Dataset Information

A Stepped Wedge Cluster-Randomized Trial Assessing the Impact of a Riverbank Filtration Intervention to Improve Access to Safe Water on Health in Rural India.

ABSTRACT: Sustainable and low-cost methods for delivery of safe drinking water in resource-limited settings remain suboptimal, which contributes to global diarrhea morbidity. We aimed to assess whether delivery of riverbank filtration-treated water to newly installed water storage tanks (improved quality and access, intervention condition) reduced reported diarrhea in comparison to delivery of unfiltered river water (improved access alone, control condition) in rural Indian villages. We used a stepped wedge cluster-randomized trial (SW-CRT) design involving four clusters (villages). Selection criteria included village size, proximity to a river, and lack of existing or planned community-level safe water sources. All adults and children were eligible for enrollment. All villages started in the control condition and were sequentially randomized to receive the intervention at 3-month intervals. Our primary outcome was 7-day-period prevalence of self- or caregiver-reported diarrhea, measured at 3-month intervals (five time points). Analysis was by intention to treat. Because blinding was not possible, we incorporated questions about symptoms unrelated to water consumption to check response validity (negative control symptoms). We measured outcomes in 2,222 households (9,836 participants). We did not find a measurable reduction in diarrhea post-intervention (RR: 0.98 [95% CI: 0.24-4.09]); possible explanations include low intervention uptake, availability of other safe water sources, low baseline diarrheal prevalence, and reporting fatigue. Our study highlights both the difficulties in evaluating the impact of real-world interventions and the potential for an optimized SW-CRT design to address budgetary, funding, and logistical constraints inherent in such evaluations.

SUBMITTER: McGuinness SL

PROVIDER: S-EPMC7056407 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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A Stepped Wedge Cluster-Randomized Trial Assessing the Impact of a Riverbank Filtration Intervention to Improve Access to Safe Water on Health in Rural India.

McGuinness Sarah L SL O'Toole Joanne J Forbes Andrew B AB Boving Thomas B TB Patil Kavita K D'Souza Fraddry F Gaonkar Chetan A CA Giriyan Asha A Barker S Fiona SF Cheng Allen C AC Sinclair Martha M Leder Karin K

The American journal of tropical medicine and hygiene 20200301 3

Sustainable and low-cost methods for delivery of safe drinking water in resource-limited settings remain suboptimal, which contributes to global diarrhea morbidity. We aimed to assess whether delivery of riverbank filtration-treated water to newly installed water storage tanks (improved quality and access, intervention condition) reduced reported diarrhea in comparison to delivery of unfiltered river water (improved access alone, control condition) in rural Indian villages. We used a stepped wed ...[more]

PMID: 31264565

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Project description:BackgroundWhile effective lay-health worker models for mental health care have been demonstrated through efficacy trials, there is limited evidence of the effectiveness of these models implemented in rural LMIC settings.AimTo evaluate the impact of a volunteer community-led intervention on reduction in depression and anxiety symptoms and improvement in functioning, and social participation among people living in rural Gujarat, India.MethodsStepped-wedge cluster randomized controlled trial was used to assess the effectiveness of delivery of psychosocial intervention across 645 villages in Mehsana district of Gujarat, India between April 2017 and August 2019. The primary outcome was an improvement in depression and/or anxiety symptoms assessed using GHQ-12 at 3-month follow-up. Secondary outcomes were improvement in (a) depression and anxiety (Patient Health Questionnaire, (PHQ-9), Generalized Anxiety Disorder (GAD-7) & Self-Reporting Questionnaire-20 (SRQ-20); b) quality of life (EQ- 5D); c) functioning (WHO-DAS-12), and social participation (Social Participation Scale SPS). Generalized linear mixed-effects models were used to assess the independent effect of the intervention.ResultsOut of a total of 1191 trial participants (608- intervention & 583-control), 1014 (85%) completed 3-month follow-up. In an adjusted analysis, participants in the intervention condition showed significant recovery from symptoms of depression or anxiety (OR 2.2; 95% CI 1.2 to 4.6; p<0.05) at the end of 3-months, with effects sustained at 8-month follow-up (OR 3.0; 95% CI 1.6 to 5.9). Intervention participants had improved scores on the PHQ-9 (Adjusted mean difference (AMD) -1.8; 95%CI -3.0 to -0.6), and SRQ-20 (AMD -1.7; 95%CI -2.7 to -0.6), at 3-months and PHQ-9, GAD-7, SRQ-20, EQ-5D and WHO-DAS at 8 months follow-up.ConclusionFindings suggest that Atmiyata had a significant effect on recovery from symptoms of depression and anxiety with sustained effects at 8-month follow-up.Trial registrationTrial registration details. The trial was registered prospectively with the "Clinical Trial Registry in India" (registry number: CTRI/2017/03/008139).

