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CTRI Number  CTRI/2015/12/006424 [Registered on: 08/12/2015] Trial Registered Prospectively
Last Modified On: 31/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   A community-based programme for reducing the burden of stroke in rural Gadchiroli, Maharashtra, India  
Scientific Title of Study   The effect of a community-based programme for cardiovascular risk factor control on stroke mortality in rural Gadchiroli, India: A cluster randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogeshwar V Kalkonde MD MSc 
Designation  Team Leader, Rural Chronic Non-communicable Diseases Research Programme and Consultant Neurologist 
Affiliation  Society for Education, Action and Research in Community Health 
Address  SEARCH, Shodhgram PO and District Gadchiroli

Gadchiroli
MAHARASHTRA
442605
India 
Phone  91-7138-255407  
Fax  91-7138-255411  
Email  yvkalkonde@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogeshwar V Kalkonde MD MSc 
Designation  Team Leader, Rural Chronic Non-communicable Diseases Research Programme and Consultant Neurologist 
Affiliation  Society for Education, Action and Research in Community Health 
Address  SEARCH, Shodhgram PO and District Gadchiroli

Gadchiroli
MAHARASHTRA
442605
India 
Phone  91-7138-255407  
Fax  91-7138-255411  
Email  yvkalkonde@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhay T Bang MD MPH 
Designation  Director, SEARCH 
Affiliation  Society for Education, Action and Research in Community Health 
Address  Shodhgram, PO and District Gadchiroli

Gadchiroli
MAHARASHTRA
442605
India 
Phone  91-7138-255407  
Fax  91-7138-255411  
Email  search.gad@gmail.com  
 
Source of Monetary or Material Support  
The Wellcome Trust/DBT India Alliance 
 
Primary Sponsor  
Name  Society for Education Action and Research in Community Health SEARCH 
Address  Shodhgram, PO and Dist Gadchiroli 
Type of Sponsor  Other [Non-Governmental Organisation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogeshwar Kalkonde MD MSc  Gadchiroli  SEARCH, Shodhgram
Gadchiroli
MAHARASHTRA 
91-7138-255407
91-7138-255411
yvkalkonde@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
SEARCH Institutional Ethical Committee  Approved 
SEARCH Institutional Ethical Committee  Approved 
SEARCH Institutional Ethical Committee  Approved 
SEARCH Institutional Ethical Committee  Approved 
SEARCH Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified, (2) ICD-10 Condition: I10||Essential (primary) hypertension, (3) ICD-10 Condition: E11||Type 2 diabetes mellitus, (4) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Community-based programme for cardiovascular risk factor control  The intervention will include- i) increasing awareness about stroke and its risk factors through yearly community-based awareness campaigns, ii) screening of all individuals 50 years of age and older in the intervention villages for hypertension and diabetes at the beginning of the intervention. This will be done by a community health worker using a electronic blood pressure monitor and checking for glycosuria using urine dipsticks, iii) simplified guideline-based treatment of patients with hypertension (using hydrochlorothiazide, amlodipine and atenolol), diabetes (using metformin and glipizide), and secondary prophylaxis of stroke (using low dose aspirin and a low-dose statin) by an outreach physician, and d) follow up of these patients for medication compliance by the community health worker and counseling of patients to reduce salt, tobacco and alcohol use. 
Comparator Agent  Enhanced usual care  Households in this arm will receive information pamphlets describing harmful effects of tobacco at the beginning and at the end of the intervention. The households in this area have access to care for chronic diseases provided by the government healthcare systems and private practitioners. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Cluster level:
Inclusion criteria: The village
1.should belong to the field practice area of SEARCH in Gadchiroli district
2.should have population >400

Individual level:
The individual should -
1.be a resident of the village
2.be 50 years of age or older
3.provide written, informed consent to receive the intervention

and with ANY of the conditions listed below to receive treatment and follow up under the intervention

