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| Name | Class |
|---|---|
| University of Basel | OTHER |
| Reha Rheinfelden | OTHER |
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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).
The study aims at investigating a cohort of patients with diagnosed systemic sclerosis using the newly developed self-report SWAMECO-questionnaire.
The 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.
This 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic sclerosis | Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma). |
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| Measure | Description | Time Frame |
|---|---|---|
| Validation of the SWAMECO self-report questionnaire | Face validation of the questionnaire in a convenience sample of patients with systemic sclerosis. Percentage 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. | Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Location and intensity of swallowing difficulties | Patients describe location and intensity of swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire | Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma)
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Hersberger, Prof | Pharmaceutical Care Research Group, University of Basel, Switzerland | Study Chair |
| Markus Messerli, MSc | Pharmaceutical Care Research Group, University of Basel, Switzerland | Study Director |
| Michael Buslau, PD MD | Reha Rheinfelden, Switzerland | Principal Investigator |
| Rebecca Wysser, BSc | Pharmaceutical Care Research Group, University of Basel, Switzerland | Principal Investigator |
| Isabelle Arnet, PhD | Pharmaceutical Care Research Group, University of Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reha Rheinfelden | Rheinfelden | Canton of Aargau | 4310 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23963541 | Background | 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. | |
| 23052416 | Background | 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. |
| Label | URL |
|---|---|
| Homepage of the Pharmaceutical Care Research Group, University of Basel, Switzerland | View source |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D003680 | Deglutition Disorders |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D004935 | Esophageal Diseases |
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| Coping strategies |
Patients describe coping strategies to avoid swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire |
| Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks. |
| Adherence to medication regimen | Patients describe adherence to medication regimen using the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). | Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks. |
| Prevalence of present and/or past swallowing difficulties with medication intake | Patients describe present and/or past swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire | Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks. |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |