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

Systemic Sclerosis Clinical Trial

— SWAMECO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105818
• Other study ID #: SWAMECO_1
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: April 11, 2017
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: April 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age >18 years

• diagnosis for systemic sclerosis

• treated in the Reha Rheinfelden

• signed informed consent

• german language skills

Exclusion Criteria:

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Switzerland	Reha Rheinfelden	Rheinfelden	Aargau

Sponsors (3)

Lead Sponsor	Collaborator
Kurt Hersberger	Reha Rheinfelden, University of Basel

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Homepage of the Pharmaceutical Care Research Group, University of Basel, Switzerland