| CTRI Number |
CTRI/2020/01/022668 [Registered on: 09/01/2020] Trial Registered Prospectively |
| Last Modified On: |
19/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To test the putting into use status of Indian Hypertension (blood pressure)Management Initiative(IHMI)in Thiruvananthapuram district |
|
Scientific Title of Study
|
A study to assess the implementation status of "Indian Hypertension Management Initiative(IHMI)" in Thiruvananthapuram District |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Balamurali |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Health Policy,
Prasanna School of Public Health, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
8547332068 |
| Fax |
|
| Email |
balamurali94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumar Sumit |
| Designation |
Assistant Proffessor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Health Policy,
Prasanna School of Public Health, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
kumar.sumit@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumar Sumit |
| Designation |
Assistant Proffessor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Health Policy,
Prasanna School of Public Health, Manipal Academy of Higher Education
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
kumar.sumit@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Individual- Dr V Balamurali
Department of Health Policy,
Prasanna School of Public Health,Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 V Balamurali |
Health Centers of Thiruvananthapuram and kottayam district |
Directorate of health services,Thiruvananthapuram district,Kerala 695035
Thiruvananthapuram
KERALA |
8547332068
balamurali94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kastturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All Stakeholders of Indian Hypertension Management Initiative(IHMI) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The results of study will help in identifying gaps in implementation of the initiative |
April- mid |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The results of study will act as a source to take informed decisions about program in future |
August- mid |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/01/2020 |
| Date of Study Completion (India) |
18/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Non Communicable Diseases (NCDs) are a leading cause of death globally(71%) among which 31% is due to Cardio-Vascular Diseases (CVDs). Hypertension is a significant risk factor for CVDs. The prevalence of hypertension in Kerala is 34% out of which only 44% are aware of their status with a control rate of just 13%. Hypertension can be controlled if diagnosed on time. In this backdrop Indian Hypertension Management Initiative (IHMI) was launched in 2017 November to reduce CVDs by controlling hypertension. As IHMI is in its budding stage , the current study will provide an insight into the implementation status and existing gaps in the initiative. The findings of study can be taken up for informed intervention applicable to local settings. |