Project description:BackgroundWhile lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide a package of community-based interventions for mental health, including evidence-based counseling for persons with common mental disorders (CMD).MethodsThe impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial is implemented across 10 sub-blocks (645 villages) in Mehsana district in the state of Gujarat, with a catchment area of 1.52 million rural adults. There are 56 primary health centers (PHCs) in Mehsana district and villages covered under these PHCs are equally divided into four groups of clusters of 14 PHCs each. The intervention is rolled out in a staggered manner in these groups of villages at an interval of 5?months. The primary outcome is symptomatic improvement measured through the GHQ-12 at a 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-Reporting Questionnaire-20 (SRQ-20), functioning using the World Health Organization's Disability Assessment Scale (WHO-DAS-12), depression symptoms using the Patient Health Questionnaire (PHQ-9), anxiety symptoms using Generalized Anxiety Disorder Questionnaire (GAD-7), and social participation using the Social Participation Scale (SPS). Generalized linear mixed effects model is employed for binary outcomes and linear mixed effects model for continuous outcomes. A Return on Investment (ROI) analysis of the intervention will be conducted to understand whether the intervention generates any return on financial investments made into the project.DiscussionStepped wedge designs are increasingly used a design to evaluate the real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a low- and middle-income country evaluating the impact of the implementation of a community mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in low- and middle-income countries.Trial registrationThe trial is registered prospectively with the Clinical Trial Registry in India and the Clinical Trial Registry number- CTRI/2017/03/008139. URL http://ctri.nic.in/Clinicaltrials/regtrial.php?modid=1&compid=19&EncHid=70845.17209. Date of registration- 20/03/2017.

Project description:BACKGROUND:Cardiovascular diseases (CVD) are rising in India resulting in major health system challenges. METHODS:Eighteen primary health centre (PHC) clusters in rural Andhra Pradesh were randomised over three, 6-month steps to an intervention comprising: (1) household CVD risk assessments by village-based community health workers (CHWs) using a mobile tablet device; (2) electronic referral and clinical decision support for PHC doctors; and (3) a tracking system for follow-up care. Independent data collectors screened people aged ≥ 40 years in 54 villages serviced by the PHCs to create a high CVD risk cohort (based on WHO risk charts and blood pressure thresholds). Randomly selected, independent samples, comprising 15% of this cohort, were reviewed at each 6-month step. The primary outcome was the proportion meeting systolic blood pressure (SBP) targets (<140mmHg). FINDINGS:Eight-four percent of the eligible population (n = 62,254) were assessed at baseline (18.4% at high CVD risk). Of those at high risk, 75.3% were followed up over two years. CHWs screened 85.9% of the baseline cohort and doctors followed up 70.0% of all high risk referrals. There was no difference in the proportion of people achieving SBP targets (41.2% vs 39.2%; adjusted odds ratio (OR) 1.01 95% CI 0.76-1.35) or receiving BP-lowering medications in the intervention vs control periods respectively. There was a high discordance in risk scores generated by independent data collectors and CHWs, resulting in only 37.2% of the evaluation cohort exposed to the intervention. This discordance was mainly driven by fluctuating BP values (both normal variability and marked seasonal variations). In the pre-specified high risk concordant subgroup, there was greater use of BP-lowering medications in the intervention period (54.3% vs 47.9%, OR 1.22, 95% CI 1.03-1.44) but no impact on BP control. CONCLUSIONS:The strategy was well implemented with increased treatment rates among high risk individuals assessed by CHWs, however effects on BP were not demonstrated. Use of guideline-recommended BP thresholds for identifying high risk individuals substantially affected the reproducibility of risk assessment, and thus the ability to reliably evaluate the effectiveness of the intervention. In addition, unanticipated seasonal variation in BP in the context of a stepped-wedge trial highlights the inherent risks of this study design. TRIAL REGISTRATION:Clinical Trials Registry of India CTRI/2013/06/ 003753.

