Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-24 @ 4:00 AM
Study NCT ID:
NCT04238559
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2020-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of the SWAMECO Questionnaire Basel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2020-01-17', 'studyFirstSubmitQcDate': '2020-01-20', 'lastUpdatePostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'swallowing difficulties assessed by Questionnaire', 'timeFrame': '5 minutes', 'description': 'The variable of primary interest is the answer to the question number 4: "Do you experience swallowing difficulties when you take your medicines?"'}], 'secondaryOutcomes': [{'measure': 'medication adherence assessed by Questionnaire', 'timeFrame': '5 minutes', 'description': 'Answers to q 26-28: "how many days did you miss at least one dose of any of your medicines?", "how good a job did you do at taking your medicines in the way you were supposed to?", "how often did you take your medicines in the way you were supposed to?"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Swallowing Difficulties']}, 'descriptionModule': {'briefSummary': 'A patient self-report questionnaire was developed that assesses subjective swallowing difficulties with medication intake, the SWAMECO questionnaire. It was validated in a highly specific population and will now be tested in the general population.', 'detailedDescription': 'Based on a systematic literature review, a novel self-report questionnaire was developed in 2016 to assess subjective swallowing difficulties with medication intake and their practical consequences in ambulatory patients, the SWAMECO questionnaire. It consists of 30 items divided into 5 sections Complaints, Intensity, Localization, Coping strategies, and Adherence to medication. It was validated in people suffering from systemic sclerosis (SSc), a rare multisystem autoimmune disease that often leads to swallowing problems with food and liquids with progression. The aim of this study is now to validate the questionnaire in the general population. Patients presenting in the community pharmacy with a prescription of at least 3 different medications for a minimum of 3 months will fill in the questionnaire on site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The project population is the general population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years or more\n* is living in the community setting\n* is receiving three or more medications for a period not less than three months, independently of the frequency of the intake\n\nExclusion Criteria:\n\n* patients who are not able to provide written conformed consent will be excluded'}, 'identificationModule': {'nctId': 'NCT04238559', 'acronym': 'SWAMECO', 'briefTitle': 'Use of the SWAMECO Questionnaire Basel', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Use of the SWAMECO Questionnaire in the General Population to Detect Swallowing Difficulties', 'orgStudyIdInfo': {'id': '2018-02187'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Self-report questionnaire', 'type': 'OTHER', 'description': 'Fill in the SWAMECO questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Isabelle Arnet, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}