Dataset Information

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.

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.

SUBMITTER: Kalkonde Y

PROVIDER: S-EPMC6929484 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Publications

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.

Kalkonde Yogeshwar Y Deshmukh Mahesh M Nila Sindhu S Jadhao Sunil S Bang Abhay A

Trials 20191223 1

<h4>Background</h4>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.<h4>Methods</h4>The study is a two-arm, parallel group, cluster randomised controlled trial in which 32 villages will be randomised to the intervention and th ...[more]

PMID: 31870394

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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:BackgroundPopulation based estimates of the burden of pain in back and extremities (PBE) are lacking from rural India. We estimated this burden, measured as a) 12-month prevalence, b) site specific prevalence c) total number of painful sites per adult, d) severity of pain and e) duration of pain in the rural adult population in Gadchiroli, India, over a period of 12 months.MethodsThis population-based, cross-sectional study was conducted in two villages randomly selected from a cluster of 7 eligible villages in Gadchiroli district of India. All adults ≥20 years in these villages were surveyed by the trained community health workers in January 2010 by making household visits. The data were collected using a structured, pretested questionnaire on the history of pain in back and extremities (PBE) at various anatomical sites and its features during the previous 12 months.ResultsOut of 2535 eligible adults in two villages, 2259 (89%) were interviewed, of which 1876 (83%) had an episode of PBE in the preceding 12 months. The period prevalence of pain was 76% in back (including lower back, thoracic and neck) and 71% in the extremities. Highest site specific prevalence was at lower back (70%), knee (46%), neck (44%), leg/calf (39%) and mid-back (39%). The mean number of painful sites per adult was 4.57 (standard deviation (SD) = 4.17). The prevalence of severe pain was 15%. The mean number of painful days due to PBE was 166 days. Female gender (odds ratio (OR) = 2.8, 95% confidence interval (CI) = 2.1-3.6), farming/labour occupation (OR = 1.8, 95% CI = 1.4-2.4), increasing age (more than 60 years OR = 6.3, 95% CI = 3.3-11.9) were significantly associated with the risk of PBE.ConclusionNearly five out of six adults in rural Gadchiroli suffered from pain in back or extremities during the preceding 12 months. Pain was at multiple sites and was present on a mean 166 days in the year. Female gender, farming / manual labor as occupation and increasing age were the key risk factors identified. The pain in back and extremities emerges as a public health priority in rural communities.

Project description:BackgroundPopulation based estimates of the extent of the activity limitation due to back pain and disability due to musculoskeletal pains are lacking from rural India. We estimated this burden as a) extent of activity limitation due to back pain, b) disability due to musculoskeletal pains, c) grading of the limitation of each activity due to back and musculoskeletal pain in the rural adult population in Gadchiroli, India.MethodsThis population-based, cross-sectional study was conducted in two villages randomly selected from a cluster of 7 eligible villages in Gadchiroli district of India. All adults ≥20 years in these villages were surveyed by the trained community health workers in January 2010. Disability due to back pain was evaluated using newly developed questionnaire for women and men which assessed limitations in the gender-specific daily household and occupational activities in a rural area. Disability due to pain in extremities was assessed using the Health Assessment Questionnaire (HAQ).ResultsThe total population of the two villages was 3735 out of which 2535 (67.9%) were adults ≥20 years of age and were eligible to participate in the study. Of these, 2259 (89%) were interviewed and 1247 participants (55%) had any pain on the day of the survey. Activity limitation questionnaire was filled for 716 (91.4%) out of 783 patients with back pain. HAQ scale was filled for 524 (85.2%) out of 615 patients with pain in extremities. Among men with back pain, respectively 11%, 19%, 60% and 11% had no, mild, moderate to severe difficulty or were completely unable to perform agrarian work, while among women, respectively 6%, 20%, 69% and 4% had no, mild, moderate to severe difficulty or were completely unable to perform household activities. Based on the HAQ score, respectively 1%, 67%, 18% and 14% of the participants had no, mild, moderate to severe disability or were completely unable to perform the activities.ConclusionsThis community-based study in rural Gadchiroli demonstrates significant mild to moderate disability and activity limitation, due to pain in back and extremities in a population involved in hard manual work, especially agricultural and underlines the need to address the problem through appropriate interventions. The study also employs for the first time an indigenously developed questionnaire to identify activity limitation due to back pain, and demonstrates the method as well as the questionnaire.

Project description:BackgroundA variety of mobile-based health technologies (mHealth) have been developed for use by community health workers to augment their performance. One such mHealth intervention-ReMiND program, was implemented in a poor performing district of India. Despite some research on the extent of its effectiveness, there is significant dearth of evidence on cost-effectiveness of such mHealth interventions. In this paper we evaluated the incremental cost per disability adjusted life year (DALY) averted as a result of ReMiND intervention as compared to routine maternal and child health programs without ReMiND.MethodsA decision tree was parameterized on MS-Excel spreadsheet to estimate the change in DALYs and cost as a result of implementing ReMiND intervention compared with routine care, from both health system and societal perspective. A time horizon of 10 years starting from base year of 2011 was considered appropriate to cover all costs and effects comprehensively. All costs, including those during start-up and implementation phase, besides other costs on the health system or households were estimated. Consequences were measured as part of an impact assessment study which used a quasi-experimental design. Proximal outputs in terms of changes in service coverage were modelled to estimate maternal and infant illnesses and deaths averted, and DALYs averted in Uttar Pradesh state of India. Probabilistic sensitivity analysis was undertaken to account for parameter uncertainties.ResultsCumulatively, from year 2011 to 2020, implementation of ReMiND intervention in UP would result in a reduction of 312 maternal and 149,468 neonatal deaths. This implies that ReMiND program led to a reduction of 0.2% maternal and 5.3% neonatal deaths. Overall, ReMiND is a cost saving intervention from societal perspective. From health system perspective, ReMiND incurs an incremental cost of INR 12,993 (USD 205) per DALY averted and INR 371,577 (USD 5865) per death averted.ConclusionsOverall, findings of our study suggest strongly that the mHealth intervention as part of ReMiND program is cost saving from a societal perspective and should be considered for replication elsewhere in other states.

