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NCT Number: NCT04238559

Use of the SWAMECO Questionnaire Basel

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.

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Key information

Conditions

Swallowing Difficulties Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Basel

Basel, Canton of Basel-City, 4056, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-report questionnaire

Other

Fill in the SWAMECO questionnaire

Primary outcomes

  1. 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?"

Secondary outcomes

  1. 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?"

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: SWAMECO

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2020
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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