Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis: a Cross-sectional Cohort Study

Conditions
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Systemic Sclerosis, Deglutition Disorders, Adherence to Medication Regime, Coping Behaviour, Scleroderma, Systemic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years diagnosis for systemic sclerosis treated in the Reha Rheinfelden signed informed consent german language skills Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systemic sclerosis<br>Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-reported questionnaire, Swallowing disorders, Systemic sclerosis, Drug therapy, Adherence to medication regime, Coping strategy, Pharmaceutical care, Patient safety, Patient oriented care