Use of the SWAMECO Questionnaire Basel (SWAMECO)

January 27, 2020 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4056
        • University of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The project population is the general population.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
swallowing difficulties assessed by Questionnaire
Time Frame: 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?"
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
medication adherence assessed by Questionnaire
Time Frame: 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?"
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Isabelle Arnet, Dr., University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 11, 2019

Primary Completion (ACTUAL)

April 9, 2019

Study Completion (ACTUAL)

April 9, 2019

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 20, 2020

First Posted (ACTUAL)

January 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-02187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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