Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 3:36 PM
Study NCT ID:
NCT04879095
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2021-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-26', 'studyFirstSubmitDate': '2021-05-04', 'studyFirstSubmitQcDate': '2021-05-04', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Translation of Dyspnea 12 in Urdu version', 'timeFrame': '4 Week', 'description': "D12 scale is used in assessment of dyspnea severity using its descriptors consist of sensory quality and effective component. It's a 12 item scale from 1-7 item related to physical component score (quality of sensation of dyspnea) \\& from 8-12 related to emotional response of this sensation. Each item was graded on 4 point scale as none, mild, moderate \\& severe and scored as 0 to 3 to get final score of 0 to 36\n\n* Forward conversion\n* Professional panel\n* Backward conversion\n* Pretesting\n* Final Form The translation of Dyspnea12 (D-12) Questionnaire into Urdu was done by using Cross Cultural Adaptation techniques according to WHO guideline it involve the following steps\n* Forward conversion\n* Professional panel\n* Backward conversion\n* Pretesting\n* Final Form"}], 'secondaryOutcomes': [{'measure': 'Six minute Walk test', 'timeFrame': '4 week', 'description': 'It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as outcome by which to compare changes in performance capacity. 30-metre stretch of unimpeded walkway is used and patient is instructed to walk as far as possible for 6 minutes. Test retest reliability of 6MWT showed good internal consistency (ICC=0.9) in patients with heart failure patients'}, {'measure': 'Rate Perceived Exertion', 'timeFrame': '4 week', 'description': 'The scale is used to monitor and guide exercise intensity and help in measure how hard your body is working when you exercise. It gives estimate of your heart rate and exercise intensity zone. The scale ranges from 6 -20. 6 indicate no exertion and 20 denotes maximum exertion, it is simple numerical list.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body mass index (BMI)', 'Rate of perceived exertion (RPE)', '6 minute walk test (^MWT)'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'Dyspnea is a distressing symptom with pain like perception. The object of study is to translate a tool that measure overall dyspnea severity. Although many scales are available to assess dyspnea but D12 is a clear reliable scale and is use full in clinical practice to assess dyspnea in terms of intensity, quality and emotional response.', 'detailedDescription': 'Aim of study is to translate a clinical validate of Urdu version of D-12 in COPDs patients. The study will measure reliability \\& validity of dyspnea in Urdu version. No study has been conducted in our region to translate D-12 follow the proper cross culture adaptation. Therefor the instrument will translate in our language adapting proper cross culture guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age between 40-65 with diagnosis of COPD\n* Outpatient individual who are on follow up\n* Healthy individual\n* Those who can read and understand English and Urdu as well.\n\nExclusion Criteria:\n\n* Patient with cognitive impairment or sensory disorder were exclude.\n* Patient physical disability\n* Refuse to perform test'}, 'identificationModule': {'nctId': 'NCT04879095', 'briefTitle': 'Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)', 'orgStudyIdInfo': {'id': 'REC00780 Mehwish Shabbir'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hyderābād', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Civil Hospital', 'geoPoint': {'lat': 25.39689, 'lon': 68.37718}}], 'overallOfficials': [{'name': 'sumaiyah Obaid, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}