| CTRI Number |
CTRI/2019/02/017684 [Registered on: 14/02/2019] Trial Registered Prospectively |
| Last Modified On: |
13/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Descriptive Study |
| Study Design |
Other |
|
Public Title of Study
|
Improving Blood Pressure Control Among Older Adults in Chennai, India |
|
Scientific Title of Study
|
Improving Hypertension Management in Chennai |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Girija Suresh |
| Designation |
Deputy Medical Director and Head of the Department of General Medicine |
| Affiliation |
Sundaram Medical Foundation |
| Address |
Sundaram Medical Foundation Out Patient Services,
Door No.42 to 46, AD Block, IV Avenue, Shanthi Colony, Anna Nagar
Chennai
TAMIL NADU
600040
India |
| Phone |
9283127335 |
| Fax |
|
| Email |
girijasuresh59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girija Suresh |
| Designation |
Deputy Medical Director and Head of the Department of General Medicine |
| Affiliation |
Sundaram Medical Foundation |
| Address |
Sundaram Medical Foundation Out Patient Services,
Door No.42 to 46, AD Block, IV Avenue, Shanthi Colony, Anna Nagar
Chennai
TAMIL NADU
600040
India |
| Phone |
9283127335 |
| Fax |
|
| Email |
girijasuresh59@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikkil Sudharsanan |
| Designation |
Senior Research Fellow |
| Affiliation |
IFMR LEAD |
| Address |
IFMR LEAD, #4 2nd Floor, Buhari Towers, No. 4, Moores Road, Thousand Lights
Chennai
TAMIL NADU
600006
India |
| Phone |
9791182149 |
| Fax |
|
| Email |
nikkil.sudharsanan@uni-heidelberg.de |
|
|
Source of Monetary or Material Support
|
| Harvard University,
The Foundations of Human Behavior Initiative,
Littauer Center North, room M-13,
Harvard Economics Dept.,
1805 Cambridge St.,
Cambridge MA 02138, USA |
|
|
Primary Sponsor
|
| Name |
IFMR LEAD |
| Address |
#4 Second Floor, Buhari Towers, Moores Rd, Thousand Lights,
Chennai, Tamil Nadu 600006 |
| Type of Sponsor |
Research institution |
|
|
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 Girija Suresh |
Sundaram Medical Foundation Outpatient Clinic |
Door No.42 to 46, AD
Block, IV Avenue,
Shanthi Colony, Anna
Nagar, Chennai -
600040
Chennai
TAMIL NADU |
9283127335
girijasuresh59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMF Institutional Review Board/Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female, above the age 30 years
2. Have existing hypertension, newly diagnosed hypertension, or are
suspected of having hypertension.
3. Written informed consent must be obtained. |
|
| ExclusionCriteria |
| Details |
1. Individuals who have physical or cognitive limitations and
individuals with chronic kidney disease, heart disease, and prior
stroke. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
(a) Quality of care: Physician’s adherence to national guidelines
(b) Behavioral: Patient’s adherence to medical recommendations
(c) Behavioral: Missed hospital visits by patients
(d) Health: Blood pressure readings and anthropometric measurements (height, weight, and waist circumference) |
(a) At the point of data collection
(b) 4 months
(c) 4 months
(d) 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| (a) Self-reported reasons for missed medical recommendations |
(b) 4 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/03/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective cohort study of hypertensive, or suspected hypertensive, patients that aims to understand barriers to successful hypertension management. The study will be based in Chennai, India; approximately 1000 participants will be recruited from a private non-profit outpatient clinic. The study will begin by observing patients in the clinic then follow-up them up twice at their home, approximately two weeks and four months after their initial clinic visit. Dr. Nikkil Sudharsanan (nikkil.sudharsanan@uni-heidelberg.de), the contact person for public query and co-PI, will be responsible for the second study site i.e. community level interviews at the patients’ homes. The primary outcomes will be to measure the magnitude of physician adherence to hypertensive care guidelines at the point of the clinic visit and patient adherence to physician recommendations four months later. |