Use of the SWAMECO Questionnaire Basel

Swallowing Difficulties Clinical Trial

— SWAMECO  

Official title:

Use of the SWAMECO Questionnaire in the General Population to Detect Swallowing Difficulties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238559
• Other study ID #: 2018-02187
• Status: Completed
• Start date: February 11, 2019
• Est. completion date: April 9, 2019

Study information

• Verified date: January 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 9, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Swallowing Difficulties

Intervention

Other:
• Self-report questionnaire
Fill in the SWAMECO questionnaire

Locations

Country	Name	City	State
Switzerland	University of Basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	swallowing difficulties assessed by Questionnaire	The variable of primary interest is the answer to the question number 4: "Do you experience swallowing difficulties when you take your medicines?"	5 minutes
Secondary	medication adherence assessed by Questionnaire	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?"	5 minutes