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

July 12, 2022 updated by: Abbott

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. 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

Study Type

Observational

Enrollment (Anticipated)

232

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • Bangalore, India, 560043
        • Recruiting
        • Center for Diabetes and Endocrine Care
        • Contact:
          • Dr.Prasanna Kuamr
      • Guwahati, India, 781033
        • Recruiting
        • Apollo Excelcare Hospital
        • Contact:
        • Principal Investigator:
          • Manash P Baruah
      • Hyderabad, India, 500034
        • Recruiting
        • Care Outpatient Centre
        • Contact:
        • Principal Investigator:
          • Bipin Sethi
      • Hyderabad, India, 500059
        • Recruiting
        • FS Endocrine and Diabetic Centre
        • Contact:
        • Principal Investigator:
          • Faraz Farishta
      • Hyderabad, India
        • Recruiting
        • Dr. MV Rama Mohan, MD, DM
        • Contact:
          • Dr. MV Rama Mohan, MD, DM Kumar
      • Jaipur, India, 302006
        • Not yet recruiting
        • Diabetes Thyroid Endocrine Center
        • Contact:
        • Principal Investigator:
          • Surendra K Sharma
      • Kolkata, India, 700014
        • Recruiting
        • Healthy Lifestyle Clinic
        • Contact:
        • Principal Investigator:
          • Mary D'Cruz
      • Kolkata, India, 700034
        • Recruiting
        • Ananda clinic
        • Contact:
        • Principal Investigator:
          • Debmalya Sanyal
      • New Delhi, India, 110063
        • Recruiting
        • Khandelwal Diabetes Thyroid & Endocrinology Clinic
        • Contact:
        • Principal Investigator:
          • Deepak Khandelwal
      • Pune, India, 411021
        • Recruiting
        • Chellaram Diabetes Institute
        • Contact:
        • Principal Investigator:
          • Unnikrishnan Gopalkrishnan
    • Maharashtra
      • Mumbai, Maharashtra, India, 400706
        • Recruiting
        • Diabecare
        • Contact:
        • Principal Investigator:
          • Mahesh Padsalge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To be able to develop a questionnaire (Q'SHY) for the identification and screening of subjects with suspected hypothyroidism
Time Frame: through out the study upto 1 year
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
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.
Time Frame: through out the study upto 1 year
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
To be able to establish a valid questionnaire with a robust sensitivity and specificity to detect signs and symptoms of hypothyroidism
Time Frame: through out the study upto 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Shivani Acharya, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIDI077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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