| CTRI Number |
CTRI/2021/06/034139 [Registered on: 10/06/2021] Trial Registered Prospectively |
| Last Modified On: |
01/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess risk factors, medical adherence and consequences of non-communicable diseases |
|
Scientific Title of Study
|
TRACK NCDS-Tracking Risk factors, Adherence and Consequences of Non-Communicable Diseases – A population based Mixed methods approach |
| Trial Acronym |
TRACK NCDs |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anushka Priya Sharan |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
3rd FLoor, Department Of Community Medicine
Kasturba Medical College, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8670265518 |
| Fax |
|
| Email |
anushka.sharan@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chythra R Rao |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
3rd Floor, Department of Community Medicine
Kasturba Medical College, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448857793 |
| Fax |
|
| Email |
chythra.raj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chythra R Rao |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
3rd Floor, Department of Community Medicine
Kasturba Medical College, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448857793 |
| Fax |
|
| Email |
chythra.raj@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Tiger circle road, Madhav Nagar
Manipal
Udupi
Karnataka
576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Anushka Priya Sharan |
Kasturba Medical College, Manipal |
3rd Floor,Department Of Community Medicine
Kasturba Medical College, Madhav Nagar
Manipal
576104
Udupi
KARNATAKA |
8670265518
anushka.sharan@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes, Hypertension,Stroke,Hypothyroidism, CVD |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults >18 years of age of either gender
Permanent residents (residing for more than one year) |
|
| ExclusionCriteria |
| Details |
Severely ill patients
Unable to respond to the interview schedule |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prevalence of the risk factors of non-communicable diseases like tobacco usage, alcohol consumption, physical inactivity and unhealthy diet and the prevalence of the hypertension, diabetes, obesity and hypothyroidism |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The prevalence of stroke and heart diseases |
2 years |
|
|
Target Sample Size
|
Total Sample Size="1998"
Sample Size from India="1998"
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)
|
01/07/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be done to establish a community based non-communicable diseases cohort by evaluating the baseline prevalence of disease, risk factors & determinants. The study will also evaluate the facilitators and barriers of medical advice and treatment adherence in diabetics and hypertensives and systematically review the effective mHealth interventions aimed at improving adherence to therapy among patients with diabetes & hypertension. |