Project description:BACKGROUND:Cluster randomised trials with unequal sized clusters often have lower precision than with clusters of equal size. To allow for this, sample sizes are inflated by a modified version of the design effect for clustering. These inflation factors are valid under the assumption that randomisation is stratified by cluster size. We investigate the impact of unequal cluster size when that constraint is relaxed, with particular focus on the stepped-wedge cluster randomised trial, where this is more difficult to achieve. METHODS:Assuming a multi-level mixed effect model with exchangeable correlation structure for a cross-sectional design, we use simulation methods to compare the precision for a trial with clusters of unequal size to a trial with clusters of equal size (relative efficiency). For a range of scenarios we illustrate the impact of various design features (the cluster-mean correlation - a function of the intracluster correlation and the cluster size, the number of clusters, number of randomisation sequences) on the average and distribution of the relative efficiency. RESULTS:Simulations confirm that the average reduction in precision, due to varying cluster sizes, is smaller in a stepped-wedge trial compared to the parallel trial. However, the variance of the distribution of the relative efficiency is large; and is larger under the stepped-wedge design compared to the parallel design. This can result in large variations in actual power, depending on the allocation of clusters to sequences. Designs with larger variations in cluster sizes, smaller number of clusters and studies with smaller cluster-mean correlations (smaller cluster sizes or smaller intra-cluster correlation) are particularly at risk. CONCLUSION:The actual realised power in a stepped-wedge trial might be substantially higher or lower than that estimated. This is particularly important when there are a small number of clusters or the variability in cluster sizes is large. Constraining the randomisation on cluster size, where feasible, might mitigate this effect.

Project description:BackgroundSchizophrenia is a persistent and debilitating mental illness, and its prognosis depends largely on supportive care and systematic treatment. In developing countries like China, families constitute the major caregiving force for schizophrenia and are faced with many challenges, such as lack of knowledge, skills, and resources. The approach to support family caregiving in an accessible, affordable, feasible, and cost-effective way remains unclear. The wide-spread use of WeChat provides a promising and cost-effective medium for support.ObjectiveWe aim to present a protocol for assessing a WeChat-based integrative family intervention (WIFI) to support family caregiving for schizophrenia.MethodsWe will develop a WIFI program that includes the following three core components: (1) psychoeducation (WeChat official account), (2) peer support (WeChat chat group), and (3) professional support (WeChat video chat). A rigorous stepped-wedge cluster randomized trial will be used to evaluate the implementation, effectiveness, and cost of the WIFI program. The WIFI program will be implemented in 12 communities affiliated with Changsha Psychiatric Hospital through the free medicine delivery process in the 686 Program. The 12 communities will be randomized to one of four fixed sequences every 2 months during an 8-month intervention period in four clusters of three communities each. Outcomes will be assessed for both family caregivers and people with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support, coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. People with schizophrenia will be assessed for their symptoms, functioning, quality of life, recovery, and rehospitalization. Cost data, such as intervention costs, health care utilization costs, and costs associated with lost productivity, will be collected. Moreover, we will collect process data, including fidelity and quality of program implementation, as well as user attitude data. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling with clusters as a random effect and time as a fixed effect. Cost-effectiveness analysis will be performed from the societal perspective using incremental cost-effectiveness ratios. Qualitative analysis will use the grounded theory approach and immersion-crystallization process.ResultsThe study was funded in August 2018 and approved by the institutional review board on January 15, 2019. Preliminary baseline data collection was conducted in May 2019 and completed in September 2019. The WIFI program is expected to start in September 2020.ConclusionsThis is the first study to assess a WeChat-based mHealth intervention to support family caregiving for schizophrenia in China. The innovative study will contribute to the development of a more cost-effective and evidence-based family management model in the community for people with schizophrenia, and the approach could potentially be integrated into national policy and adapted for use in other populations.Trial registrationClinicalTrials.gov NCT04393896; https://clinicaltrials.gov/ct2/show/NCT04393896.International registered report identifier (irrid)PRR1-10.2196/18538.

Dataset Information

A Stepped Wedge Cluster-Randomized Trial Assessing the Impact of a Riverbank Filtration Intervention to Improve Access to Safe Water on Health in Rural India.

Publications

A Stepped Wedge Cluster-Randomized Trial Assessing the Impact of a Riverbank Filtration Intervention to Improve Access to Safe Water on Health in Rural India.

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