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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04784208
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott

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 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

Condition or disease Intervention/treatment
Hypothyroidism Healthy Diagnostic Test: Blood test for Thyroid stimulating hormone (TSH)

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Study Type : Observational
Estimated Enrollment : 232 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04784208


Contacts
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Contact: Dr Prasanna Kumar 919845156811 dr.kmpk@gmail.com

Locations
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India
Diabecare Recruiting
Mumbai, Maharashtra, India, 400706
Contact: Mahesh V Padsalge    91-9322509497    drmaheshpadsalge@gmail.com   
Principal Investigator: Mahesh Padsalge         
Center for Diabetes and Endocrine care Recruiting
Bangalore, India, 560043
Contact: Dr.Prasanna Kuamr         
Apollo Excelcare Hospital Recruiting
Guwahati, India, 781033
Contact: Manash P Baruah    91-8136018344    manashb2@gmail.com   
Principal Investigator: Manash P Baruah         
Care Outpatient Centre Recruiting
Hyderabad, India, 500034
Contact: Bipin Sethi    91-9440739238    endoinformationcare@gmail.com   
Principal Investigator: Bipin Sethi         
FS Endocrine and Diabetic Centre Recruiting
Hyderabad, India, 500059
Contact: Faraz Farishta    91-9885035977    drfarazfarishta@gmail.com   
Principal Investigator: Faraz Farishta         
Dr. MV Rama Mohan, MD, DM Recruiting
Hyderabad, India
Contact: Dr. MV Rama Mohan, MD, DM Kumar         
Diabetes Thyroid Endocrine Center Not yet recruiting
Jaipur, India, 302006
Contact: Surendra Sharma    91-9829010233    sksharmacr@gmail.com   
Principal Investigator: Surendra K Sharma         
Healthy Lifestyle Clinic Recruiting
Kolkata, India, 700014
Contact: Mary D'Cruz    91-9830152843    drmary91@gmail.com   
Principal Investigator: Mary D'Cruz         
Ananda Clinic Recruiting
Kolkata, India, 700034
Contact: Debmalya Sanyal    91-6289855117    drdebmalyasanyal@gmail.com   
Principal Investigator: Debmalya Sanyal         
Khandelwal Diabetes Thyroid & Endocrinology Clinic Recruiting
New Delhi, India, 110063
Contact: Deepak Khandelwal    '91-9968878561    khandelwalaiims@gmail.com   
Principal Investigator: Deepak Khandelwal         
Chellaram Diabetes Institute Recruiting
Pune, India, 411021
Contact: Unnikrishnan A Gopalkrishnan    91-9689287337    uagcdi@cdi.org.in   
Principal Investigator: Unnikrishnan Gopalkrishnan         
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Shivani Acharya Abbott
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT04784208    
Other Study ID Numbers: EPIDI077
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs