A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)

Healthy Clinical Trial

— STRI  

Official title:

A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04784208
• Other study ID #: EPIDI077
• Status: Recruiting
• Start date: January 18, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Abbott
• Contact: Dr Prasanna Kumar
• Phone: 919845156811
• Email: dr.kmpk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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

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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy
• Hypothyroidism

Intervention

Diagnostic Test:
• Blood test for Thyroid stimulating hormone (TSH)
Blood test for Thyroid stimulating hormone (TSH)

Locations

Country	Name	City	State
India	Center for Diabetes and Endocrine care	Bangalore
India	Apollo Excelcare Hospital	Guwahati
India	Care Outpatient Centre	Hyderabad
India	Dr. MV Rama Mohan, MD, DM	Hyderabad
India	FS Endocrine and Diabetic Centre	Hyderabad
India	Diabetes Thyroid Endocrine Center	Jaipur
India	Ananda Clinic	Kolkata
India	Healthy Lifestyle Clinic	Kolkata
India	Diabecare	Mumbai	Maharashtra
India	Khandelwal Diabetes Thyroid & Endocrinology Clinic	New Delhi
India	Chellaram Diabetes Institute	Pune

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To be able to develop a questionnaire (Q'SHY) for the identification and screening of subjects with suspected hypothyroidism	The aim is to develop a questionnaire considering literature review for symptoms selection, medical review of symptoms appropriateness, assigning weightage & questionnaire construction followed by expert review to construct a questionnaire	through out the study upto 1 year
Primary	To be able 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.	Through this study, we want to assess the validity of the questionnaire after receiving and comparing responses received from healthy volunteers and treatment naïve subjects with hypothyroidism through out the study we will have face validation of survey questionnaire - Face validation of survey questionnaire in hypothyroidism naïve and treatment naïve patients of hypothyroidism, revision of questionnaire if required after expert review of validation results	through out the study upto 1 year
Primary	To be able to establish a valid questionnaire with a robust sensitivity and specificity to detect signs and symptoms of hypothyroidism	in this, Pilot survey in hypothyroidism naïve and treatment naïve patients of hypothyroidism will be conducted and data will be analyzed and used to establish validation.	through out the study upto 1 year