Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT04784208
Status:
UNKNOWN
Last Update Posted:
2022-07-13
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 232}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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'}, {'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', 'description': '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'}, {'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', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypothyroidism', 'Healthy']}, 'descriptionModule': {'briefSummary': "Type of Study Questionnaire- Development and validation\n\nInformation about the Q'SHY:\n\n* The Q'SHY- Questionnaire for Screening of Hypothyroidism is a Patient Reported Outcome (PRO) tool to enable screening for Hypothyroidism in the general population.\n* 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.\n* The questionnaire content is being created based on a thorough search for relevant literature and encompasses all important aspects for screening purposes", 'detailedDescription': "Objectives The objectives of the study are as described in the below points.\n\n1. To develop a questionnaire (Q'SHY) for the identification and screening of subjects with suspected hypothyroidism.\n2. 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.\n3. The study aims to establish a valid questionnaire with a robust sensitivity and specificity to detect signs and symptoms of hypothyroidism.\n\nInclusion 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.\n\n* Male and female subjects between the age of 18 years and 65 years\n* Willing to sign the Subject Authorization Form (SAF) Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve\\*.\n* Male and female subjects between the ages 18 years and 65 years.\n* 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\n* Willing to sign the SAF\n* 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\n\nExclusion criteria for subjects Arm 1: Subjects from the general population who are naïve to their hypothyroid status\n\n* Individuals less than 18 years of age and more than 65 years of age.\n* Pregnant or lactating females Subjects previously diagnosed with and received treatment for thyroid diseases.\n* Subjects not willing to sign the SAF.\n\nArm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve\n\n* Individuals less than 18 years of age and more than 65 years of age.\n* Pregnant or lactating females\n* Subjects previously diagnosed with and received treatment for thyroid diseases.\n* Patients on treatment for Thyroid diseases Subjects not willing to sign the SAF.\n\nThe above-mentioned criteria will be applicable to both Face validation and Pilot survey.\n\n1. Subjects are divided into 2 arms, with 100 subjects in each arm.\n2. Phase -1\n\n * Arm 1: Sixteen subjects from the general population who are naïve to their hypothyroid status with equal distribution of males and females.\n * Arm 2: Sixteen subjects who are newly diagnosed patients of Hypothyroidism are treatment naïve with equal distribution of males and females\n3. Phase -2\n\n * Arm 1: One hundred subjects from the general population who are naïve to their hypothyroid status with equal distribution of males and females\n * Arm 2: One hundred subjects who are newly diagnosed patients of Hypothyroidism are treatment naïve with equal distribution of males and females"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Phase -1\n\n* Arm 1: Sixteen subjects from the general population who are naïve to their hypothyroid status with equal distribution of males and females.\n* Arm 2: Sixteen subjects who are newly diagnosed patients of Hypothyroidism are treatment naïve with equal distribution of males and females\n\nPhase -2\n\n* Arm 1: One hundred subjects from the general population who are naïve to their hypothyroid status with equal distribution of males and females\n* Arm 2: One hundred subjects who are newly diagnosed patients of Hypothyroidism are treatment naïve with equal distribution of males and females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\n * Male and female subjects between the age of 18 years and 65 years\n * Willing to sign the Subject Authorization Form (SAF) Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve\\*.\n * Male and female subjects between the ages 18 years and 65 years.\n * 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\n * Willing to sign the SAF\n * 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\n\nExclusion Criteria:\n\n* Arm 1: Subjects from the general population who are naïve to their hypothyroid status\n\n * Individuals less than 18 years of age and more than 65 years of age.\n * Pregnant or lactating females\n * Subjects previously diagnosed with and received treatment for thyroid diseases.\n * Subjects not willing to sign the SAF. Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve\n * Individuals less than 18 years of age and more than 65 years of age.