Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-12 @ 10:30 AM
Study NCT ID:
NCT02105818
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2014-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'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'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-11', 'studyFirstSubmitDate': '2014-03-28', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of the SWAMECO self-report questionnaire', 'timeFrame': 'Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.', 'description': 'Face validation of the questionnaire in a convenience sample of patients with systemic sclerosis.\n\nPercentage of patients who are able to fill out the SWAMECO questionnaire completely and correctly regarding the different types of scales (visual-analog-scale, likert-scale), dichotomous questions (yes / no), and figures to describe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Location and intensity of swallowing difficulties', 'timeFrame': 'Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.', 'description': 'Patients describe location and intensity of swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire'}, {'measure': 'Coping strategies', 'timeFrame': 'Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.', 'description': 'Patients describe coping strategies to avoid swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire'}, {'measure': 'Adherence to medication regimen', 'timeFrame': 'Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.', 'description': 'Patients describe adherence to medication regimen using the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8).'}, {'measure': 'Prevalence of present and/or past swallowing difficulties with medication intake', 'timeFrame': 'Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.', 'description': 'Patients describe present and/or past swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Self-reported questionnaire', 'Swallowing disorders', 'Systemic sclerosis', 'Drug therapy', 'Adherence to medication regime', 'Coping strategy', 'Pharmaceutical care', 'Patient safety', 'Patient oriented care'], 'conditions': ['Systemic Sclerosis', 'Deglutition Disorders', 'Adherence to Medication Regime', 'Coping Behaviour', 'Scleroderma, Systemic']}, 'referencesModule': {'references': [{'pmid': '23963541', 'type': 'BACKGROUND', 'citation': 'Marquis J, Schneider MP, Payot V, Cordonier AC, Bugnon O, Hersberger KE, Arnet I. Swallowing difficulties with oral drugs among polypharmacy patients attending community pharmacies. Int J Clin Pharm. 2013 Dec;35(6):1130-6. doi: 10.1007/s11096-013-9836-2. Epub 2013 Aug 21.'}, {'pmid': '23052416', 'type': 'BACKGROUND', 'citation': 'Schiele JT, Quinzler R, Klimm HD, Pruszydlo MG, Haefeli WE. Difficulties swallowing solid oral dosage forms in a general practice population: prevalence, causes, and relationship to dosage forms. Eur J Clin Pharmacol. 2013 Apr;69(4):937-48. doi: 10.1007/s00228-012-1417-0. Epub 2012 Sep 29.'}], 'seeAlsoLinks': [{'url': 'http://www.pharmacare.unibas.ch', 'label': 'Homepage of the Pharmaceutical Care Research Group, University of Basel, Switzerland'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the validation of a newly developed self-report questionnaire which aims at determining the prevalence, location and intensity of SWAllowing difficulties with drug intake, and describing the impact on MEdication regimen focusing on COping strategies (SWAMECO).', 'detailedDescription': 'The study aims at investigating a cohort of patients with diagnosed systemic sclerosis using the newly developed self-report SWAMECO-questionnaire.\n\nThe self-report questionnaire is sub-divided into four sections: detection of swallowing difficulties, coping strategies, risk factors to develop swallowing difficulties and adherence to medication.\n\nThis study involves patients with systemic sclerosis. Systemic sclerosis often is accompanied by swallowing disorders which may lead to issues in handling medication regimen with risks for patient safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* diagnosis for systemic sclerosis\n* treated in the Reha Rheinfelden\n* signed informed consent\n* german language skills\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02105818', 'acronym': 'SWAMECO', 'briefTitle': 'Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis: a Cross-sectional Cohort Study', 'orgStudyIdInfo': {'id': 'SWAMECO_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Systemic sclerosis', 'description': 'Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4310', 'city': 'Rheinfelden', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Reha Rheinfelden', 'geoPoint': {'lat': 47.55437, 'lon': 7.79403}}], 'overallOfficials': [{'name': 'Kurt Hersberger, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Pharmaceutical Care Research Group, University of Basel, Switzerland'}, {'name': 'Markus Messerli, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pharmaceutical Care Research Group, University of Basel, Switzerland'}, {'name': 'Michael Buslau, PD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reha Rheinfelden, Switzerland'}, {'name': 'Rebecca Wysser, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmaceutical Care Research Group, University of Basel, Switzerland'}, {'name': 'Isabelle Arnet, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmaceutical Care Research Group, University of Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kurt Hersberger', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Basel', 'class': 'OTHER'}, {'name': 'Reha Rheinfelden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kurt Hersberger', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}