| CTRI Number |
CTRI/2016/11/007487 [Registered on: 24/11/2016] Trial Registered Retrospectively |
| Last Modified On: |
24/11/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A survey for patients of hypothyroidism to understand their knowledge, attitude and practice. |
|
Scientific Title of Study
|
A questionnaire based survey on knowledge, attitude and practices of patients with hypothyroidism in India |
| Trial Acronym |
Thyroid KAP Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EPIDI049 Version 1.0 date 02 May 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bipin Sethi |
| Designation |
Consultant Endocrinologist |
| Affiliation |
Care Hospital |
| Address |
Care Hospital,H. No. 8-2-620/A/E,Road no.10, Banjara Hills,Hyderabad-500034
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
9848021482 |
| Fax |
|
| Email |
sethibipin54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Desai |
| Designation |
Associate Directore Clinical Operations And Pharmacovigilance |
| Affiliation |
Abbott India Limited |
| Address |
271, Business Park, 6th Flr
Model Industrial Colony
Off Aarey Road
Goregaon (E)
Mumbai 400 063
India
Mumbai
MAHARASHTRA
400 063
India |
| Phone |
|
| Fax |
|
| Email |
shubhangi.desai@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Desai |
| Designation |
Associate Directore Clinical Operations And Pharmacovigilance |
| Affiliation |
Abbott India Limited |
| Address |
271, Business Park, 6th Flr
Model Industrial Colony
Off Aarey Road
Goregaon (E)
Mumbai 400 063
India
MAHARASHTRA
400 063
India |
| Phone |
|
| Fax |
|
| Email |
shubhangi.desai@abbott.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abbott India Linited |
| Address |
Unit 3 4, Corporate business park Sion trombay road Chembur mumbai 400071 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S M Suresh |
Diacare and Research Centre |
Diacare and Research Centre, No. 723/B, 2nd Block, Rajajinagar,
Bangalore-560010
Bangalore
KARNATAKA |
9844011862
sureshhospital@gmail.com |
| Dr Jagdish Gotur |
Bhagat Polyclinic |
Dr Bhagats Polyclinic , Ganjanwala Lane, Ganjanwala Building II, Second Floor, Borivli (west), Mumbai - 92
Mumbai
MAHARASHTRA |
9892017519
drgotur@gmail.com |
| Dr Bipin Sethi |
Care Hospital |
"Care Hospital, H.No. 8-2-620/A/E, Road No.10, Banjara Hills. Landmark: Beside Rainbow Hospital & Opposite Karvy Building & Near Babu Khan Chamber,
Hyderabad-500034"
Hyderabad
ANDHRA PRADESH |
9848021482
sethibipin54@gmail.com |
| Dr Sailesh Lodha |
Dear Foundation |
Dear Foundation, 759, Mahaveer Nagar 1, Tonk Road, Jaipur-302018
Jaipur
RAJASTHAN |
9829019055
saileshlodha@rediffmail.com |
| Dr Mahesh V Padsalge |
Diabecare-Speciality Diabetes Centre |
"Diabecare-Speciality Diabetes Centre,
F2, D1, Devdarsan Apartment,
Sector 11, Nerul,
Navi Mumbai-400706"
Mumbai
MAHARASHTRA |
9322509497
drmaheshpadsalge@gmail.com |
| Dr Kirti Samudra |
Diabetes and Eye care Clinic |
Diabetes Care Clinic, Plot no - 15, V.M. Marg, Opposite Shreeyash Hospital, Sector -19, New Panvel-410206, Mumbai
Mumbai
MAHARASHTRA |
9867579565
dibocare@hotmail.com |
| Dr P Ramachandra |
DiaThy Clinic& Hormone Research Institute |
DiaThy Clinic& Hormone Research Institute, MIG2125, 12th Main, 16 cross, Near Dairy Cercle, Yalankar New Town, Bangalore-560064
Bangalore
KARNATAKA |
7795323949
praveenendocrine@gmail.com |
| Dr M S Raghavendra |
DOT Speciality Clinic |
Clinic,757/6, Garden School Road, Manjunath Nagar, Chikkalsandra
Bangalore-560008
Bangalore
KARNATAKA |
9448117141
dotsraghu@gmail.com |
| Dr M K Mukhopadhyay |
Dr Mukhopadhyay Clinic |
46 A, Richi Road . Kolkata 700019
Kolkata
WEST BENGAL |
9830203242
mkmukhopadhyay@yahoo.co.in |
| Dr Deepak Khandelwal |
Dr. Khandelwals Endocrinology Clinic |
Endocrinology Clinic GH1/1, Archana Apartment, opp Lal Market, Paschim Vihar, Delhi- 110087
West
DELHI |
9968878561
khandelwalaiims@gmail.com |
| Dr Amalselvam |
Joseph Medical Centre |
Joseph Medical Centre, lakshmipuram,
Bangalore-08
Bangalore
KARNATAKA |
9341252670
dramalselvam@gmail.com |
| Dr B K Malpani |
Malpani Nursing Home |
Near Langar ke Balaji,Gangori Bazar, Jaipur- 302001
Jaipur
RAJASTHAN |
9829054938
drbmalpani@gmail.com |
| Dr Ramesh Gupta |
Marudhar Hospital |
"Marudhar Hospital, A-93-99, Singh Bhoomi, Khatipura
Jaipur-302012"
Jaipur
RAJASTHAN |
9829016373
dockrgupta128@gmail.com |
| Dr Sanjay Gupta |
SG Diabetes Centre |
S G Diabetes Clinic, 123-D, Kamla Nagar, Delhi-110007
North
DELHI |
9873032981
drsanjaygupta12@gmail.com |
| Dr Ashish Saini |
Sparsh Speciality Clinic |
"Sparsh Speciality Clinic
B-5,Jangpura Extension, New Delhi – 110014
India"
New Delhi
DELHI |
9350113334
drashishsaini@yahoo.co.in |
| Dr Swati Srivastava |
Thyroid Clinic |
Thyroid Clinic, A-1/76, Chitrakoot, Jaipur- 302021
Jaipur
RAJASTHAN |
9828668733
swt_srivastava@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Conscience Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Hypothyrodism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender, aged ≥ 18 years taking treatment for hypothyroidism
2. Literate patients or patients able to read and write
3. Patients willing to sign the patient authorization form to participate in the KAP survey
|
|
| ExclusionCriteria |
| Details |
1. Patients newly diagnosed with hypothyroidism
2. Patients unwilling or unable to provide complete information as per the questionnaire
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the knowledge, attitude and practices of Indian patients with Hypothyroidism |
survey questionnaire. One time visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Obtaining Cronbanch alpha value for the questionnaire in the survey population |
survey questionnaire. One time visit |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a questionnaire based survey study. The study intends to assess the knowledge, attitude and practices of Indian patients by dispensing a questionnaire. The plan recruitment is for 500 patients all across India from 15-20 centers |