| 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
|
|
|
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
|
|
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. |