| CTRI Number |
CTRI/2018/02/011892 [Registered on: 13/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to asses causes of death in rural villages |
|
Scientific Title of Study
|
A 12-MONTH PROSPECTIVE COMMUNITY BASED SURVEILLANCE OF ALL-AGE DEATHS USING VERBAL AUTOPSY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpa K |
| Designation |
DNB family medicine resident |
| Affiliation |
bangalore baptist hospital |
| Address |
Bangalore Baptist Hospital
Hebbal
Bangalore
Phone: 080-22024700
Bangalore
KARNATAKA
560024
India |
| Phone |
9986073633 |
| Fax |
|
| Email |
shilpagowda2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gift Norman |
| Designation |
HOD Community Health Department |
| Affiliation |
Bangalore Baptist hospital |
| Address |
Community Health Department
Bangalore Baptist Hospital
Bellary road hebbal Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
9591761106 |
| Fax |
|
| Email |
normangift@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gift Norman |
| Designation |
HOD Community Health Department |
| Affiliation |
Bangalore Baptist hospital |
| Address |
Community Health Department
Bangalore Baptist Hospital
Bellary road hebbal Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
9591761106 |
| Fax |
|
| Email |
normangift@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore baptist hospital
Bellary road Hebbal bangalore-560024 |
|
|
Primary Sponsor
|
| Name |
bangalore baptist hospital |
| Address |
Bangalore Baptist Hospital, Hebbal, Bangalore
Phone: 080-22024700
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrShilpaK |
Bangalore Baptist Hospital |
Dept of Family Medicine Bangalore Baptist Hospital, Hebbal, Bangalore
Bangalore
KARNATAKA |
9986073633
silpagowda2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review Board Bangalore Baptist Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All-age deaths occuring in 2014-2015 in 50 villages of Devanahalli taluk., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
all age deaths occuring in 30 villages of devanahalli taluk |
|
| ExclusionCriteria |
| Details |
migrants/ visitors whose death occur in devanahalli.
refusal to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cause of Death |
cross sectional data collected at single point of time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| crude death rate |
cross sectional data collected at single point of time. |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
Final Enrollment numbers achieved (Total)= "202"
Final Enrollment numbers achieved (India)="202" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2014 |
| Date of Study Completion (India) |
04/04/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
"none yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Understanding what the most prevalent causes of death are in a given population can help target preventive interventions and provide health servicesNEED AND JUSTIFICATION FOR THE STUDY: Routine registration systems are incomplete or inaccurate. Many of the completed death certificates failed to provide relevant information to allow adequate ICD-10 coding [4]. To identify preventable premature deaths. To identify the vulnerable group for increased risk of mortalityAIMS AND OBJECTIVES: A prospective surveillance study to ascertain the death rate and most probable cause of death and the determinants in Devanahalli taluk using verbal autopsy. Study design: Descriptive study. |