages each will be randomised to the intervention and the enhanced usual care (EUC) arm. In the intervention arm, individuals ≥ 50 years of age will be screened for hypertension, diabetes and stroke by trained Community Health Workers (CHWs). Screen positive individuals will be referred to a mobile outreach clinic which will visit intervention villages. A physician in the clinic will confirm the diagnosis, provide guideline-based treatment and follow up patients at periodic intervals. The CHWs will make home visits once a month to ensure medication compliance and counsel patients to reduce salt consumption and quit tobacco and alcohol. In the EUC arm, households will be provided information on the ill effects of tobacco and steps to quit it. Individuals from both the arms will have access to government’s national programme for prevention and control of non-communicable diseases where treatment for hypertension, diabetes and preventive treatment after stroke is available, nearest at the primary health centres (PHCs). The intervention will be implemented for 3.5 years. The primary outcome will be reduction in stroke mortality in the last 2.5 years of the intervention. Discussion This trial will provide important information regarding the feasibility and effect of a community-based preventive intervention package on stroke mortality in a rural under-resourced setting and can inform India’s non-communicable diseases prevention and control programme. If successful, such an intervention can be scaled up in rural regions of India and other countries.

scholarly journals Sustainable waiting time reductions after introducing the STAT model for access and triage: 12-month follow up of a stepped wedge cluster randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Katherine E. Harding ◽  
David A. Snowdon ◽  
Luke Prendergast ◽  
Annie K. Lewis ◽  
Bridie Kent ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Waiting Time ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
Stepped Wedge ◽  
Community Based ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background Timely access is a challenge for providers of outpatient and community-based health services, as seen by the often lengthy waiting lists to manage demand. The Specific Timely Appointments for Triage (STAT) model, an alternative approach for managing access and triage, reduced waiting time by 34% in a stepped wedge cluster randomised controlled trial involving 8 services and more than 3000 participants. Follow up periods ranged from 3 to 10 months across the participating services in accordance with the stepped wedge design. This study aimed to determine whether outcomes were sustained for a full 12 months after implementation of the STAT model at each site. Methods Routinely collected service data were obtained for a total of 12 months following implementation of the STAT model at each of the 8 services that participated in a stepped wedge cluster randomised controlled trial. The primary outcome was time to first appointment. Secondary outcomes included non-attendance rates, time to second appointment and service use over 12 weeks. Outcomes were compared to pre-intervention data from the original trial, modelled using generalised linear mixed effects models accounting for clustering of sites. Results A 29% reduction in waiting time could be attributed to STAT over 12 months, compared to 34% in the original trial. A reduction in variability in waiting time was sustained. There were no significant changes in time to second appointment or in the number of missed appointments in the extended follow up period. Conclusions STAT is an effective strategy for reducing waiting time in community-based outpatient services. At 12 months, small reductions in the overall effect are apparent, but reductions in variability are sustained, suggesting that people who previously waited the longest benefit most from the STAT model. Trial registration This is a 12-month follow up of a stepped wedge cluster randomised controlled trial that was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12615001016527).

scholarly journals The EmpaTeach intervention for reducing physical violence from teachers to students in Nyarugusu Refugee Camp: A cluster-randomised controlled trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (10) ◽  
pp. e1003808
Author(s):  
Camilla Fabbri ◽  
Katherine Rodrigues ◽  
Baptiste Leurent ◽  
Elizabeth Allen ◽  
Mary Qiu ◽  
...  
Keyword(s):  
Violence Prevention ◽  
Primary Outcome ◽  
Physical Violence ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Refugee Camp ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
And Control

Background School-based violence prevention interventions offer enormous potential to reduce children’s experience of violence perpetrated by teachers, but few have been rigorously evaluated globally and, to the best of our knowledge, none in humanitarian settings. We tested whether the EmpaTeach intervention could reduce physical violence from teachers to students in Nyarugusu Refugee Camp, Tanzania. Methods and findings We conducted a 2-arm cluster-randomised controlled trial with parallel assignment. A complete sample of all 27 primary and secondary schools in Nyarugusu Refugee Camp were approached and agreed to participate in the study. Eligible students and teachers participated in cross-sectional baseline, midline, and endline surveys in November/December 2018, May/June 2019, and January/February 2020, respectively. Fourteen schools were randomly assigned to receive a violence prevention intervention targeted at teachers implemented in January–March 2019; 13 formed a wait-list control group. The EmpaTeach intervention used empathy-building exercises and group work to equip teachers with self-regulation, alternative discipline techniques, and classroom management strategies. Allocation was not concealed due to the nature of the intervention. The primary outcome was students’ self-reported experience of physical violence from teachers, assessed at midline using a modified version of the ISPCAN Child Abuse Screening Tool–Child Institutional. Secondary outcomes included student reports of emotional violence, depressive symptoms, and school attendance. Analyses were by intention to treat, using generalised estimating equations adjusted for stratification factors. No schools left the study. In total, 1,493 of the 1,866 (80%) randomly sampled students approached for participation took part in the baseline survey; at baseline 54.1% of students reported past-week physical violence from school staff. In total, 1,619 of 1,978 students (81.9%) took part in the midline survey, and 1,617 of 2,032 students (79.6%) participated at endline. Prevalence of past-week violence at midline was not statistically different in intervention (408 of 839 students, 48.6%) and control schools (412 of 777 students, 53.0%; risk ratio = 0.91, 95% CI 0.80 to 1.02, p = 0.106). No effect was detected on secondary outcomes. A camp-wide educational policy change during intervention implementation resulted in 14.7% of teachers in the intervention arm receiving a compressed version of the intervention, but exploratory analyses showed no difference in our primary outcome by school-level adherence to the intervention. Main study limitations included the small number of schools in the camp, which limited statistical power to detect small differences between intervention and control groups. We also did not assess the test–retest reliability of our outcome measures, and interviewers were unmasked to intervention allocation. Conclusions There was no evidence that the EmpaTeach intervention effectively reduced physical violence from teachers towards primary or secondary school students in Nyarugusu Refugee Camp. Further research is needed to develop and test interventions to prevent teacher violence in humanitarian settings. Trial registration clinicaltrials.gov (NCT03745573)

scholarly journals Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India

2021 ◽  
Vol 6 (6) ◽  
pp. e003902
Author(s):  
Rachana Parikh ◽  
Adriaan Hoogendoorn ◽  
Daniel Michelson ◽  
Jeroen Ruwaard ◽  
Rhea Sharma ◽  
...  
Keyword(s):  
Mental Health ◽  
Low Income ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
New Delhi ◽  
Stepped Wedge ◽  
Whole School ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionWe evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems.MethodsWe conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents.ResultsBetween 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001).ConclusionA single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India.Trial registration numberNCT03633916.

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