HypothyroidismSTRINCT04784208
A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)
An observational study of Hypothyroidism and Healthy, run by Abbott at 11 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothyroidism, Healthy
- What is being tested?
- Blood test for Thyroid stimulating hormone (TSH)
- How many people
- 232 participants
- Where
- 11 sitesIndia
- Study dates
- 18 Jan 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites, 11 recruiting
- Recruiting
Center for Diabetes and Endocrine care
Bangalore, 560043
Dr.Prasanna Kuamr
- Recruiting
Apollo Excelcare Hospital
Guwahati, 781033
Manash P Baruah, 91-8136018344, manashb2@gmail.com
Manash P Baruah
- Recruiting
Care Outpatient Centre
Hyderabad, 500034
Bipin Sethi, 91-9440739238, endoinformationcare@gmail.com
Bipin Sethi
- Recruiting
FS Endocrine and Diabetic Centre
Hyderabad, 500059
Faraz Farishta, 91-9885035977, drfarazfarishta@gmail.com
Faraz Farishta
- Recruiting
Dr. MV Rama Mohan, MD, DM
Hyderabad
Dr. MV Rama Mohan, MD, DM Kumar
- Not yet recruiting
Diabetes Thyroid Endocrine Center
Jaipur, 302006
Surendra Sharma, 91-9829010233, sksharmacr@gmail.com
Surendra K Sharma
- Recruiting
Healthy Lifestyle Clinic
Kolkata, 700014
Mary D'Cruz, 91-9830152843, drmary91@gmail.com
Mary D'Cruz
- Recruiting
Ananda Clinic
Kolkata, 700034
Debmalya Sanyal, 91-6289855117, drdebmalyasanyal@gmail.com
Debmalya Sanyal
- Recruiting
Diabecare
Mumbai, Maharashtra, 400706
Mahesh V Padsalge, 91-9322509497, drmaheshpadsalge@gmail.com
Mahesh Padsalge
- Recruiting
Khandelwal Diabetes Thyroid & Endocrinology Clinic
New Delhi, 110063
Deepak Khandelwal, '91-9968878561, khandelwalaiims@gmail.com
Deepak Khandelwal
- Recruiting
Chellaram Diabetes Institute
Pune, 411021
Unnikrishnan A Gopalkrishnan, 91-9689287337, uagcdi@cdi.org.in
Unnikrishnan Gopalkrishnan
About this study
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
Read the detailed description
Objectives The objectives of the study are as described in the below points.
- To develop a questionnaire (Q'SHY) for the identification and screening of subjects with suspected hypothyroidism.
- 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.
- 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.
- Subjects are divided into 2 arms, with 100 subjects in each arm.
- 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
- Conditions
- Hypothyroidism, Healthy
- Being tested
- Blood test for Thyroid stimulating hormone (TSH)
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test for Thyroid stimulating hormone (TSH)Diagnostic test
Blood test for Thyroid stimulating hormone (TSH)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: 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
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.
Measured: through out the study upto 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start18 Jan 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shivani Acharya, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784208
- Sponsor's protocol ID
- EPIDI077
- Acronym
- STRI
- Status last verified
- Jul 2022
- First submitted
- 25 Feb 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)
- ClinicalTrials.gov ID
- NCT04784208
- Acronym / sponsor ID
- STRI / EPIDI077
- Conditions
- Hypothyroidism, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- To develop a questionnaire (Q'SHY) for the identification and screening of subjects with suspected hypothyroidism.
- 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.
- 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.
- Subjects are divided into 2 arms, with 100 subjects in each arm.
- 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1-Healthy Volunteers | – | Diagnostic Test: Blood test for Thyroid stimulating hormone (TSH)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 |
| Arm 2- Hypothyroid treatment naïve patients | – | –The subjects will be identified and selected from clinical settings such as hospitals, clinics and certified laboratories. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- Arm 1: Subjects from the general population who are naïve to their hypothyroid status
- The above-mentioned criteria will be applicable to both Face validation and Pilot survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test for Thyroid stimulating hormone (TSH)Blood test for Thyroid stimulating hormone (TSH) | Diagnostic test | Arm 1-Healthy Volunteers |
Primary outcome
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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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Hypothyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shivani Acharya study director
Abbott
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism and Healthy, run by Abbott at 11 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Prasanna Kumar (919845156811, dr.kmpk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.