Clinical trial NCT04784208: A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)
Official title: A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypothyroidism
Healthy
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

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

Eligibility 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.

Primary outcomes:
measure: To be able to develop a questionnaire (Q'SHY) for the identification and screening of subjects with suspected hypothyroidism
timeFrame: through out the study upto 1 year
measure: 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.
timeFrame: through out the study upto 1 year
measure: To be able to establish a valid questionnaire with a robust sensitivity and specificity to detect signs and symptoms of hypothyroidism
timeFrame: through out the study upto 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Diabecare
state: Maharashtra
city: Bangalore
country: India
facility: Center for Diabetes and Endocrine care
city: Guwahati
country: India
facility: Apollo Excelcare Hospital
city: Hyderabad
country: India
facility: Care Outpatient Centre
city: Hyderabad
country: India
facility: FS Endocrine and Diabetic Centre
city: Hyderabad
country: India
facility: Dr. MV Rama Mohan, MD, DM
city: Jaipur
country: India
facility: Diabetes Thyroid Endocrine Center
city: Kolkata
country: India
facility: Healthy Lifestyle Clinic
city: Kolkata
country: India
facility: Ananda Clinic
city: New Delhi
country: India
facility: Khandelwal Diabetes Thyroid & Endocrinology Clinic
city: Pune
country: India
facility: Chellaram Diabetes Institute
Study officials:
affiliation: Abbott
name: Shivani Acharya
role: STUDY_DIRECTOR
References: