NCT04238559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 17, 2020

Last Update Submit

January 27, 2020

Conditions

Swallowing Difficulties

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • medication adherence assessed by Questionnaire

    5 minutes

Interventions

Self-report questionnaireOTHER

Fill in the SWAMECO questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The project population is the general population.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel

Basel, Canton of Basel-City, 4056, Switzerland

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Isabelle Arnet, Dr.

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 23, 2020

Study Start

February 11, 2019

Primary Completion

April 9, 2019

Study Completion

April 9, 2019

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)