Swallowing DifficultiesSWAMECONCT04238559
Use of the SWAMECO Questionnaire Basel
An observational study of Swallowing Difficulties, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing Difficulties
- What is being tested?
- Self-report questionnaire
- How many people
- 115 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Feb 2019to 9 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The project population is the general population.
Who may be able to join
- 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
Who cannot join
- patients who are not able to provide written conformed consent will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Swallowing Difficulties
- Being tested
- Self-report questionnaire
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-report questionnaireOther
Fill in the SWAMECO questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 5 minutes
Secondary outcomes (1)
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?"
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start11 Feb 2019
- Primary completion9 Apr 2019
- Study completion9 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DifficultiesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Arnet, Dr., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238559
- Sponsor's protocol ID
- 2018-02187
- Other IDs
- 2018
- Acronym
- SWAMECO
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the SWAMECO Questionnaire in the General Population to Detect Swallowing Difficulties
- ClinicalTrials.gov ID
- NCT04238559
- Acronym / sponsor ID
- SWAMECO / 2018-02187
- Conditions
- Swallowing Difficulties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The project population is the general population.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- patients who are not able to provide written conformed consent will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-report questionnaireFill in the SWAMECO questionnaire | Other | – |
Primary outcome
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?"
1 secondary outcome
medication adherence assessed by Questionnaire
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Arnet, Dr. principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Swallowing Difficulties, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
swallowing difficulties assessed by Questionnaire (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.