Project description:BackgroundUse of alteplase improves outcome in some patients with stroke. Several types of barrier frequently prevent its use. We assessed whether a standardised, barrier-assessment, multicomponent intervention could increase alteplase use in community hospitals in Michigan, USA.MethodsIn a cluster-randomised controlled trial, we selected adult, non-specialty, acute-care community hospitals in the Lower Peninsula of Michigan, USA. Eligible hospitals discharged at least 100 patients who had had a stroke per year, had less than 100 000 visits to the emergency department per year, and were not academic comprehensive stroke centres. Using a computer-generated randomisation sequence, we selected 12 matched pairs of eligible hospitals. Within pairs, the hospitals were allocated to intervention or control groups with restricted randomisation in January, 2007. Between January, 2007, and December, 2007, intervention hospitals implemented a multicomponent intervention that included qualitative and quantitative assessment of barriers to alteplase use and ways to address the findings, and provided additional support. The primary outcome was change in alteplase use in patients with stroke in emergency departments between the pre-intervention period (January, 2005, to December, 2006) and the post-intervention period (January, 2008, to January, 2010). Physicians in participating hospitals and the coordinating centre could not be masked to group assignment, but were masked to progress made in paired control hospitals. External medical reviewers who were masked to group assignment assessed outcomes. We did intention-to-treat (ITT) and target-population (without one pair that was excluded after randomisation) analyses. This trial is registered at ClinicalTrials.gov, number NCT00349479.FindingsAll 24 hospitals completed the study. Overall, 745 of 40 823 patients with stroke received intravenous alteplase treatment. In the ITT analysis, the proportion of patients with stroke who were admitted and treated with alteplase increased between the pre-intervention and post-intervention periods in intervention hospitals (89 [1·25%] of 7119 patients to 235 [2·79%] of 8419) to a greater extent than in control hospitals (99 [1·25%] of 7946 to 194 [2·10%] of 9222), but the difference between groups was not significant (relative risk [RR] 1·37, 95% CI 0·96-1·93; p=0·08). In the target-population analysis, the increase in alteplase use in intervention hospitals (59 [1·00%] of 5882 to 191 [2·62%] of 7288) was significantly greater than in control hospitals (65 [1·09%] of 5957 to 120 [1·72%] of 6989; RR 1·68, 95% CI 1·09-2·57; p=0·02), but was still clinically modest.InterpretationThe intervention did not significantly increase alteplase use in patients with ischaemic stroke. The increase in use of alteplase in the target population was significant, but smaller than the effect to which the study was powered. Additional strategies to increase acute stroke treatment are needed.FundingNational Institutes of Health National Institute of Neurological Disorders and Stroke.

Project description:BackgroundEffective and scalable behaviour change interventions to increase use of existing toilets in low income settings are under debate. We tested the effect of a novel intervention, the '5 Star Toilet' campaign, on toilet use among households owning a toilet in a rural setting in the Indian state of Gujarat.MethodsThe intervention included innovative and digitally enabled campaign components delivered over 2 days, promoting the upgrading of existing toilets to achieve use by all household members. The intervention was tested in a cluster randomised trial in 94 villages (47 intervention and 47 control). The primary outcome was the proportion of households with use of toilets by all household members, measured through self- or proxy-reported toilet use. We applied a separate questionnaire tool that masked open defecation questions as a physical activity study, and excluded households surveyed at baseline from the post-intervention survey. We calculated prevalence differences using linear regression with generalised estimating equations.ResultsThe primary study outcome was assessed in 2483 households (1275 intervention and 1208 control). Exposure to the intervention was low. Post-intervention, toilet use was 83.8% in the control and 90.0% in the intervention arm (unadjusted difference + 6.3%, 95%CI 1.1, 11.4, adjusted difference + 5.0%, 95%CI -0.1, 10.1. The physical activity questionnaire was done in 4736 individuals (2483 intervention and 2253 control), and found no evidence for an effect (toilet use 80.7% vs 82.2%, difference + 1.7%, 95%CI -3.2, 6.7). In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%). Process evaluation suggested that insufficient campaign intensity may have contributed to the low impact of the intervention.ConclusionThe study highlights the challenge in achieving high intervention intensity in settings where the proportion of the total population that are potential beneficiaries is small. Responder bias may be minimised by masking open defecation questions as a physical activity study. Over-reporting of toilet use may be further reduced by avoiding repeated surveys in the same households.Trial registrationThe trial was registered on the RIDIE registry ( RIDIE-STUDY-ID-5b8568ac80c30 , 27-8-2018) and retrospectively on clinicaltrials.gov ( NCT04526171 , 30-8-2020).

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).

Dataset Information

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.

Background

Methods

Discussion

Trial registration

Publications

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.

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