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

Completed

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

• Registration Number: NCT02105818
• Lead Sponsor: Kurt Hersberger

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• age >18 years
• diagnosis for systemic sclerosis
• treated in the Reha Rheinfelden
• signed informed consent
• german language skills

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Reha Rheinfelden; 🇨🇭 Rheinfelden, Aargau, Switzerland