Use of the SWAMECO Questionnaire Basel

Completed

• Conditions: Swallowing Difficulties

• Registration Number: NCT04238559
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

A patient self-report questionnaire was developed that assesses subjective swallowing difficulties with medication intake, the SWAMECO questionnaire. It was validated in a highly specific population and will now be tested in the general population.

Detailed Description

Based on a systematic literature review, a novel self-report questionnaire was developed in 2016 to assess subjective swallowing difficulties with medication intake and their practical consequences in ambulatory patients, the SWAMECO questionnaire. It consists of 30 items divided into 5 sections Complaints, Intensity, Localization, Coping strategies, and Adherence to medication. It was validated in people suffering from systemic sclerosis (SSc), a rare multisystem autoimmune disease that often leads to swallowing problems with food and liquids with progression. The aim of this study is now to validate the questionnaire in the general population. Patients presenting in the community pharmacy with a prescription of at least 3 different medications for a minimum of 3 months will fill in the questionnaire on site.

Study Timeline

• Study Start: 2019-02-11
• Primary Completion: 2019-04-09
• Study Completion: 2019-04-09
• Status Verified: 2020-01
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-23
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• aged 18 years or more
• is living in the community setting
• is receiving three or more medications for a period not less than three months, independently of the frequency of the intake

Exclusion Criteria

• patients who are not able to provide written conformed consent will be excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
swallowing difficulties assessed by Questionnaire	5 minutes	The variable of primary interest is the answer to the question number 4: "Do you experience swallowing difficulties when you take your medicines?"

Secondary Outcome Measures

Name	Time	Method
medication adherence assessed by Questionnaire	5 minutes	Answers to q 26-28: "how many days did you miss at least one dose of any of your medicines?", "how good a job did you do at taking your medicines in the way you were supposed to?", "how often did you take your medicines in the way you were supposed to?"

Trial Locations

Locations (1)

University of Basel; 🇨🇭 Basel, Basel Stadt, Switzerland