\n * Pregnant or lactating females\n * Subjects previously diagnosed with and received treatment for thyroid diseases.\n * Patients on treatment for Thyroid diseases Subjects not willing to sign the SAF.\n\nThe above-mentioned criteria will be applicable to both Face validation and Pilot survey.'}, 'identificationModule': {'nctId': 'NCT04784208', 'acronym': 'STRI', 'briefTitle': "A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': "A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY)", 'orgStudyIdInfo': {'id': 'EPIDI077'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1-Healthy Volunteers', 'description': 'Arm 1: Subjects from the general population who are naïve to their hypothyroid status.\n\nThe 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', 'interventionNames': ['Diagnostic Test: Blood test for Thyroid stimulating hormone (TSH)']}, {'label': 'Arm 2- Hypothyroid treatment naïve patients', 'description': 'The subjects will be identified and selected from clinical settings such as hospitals, clinics and certified laboratories.'}], 'interventions': [{'name': 'Blood test for Thyroid stimulating hormone (TSH)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood test for Thyroid stimulating hormone (TSH)', 'armGroupLabels': ['Arm 1-Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400706', 'city': 'Mumbai', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Mahesh V Padsalge', 'role': 'CONTACT', 'email': 'drmaheshpadsalge@gmail.com', 'phone': '91-9322509497'}, {'name': 'Mahesh Padsalge', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Diabecare', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '560043', 'city': 'Bangalore', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr.Prasanna Kuamr', 'role': 'CONTACT'}], 'facility': 'Center for Diabetes and Endocrine care', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '781033', 'city': 'Guwahati', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Manash P Baruah', 'role': 'CONTACT', 'email': 'manashb2@gmail.com', 'phone': '91-8136018344'}, {'name': 'Manash P Baruah', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Apollo Excelcare Hospital', 'geoPoint': {'lat': 26.1844, 'lon': 91.7458}}, {'zip': '500034', 'city': 'Hyderabad', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Bipin Sethi', 'role': 'CONTACT', 'email': 'endoinformationcare@gmail.com', 'phone': '91-9440739238'}, {'name': 'Bipin Sethi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Care Outpatient Centre', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500059', 'city': 'Hyderabad', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Faraz Farishta', 'role': 'CONTACT', 'email': 'drfarazfarishta@gmail.com', 'phone': '91-9885035977'}, {'name': 'Faraz Farishta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FS Endocrine and Diabetic Centre', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Hyderabad', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr. MV Rama Mohan, MD, DM Kumar', 'role': 'CONTACT'}], 'facility': 'Dr. MV Rama Mohan, MD, DM', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '302006', 'city': 'Jaipur', 'status': 'NOT_YET_RECRUITING', 'country': 'India', 'contacts': [{'name': 'Surendra Sharma', 'role': 'CONTACT', 'email': 'sksharmacr@gmail.com', 'phone': '91-9829010233'}, {'name': 'Surendra K Sharma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Diabetes Thyroid Endocrine Center', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '700014', 'city': 'Kolkata', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': "Mary D'Cruz", 'role': 'CONTACT', 'email': 'drmary91@gmail.com', 'phone': '91-9830152843'}, {'name': "Mary D'Cruz", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Healthy Lifestyle Clinic', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '700034', 'city': 'Kolkata', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Debmalya Sanyal', 'role': 'CONTACT', 'email': 'drdebmalyasanyal@gmail.com', 'phone': '91-6289855117'}, {'name': 'Debmalya Sanyal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ananda Clinic', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '110063', 'city': 'New Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Deepak Khandelwal', 'role': 'CONTACT', 'email': 'khandelwalaiims@gmail.com', 'phone': "'91-9968878561"}, {'name': 'Deepak Khandelwal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Khandelwal Diabetes Thyroid & Endocrinology Clinic', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '411021', 'city': 'Pune', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Unnikrishnan A Gopalkrishnan', 'role': 'CONTACT', 'email': 'uagcdi@cdi.org.in', 'phone': '91-9689287337'}, {'name': 'Unnikrishnan Gopalkrishnan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chellaram Diabetes Institute', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}], 'centralContacts': [{'name': 'Dr Prasanna Kumar', 'role': 'CONTACT', 'email': 'dr.kmpk@gmail.com', 'phone': '919845156811'}], 'overallOfficials': [{'name': 'Shivani Acharya', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}