Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-01 @ 8:51 PM
Study NCT ID:
NCT05036057
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turkish Version of the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001519', 'term': 'Behavior'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}, 'targetDuration': '15 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-10-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD)', 'timeFrame': 'Baseline', 'description': 'The scale is a 34-item questionnaire that evaluates the knowledge of COPD patients and their relatives about the disease and general health.\n\nAll of 34 statements can be answered as "true", "false" or "don\'t know". A score out of 34 points will be obtained by giving 1 point to each correct answer appropriate to the question.\n\nHigher score will show more knowledge level. It will done by patients and their proxies.'}], 'secondaryOutcomes': [{'measure': 'COPD Assesment Test (CAT)', 'timeFrame': 'Baseline', 'description': "The COPD Assessment Test (CAT) is a questionnaire, which consist of 8 questions, for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The eight questions are each rated on a scale of 0 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. It will done by patients."}, {'measure': 'The modified Medical Research Council (mMRC) scale', 'timeFrame': 'Baseline', 'description': 'The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.\n\nIt will done by patients.'}, {'measure': 'Charlson Comorbidity Index', 'timeFrame': 'Baseline', 'description': 'The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.'}, {'measure': "The St George's Respiratory Questionnaire (SGRQ)", 'timeFrame': 'Baseline', 'description': "The St George's Respiratory Questionnaire (SGRQ) is a validated, commonly used questionnaire for measuring quality of life in patients with chronic obstructive pulmonary disease (COPD). It consists of 76 items in three domains (symptoms, activity, impact of disease on daily life).\n\nA total score of SGRQ is calculated from 0 (no health impairment) to 100 (maximum health impairment). There are also the score of each domain are scored from 0 to 100."}, {'measure': 'Knowledge Score 0-10 Numerical Rating', 'timeFrame': 'Baseline', 'description': 'The 11-point numeric scale ranges from \'0\' (e.g. "nothing known") to \'10\' (e.g. "maximal knowledge").\n\nIt can be administered verbally. Scores range from 0-10 points, with higher scores indicating greater knowledge. It will done by patients and their proxies. They will be asked to rate their level of knowledge about COPD and general health.'}, {'measure': 'The Sociodemographic Characteristics', 'timeFrame': 'Baseline', 'description': 'The sociodemographic characteristics of the patient and their relatives will be recorded in the registration form.\n\nSocio-demographic information will be asked from people and their relatives by mutual interview method.\n\nAge, gender, marital status, education level, occupation, medical history, duration of COPD, regularly used medications - oxygen support - non-invasive mechanical ventilation (NIMV), smoking status, alcohol consumption, exercise habits, attacks and pulmonary rehabilitation histories will be questioned in this section.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'patient knowledge', 'proxies'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Knowledge, Attitudes, Practice']}, 'descriptionModule': {'briefSummary': 'The Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) Patient and Resident Proxies questionnaire, which can be used in patients with Chronic Obstructive Pulmonary Disease (COPD) and their relatives, will be adapted into Turkish and its psychometric properties will be examined, and the knowledge level of patients and their relatives about the disease and general health will be investigated.', 'detailedDescription': 'The socio-demographic characteristics of the patients and their relatives will be obtained by asking to them by mutual interview method.\n\nA disease-specific test, the COPD Assessment Test (CAT), will be used to assess patients\' own health, and the St George Respiratory Questionnaire (SGRQ) will be used to assess patients\' quality of life.\n\nComorbidities reported by the patient and their relatives will be filled in the Charlson Comorbidity Index. The dyspnea that patients encounter in their daily lives will be questioned with the Modified Medical Research Council (mMRC) Dyspnea Scale.\n\nThe "Individual Knowledge Statements of Patients and Resident Proxies" will be used for the individual information of the patient and their relatives about the disease and general health.\n\nThere is no control group in the study. SGRQ, CAT and numerical rating scale will be used for the validity of the Turkish version of Individual Knowledge Statements of Patients and Resident Proxies. For the test-retest, the evaluation will be done again after 15 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be patient with diagnosed COPD in the Chest Diseases Outpatient Clinic of Dr Suat Seren Chest Diseases and Surgery Training and Research Hospital, and their proxies.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being 18 years or older\n* Being diagnosed with COPD by a specialist physician (for patients)\n* Being clinically stable (For patients, no history of hospital admission/hospitalization due to exacerbation in the last 4 weeks)\n* Having information about the diagnosis (For patients)\n* To read, write and understand Turkish\n* Volunteering to participate in the study\n* Being a proxy of the patient (living with the patient regardless of whether they are providing care or not)\n\nExclusion Criteria:\n\n* Having musculoskeletal, neurological, cardiac, and/or cognitive problems other than COPD, which may create a caregiver burden for the patient's relative"}, 'identificationModule': {'nctId': 'NCT05036057', 'briefTitle': 'Turkish Version of the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'Investigation of the Psychometric Properties of the Turkish Version of the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) Patient and Resident Proxies', 'orgStudyIdInfo': {'id': '2021-GOKAE-0221'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD patients and their proxies', 'description': 'Patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD), the COPD Assesment Test (CAT), the Saint George Respiratory Disease Questionnaire (SGRQ), the Charlson Comorbidity Index, and will rate the disease and general knowledge level on a numerical scale.\n\nProxies of patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) and will rate the disease and general knowledge level on a numerical scale.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD), the COPD Assesment Test (CAT), the Saint George Respiratory Disease Questionnaire (SGRQ), the Charlson Comorbidity Index, and will rate the disease and general knowledge level on a numerical scale.\n\nProxies of patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) and will rate the disease and general knowledge level on a numerical scale.', 'armGroupLabels': ['COPD patients and their proxies']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ilknur Naz', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}