4.with a mean systolic blood pressure of 140 mm Hg or above and mean diastolic blood pressure of 90 mm Hg or above (based on 2 separate readings taken 5 minutes apart) or with a diagnosis of hypertension and on antihypertensive medications,

5.with glycosuria detected using urine dipsticks during screening and random capillary blood glucose of 200 mg/dl or above; or those with outside records showing fasting plasma glucose 126 mg/dL or above or single random plasma blood glucose value of 200 mg/dL or above ; or previous diagnosis of diabetes and taking treatment for diabetes

6.with diagnosis of stroke defined using the World Health Organization’s definition as a focal (or at times global) neurological impairment of sudden onset, and lasting > 24 hours (or leading to death), and of presumed vascular origin.
 
 
ExclusionCriteria 
Details  Cluster level:
1.villages within 5 km distance from Gadchiroli town (district place)

Individual level:
1.terminally ill patients
2.patients with cardiovascular or kidney disease that can not be managed in primary care setting
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in stroke mortality   last 2.5 years of the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in all-cause mortality  last 2.5 years of the intervention 
Reduction in cardiovascular mortality  last 2.5 years of the intervention 
Number of individuals with hypertension taking antihypertensive medications   at baseline and at the end of 3.5 years of the intervention 
Blood pressure reduction in the intervention arm   at baseline and at the end of 3.5 years of the intervention 
Number of diabetic patients who have random capillary blood glucose of 200mg/dl or less in the intervention arm   at baseline and at the end of 3.5 years of the intervention 
Awareness about stroke and its risk factors (Which body organ is affected in stroke? Which diseases or factors increase the risk of stroke?)   at baseline and at the end of 3.5 years of the intervention 
 
Target Sample Size   Total Sample Size="5600"
Sample Size from India="5600" 
Final Enrollment numbers achieved (Total)= "15926"
Final Enrollment numbers achieved (India)="15926" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/01/2016 
Date of Study Completion (India) 31/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Kalkonde Y, Deshmukh M, Nila S, Jadhao S, Bang A. 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 Dec 23;20(1):764. doi: 10.1186/s13063-019-3870-x. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

With epidemiological transition, stroke is emerging as an important cause of death and disability in rural India and perpetuates poverty. Community-based interventions that controlled cardiovascular risk factors using well-established medications and lifestyle changes have reduced stroke mortality in developed countries. However, well tested community-based interventions to reduce the stroke mortality in rural areas of India as well as other developing countries are lacking. Stroke mortality in such areas can be potentially reduced in a cost effective manner by using simple guideline-based treatments of cardiovascular risk factors using generic medicines and increasing awareness about stroke. However, delivering such a care in rural areas where there is minimal awareness about stroke and its risk factors, economic resources are limited and healthcare for these problems in not easily available is logistically challenging.  

This study aims to address these challenges. In this cluster randomized, parallel group, two arm trial we will assess the effect of a healthcare delivery intervention package to control cardiovascular risk factors on stroke mortality. The study will be conducted in an underdeveloped rural area of central India. Thirty two villages will be randomly assigned to the intervention arm and will receive the healthcare delivery intervention while other 32 villages will be assigned to the control arm and will receive enhanced usual care in the form of health education on harmful effects of tobacco at the beginning and at the end of the intervention. The intervention will last for 3.5 years. The intervention will be jointly delivered by a village-based community health worker and a visiting outreach physician. It is a “3 plus 3” intervention in which the outreach physician will provide medical treatment for 3 conditions-hypertension, diabetes and secondary prophylaxis of stroke while the community health worker will provide lifestyle modification counseling to reduce 3 risk factors- salt, tobacco and alcohol use. In the intervention area all the individuals 50 years of age and above will be screened for hypertension, glycosuria and stroke by a village health worker at the beginning of the intervention. These patients will be evaluated by an outreach physician who will confirm the diagnoses and provide guideline-based medical treatment and follow up. The community health workers will follow these patients to promote medication compliance and provide lifestyle modification advice for reducing the risk factors discussed above.

 
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