A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)
NCT ID: NCT04784208
Last Updated: 2022-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
232 participants
OBSERVATIONAL
2021-01-18
2022-12-31
Brief Summary
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Information about the Q'SHY:
* The Q'SHY- Questionnaire for Screening of Hypothyroidism is a Patient Reported Outcome (PRO) tool to enable screening for Hypothyroidism in the general population.
* It is a 20-item questionnaire which covers aspects of the symptoms of Hypothyroidism and incorporates the contributory factors from patient history which when combined, provides a robust tool to effectively screen the population.
* The questionnaire content is being created based on a thorough search for relevant literature and encompasses all important aspects for screening purposes
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Detailed Description
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1. To develop a questionnaire (Q'SHY) for the identification and screening of subjects with suspected hypothyroidism.
2. To assess the validity of the designed questionnaire by comparing the outcomes of the responses between General population subjects and treatment naïve subjects group with hypothyroidism.
3. The study aims to establish a valid questionnaire with a robust sensitivity and specificity to detect signs and symptoms of hypothyroidism.
Inclusion criteria for Subjects The criteria based on which, subjects in each Arm will be chosen to take part in the survey. Arm1: 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 Thyroid Stimulating Hormone \> 4.5 Milli international units per litre(mIU/L) within 2 weeks from the date of the 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 criteria for subjects 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.
1. Subjects are divided into 2 arms, with 100 subjects in each arm.
2. Phase -1
* Arm 1: Sixteen subjects from the general population who are naïve to their hypothyroid status with equal distribution of males and females.
* Arm 2: Sixteen subjects who are newly diagnosed patients of Hypothyroidism are treatment naïve with equal distribution of males and females
3. Phase -2
* Arm 1: One hundred subjects from the general population who are naïve to their hypothyroid status with equal distribution of males and females
* Arm 2: One hundred subjects who are newly diagnosed patients of Hypothyroidism are treatment naïve with equal distribution of males and females
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Arm 1-Healthy Volunteers
Arm 1: Subjects from the general population who are naïve to their hypothyroid status.
The Subjects will be randomly selected and will be equally stratified between genders and socio-economics statuses from places where groups of general populations are located
Blood test for Thyroid stimulating hormone (TSH)
Blood test for Thyroid stimulating hormone (TSH)
Arm 2- Hypothyroid treatment naïve patients
The subjects will be identified and selected from clinical settings such as hospitals, clinics and certified laboratories.
No interventions assigned to this group
Interventions
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Blood test for Thyroid stimulating hormone (TSH)
Blood test for Thyroid stimulating hormone (TSH)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Shivani Acharya
Role: STUDY_DIRECTOR
Abbott
Locations
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Diabecare
Mumbai, Maharashtra, India
Center for Diabetes and Endocrine care
Bangalore, , India
Apollo Excelcare Hospital
Guwahati, , India
Care Outpatient Centre
Hyderabad, , India
FS Endocrine and Diabetic Centre
Hyderabad, , India
Dr. MV Rama Mohan, MD, DM
Hyderabad, , India
Diabetes Thyroid Endocrine Center
Jaipur, , India
Healthy Lifestyle Clinic
Kolkata, , India
Ananda Clinic
Kolkata, , India
Khandelwal Diabetes Thyroid & Endocrinology Clinic
New Delhi, , India
Chellaram Diabetes Institute
Pune, , India
Countries
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Central Contacts
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Facility Contacts
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Dr.Prasanna Kuamr
Role: primary
Dr. MV Rama Mohan, MD, DM Kumar
Role: primary
Other Identifiers
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EPIDI077
Identifier Type: -
Identifier Source: org_study_id
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