Adherence to Medication Regime, Coping Behaviour, Deglutition Disorders, Scleroderma, Systemic, Systemic Sclerosis
Conditions
Keywords
Self-reported questionnaire, Swallowing disorders, Systemic sclerosis, Drug therapy, Adherence to medication regime, Coping strategy, Pharmaceutical care, Patient safety, Patient oriented care
Brief summary
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
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.
Interventions
None listed
Sponsors
University of Basel
Reha Rheinfelden
Kurt Hersberger
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 years * diagnosis for systemic sclerosis * treated in the Reha Rheinfelden * signed informed consent * german language skills
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Location and intensity of swallowing difficulties | Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks. | Patients describe location and intensity of swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire |
| Coping strategies | Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks. | Patients describe coping strategies to avoid swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire |
| Adherence to medication regimen | Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks. | Patients describe adherence to medication regimen using the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). |
| Prevalence of present and/or past swallowing difficulties with medication intake | Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks. | Patients describe present and/or past swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire |
Countries
Switzerland
Outcome results
None listed