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SMARThealth India: A stepped-wedge, cluster randomised controlled trial of a community health worker managed mobile health intervention for people assessed at high cardiovascular disease risk in rural India.

ABSTRACT: 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.

SUBMITTER: Peiris D

PROVIDER: S-EPMC6435227 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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SMARThealth India: A stepped-wedge, cluster randomised controlled trial of a community health worker managed mobile health intervention for people assessed at high cardiovascular disease risk in rural India.

Peiris David D Praveen Devarsetty D Mogulluru Kishor K Ameer Mohammed Abdul MA Raghu Arvind A Li Qiang Q Heritier Stephane S MacMahon Stephen S Prabhakaran Dorairaj D Clifford Gari D GD Joshi Rohina R Maulik Pallab K PK Jan Stephen S Tarassenko Lionel L Patel Anushka A

PloS one 20190326 3

<h4>Background</h4>Cardiovascular diseases (CVD) are rising in India resulting in major health system challenges.<h4>Methods</h4>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 car ...[more]

PMID: 30913216

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Project description:OBJECTIVES:There is emerging interest and data supporting the effectiveness of community health workers (CHWs) in non-communicable diseases (NCDs) in low/middle-income countries (LMICs). This study aimed to determine whether a CHW-led intervention targeting diabetes and hypertension could improve markers of clinical disease control in rural Mexico. DESIGN AND SETTING:A prospective observational stepped-wedge study was conducted across seven communities in rural Chiapas, Mexico from March 2014 to April 2018. PARTICIPANTS:149 adults with hypertension and/or diabetes. INTERVENTION:This study was conducted in the context of the programmatic roll-out of an accompaniment-based CHW-led intervention designed to complement comprehensive primary care for adults with diabetes and/or hypertension. Implementation occurred sequentially at 3-month intervals with point-of-care data collected at baseline and every 3?months thereafter for 12 months following roll-out in all communities. OUTCOME MEASURES:Primary outcomes were glycated haemoglobin (HbA1c) and systolic blood pressure (SBP), overall and stratified by baseline disease control. We conducted an individual-level analysis using mixed effects regression, adjusting for time, cohort and clustering at the individual and community levels. RESULTS:Among patients with diabetes, the CHW-led intervention was associated with a decrease in HbA1c of 0.35%; however, CIs were wide (95%?CI -0.90% to 0.20%). In patients with hypertension, there was a 4.7?mm Hg decrease in SBP (95%?CI -8.9 to -0.6). In diabetic patients with HbA1c ?9%, HbA1c decreased by 0.96% (95% CI -1.69% to -0.23%), and in patients with uncontrolled hypertension, SBP decreased by 10.2?mm Hg (95%?CI -17.7 to -2.8). CONCLUSIONS:We found that a CHW-led intervention resulted in clinically meaningful improvement in disease markers for patients with diabetes and hypertension, most apparent among patients with hypertension and patients with uncontrolled disease at baseline. These findings suggest that CHWs can play a valuable role in supporting NCD management in LMICs. TRIAL REGISTRATION NUMBER:NCT02549495.

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: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.

Dataset Information

SMARThealth India: A stepped-wedge, cluster randomised controlled trial of a community health worker managed mobile health intervention for people assessed at high cardiovascular disease risk in rural India.

Publications

SMARThealth India: A stepped-wedge, cluster randomised controlled trial of a community health worker managed mobile health intervention for people assessed at high cardiovascular disease risk in rural India.

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