Status:
UNKNOWN
A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)
Lead Sponsor:
Abbott
Conditions:
Hypothyroidism
Healthy
Eligibility:
All Genders
18-65 years
Brief Summary
Type of Study Questionnaire- Development and validation Information about the Q'SHY: * The Q'SHY- Questionnaire for Screening of Hypothyroidism is a Patient Reported Outcome (PRO) tool to enable scr...
Detailed Description
Objectives The objectives of the study are as described in the below points. 1. To develop a questionnaire (Q'SHY) for the identification and screening of subjects with suspected hypothyroidism. 2. T...
Eligibility Criteria
Inclusion
- The criteria based on which, subjects in each Arm will be chosen to take part in the survey. Arm 1: Subjects from the general population who are naïve to their hypothyroid status.
- Male and female subjects between the age of 18 years and 65 years
- Willing to sign the Subject Authorization Form (SAF) Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve\*.
- Male and female subjects between the ages 18 years and 65 years.
- Subjects who had symptoms of hypothyroidism, were seen by a physician and diagnosed with hypothyroidism after laboratory testing of TSH \> 4.5 mIU/L within 2 weeks from the date of survey
- Willing to sign the SAF
- Willing to provide their Thyroid Function Test report that was used to diagnose Hypothyroidism. \* Treatment naive diagnosed on basis lab and clinical diagnosis within last 2 weeks
Exclusion
- Arm 1: Subjects from the general population who are naïve to their hypothyroid status
- Individuals less than 18 years of age and more than 65 years of age.
- Pregnant or lactating females
- Subjects previously diagnosed with and received treatment for thyroid diseases.
- Subjects not willing to sign the SAF. Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve
- Individuals less than 18 years of age and more than 65 years of age.
- Pregnant or lactating females
- Subjects previously diagnosed with and received treatment for thyroid diseases.
- Patients on treatment for Thyroid diseases Subjects not willing to sign the SAF.
- The above-mentioned criteria will be applicable to both Face validation and Pilot survey.
Key Trial Info
Start Date :
January 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT04784208
Start Date
January 18 2021
End Date
December 31 2022
Last Update
July 13 2022
Active Locations (11)
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1
Diabecare
Mumbai, Maharashtra, India, 400706
2
Center for Diabetes and Endocrine care
Bangalore, India, 560043
3
Apollo Excelcare Hospital
Guwahati, India, 781033
4
Care Outpatient Centre
Hyderabad, India, 500034