Systemic SclerosisSWAMECONCT02105818
Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis
An observational study of Systemic Sclerosis and Deglutition Disorders, run by Kurt Hersberger at 1 site in Switzerland.
Trial summary
The purpose of this study is the validation of a newly developed self-report questionnaire which aims at determining the prevalence, location and intensity of SWAllowing difficulties with drug intake, and describing the impact on MEdication regimen focusing on COping strategies (SWAMECO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Deglutition Disorders, Adherence to Medication Regime
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to Jul 2014
- 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: Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma)
Who may be able to join
- age >18 years
- diagnosis for systemic sclerosis
- treated in the Reha Rheinfelden
- signed informed consent
- german language skills
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis: a Cross-sectional Cohort Study
The purpose of this study is the validation of a newly developed self-report questionnaire which aims at determining the prevalence, location and intensity of SWAllowing difficulties with drug intake, and describing the impact on MEdication regimen focusing on COping strategies (SWAMECO).
Read the detailed description
The study aims at investigating a cohort of patients with diagnosed systemic sclerosis using the newly developed self-report SWAMECO-questionnaire.
The self-report questionnaire is sub-divided into four sections: detection of swallowing difficulties, coping strategies, risk factors to develop swallowing difficulties and adherence to medication.
This study involves patients with systemic sclerosis. Systemic sclerosis often is accompanied by swallowing disorders which may lead to issues in handling medication regimen with risks for patient safety.
- Conditions
- Systemic Sclerosis, Deglutition Disorders, Adherence to Medication Regime, Coping Behaviour, Scleroderma, Systemic
- Keywords
- Self-reported questionnaire, Swallowing disorders, Systemic sclerosis, Drug therapy, Adherence to medication regime, Coping strategy, Pharmaceutical care, Patient safety, Patient oriented care
- Medical subject headings
- Scleroderma, Systemic, Deglutition Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis | Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the SWAMECO self-report questionnaire
Face validation of the questionnaire in a convenience sample of patients with systemic sclerosis.
Percentage of patients who are able to fill out the SWAMECO questionnaire completely and correctly regarding the different types of scales (visual-analog-scale, likert-scale), dichotomous questions (yes / no), and figures to describe symptoms.
Measured: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
Secondary outcomes (4)
Location and intensity of swallowing difficulties
Patients describe location and intensity of swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire
Measured: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
Coping strategies
Patients describe coping strategies to avoid swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire
Measured: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
Adherence to medication regimen
Patients describe adherence to medication regimen using the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8).
Measured: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
Prevalence of present and/or past swallowing difficulties with medication intake
Patients describe present and/or past swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire
Measured: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kurt Hersberger
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Reha Rheinfelden
- Responsible party
- Sponsor-investigator, Kurt Hersberger, University Hospital, Basel, Switzerland
- Investigators
- Kurt Hersberger, Prof, Study chair, Pharmaceutical Care Research Group, University of Basel, SwitzerlandMarkus Messerli, MSc, Study director, Pharmaceutical Care Research Group, University of Basel, SwitzerlandMichael Buslau, PD MD, Principal investigator, Reha Rheinfelden, SwitzerlandRebecca Wysser, BSc, Principal investigator, Pharmaceutical Care Research Group, University of Basel, SwitzerlandIsabelle Arnet, PhD, Principal investigator, Pharmaceutical Care Research Group, University of Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105818
- Sponsor's protocol ID
- SWAMECO_1
- Acronym
- SWAMECO
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2014
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Marquis J, Schneider MP, Payot V, Cordonier AC, Bugnon O, Hersberger KE, Arnet I. Swallowing difficulties with oral drugs among polypharmacy patients attending community pharmacies. Int J Clin Pharm. 2013 Dec;35(6):1130-6. doi: 10.1007/s11096-013-9836-2. Epub 2013 Aug 21.
PubMed 23963541Schiele JT, Quinzler R, Klimm HD, Pruszydlo MG, Haefeli WE. Difficulties swallowing solid oral dosage forms in a general practice population: prevalence, causes, and relationship to dosage forms. Eur J Clin Pharmacol. 2013 Apr;69(4):937-48. doi: 10.1007/s00228-012-1417-0. Epub 2012 Sep 29.
PubMed 23052416
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis: a Cross-sectional Cohort Study
- ClinicalTrials.gov ID
- NCT02105818
- Acronym / sponsor ID
- SWAMECO / SWAMECO_1
- Conditions
- Systemic Sclerosis, Deglutition Disorders, Adherence to Medication Regime, Coping Behaviour, Scleroderma, Systemic
- Keywords
- Self-reported questionnaire, Swallowing disorders, Systemic sclerosis, Drug therapy, Adherence to medication regime, Coping strategy, Pharmaceutical care, Patient safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kurt HersbergerUniversity, hospital or other
- Collaborators
- University of Basel, Reha Rheinfelden
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 7 Apr 2014 (estimated)
- 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.
The purpose of this study is the validation of a newly developed self-report questionnaire which aims at determining the prevalence, location and intensity of SWAllowing difficulties with drug intake, and describing the impact on MEdication regimen focusing on COping strategies (SWAMECO).
Detailed description
The study aims at investigating a cohort of patients with diagnosed systemic sclerosis using the newly developed self-report SWAMECO-questionnaire.
The self-report questionnaire is sub-divided into four sections: detection of swallowing difficulties, coping strategies, risk factors to develop swallowing difficulties and adherence to medication.
This study involves patients with systemic sclerosis. Systemic sclerosis often is accompanied by swallowing disorders which may lead to issues in handling medication regimen with risks for patient safety.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis | – | –Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma)
Key inclusion criteria (5 listed)
- age >18 years
- diagnosis for systemic sclerosis
- treated in the Reha Rheinfelden
- signed informed consent
- german language skills
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of the SWAMECO self-report questionnaire
Time frame: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
Face validation of the questionnaire in a convenience sample of patients with systemic sclerosis. Percentage of patients who are able to fill out the SWAMECO questionnaire completely and correctly regarding the different types of scales (visual-analog-scale, likert-scale), dichotomous questions (yes / no), and figures to describe symptoms.
4 secondary outcomes
Location and intensity of swallowing difficulties
Time frame: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
Coping strategies
Time frame: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
Adherence to medication regimen
Time frame: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
Prevalence of present and/or past swallowing difficulties with medication intake
Time frame: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
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 13 Apr 2017.
- Background: PubMed 23963541Marquis J, Schneider MP, Payot V, Cordonier AC, Bugnon O, Hersberger KE, Arnet I. Swallowing difficulties with oral drugs among polypharmacy patients attending community pharmacies. Int J Clin Pharm. 2013 Dec;35(6):1130-6. doi: 10.1007/s11096-013-9836-2. Epub 2013 Aug 21.
- Background: PubMed 23052416Schiele JT, Quinzler R, Klimm HD, Pruszydlo MG, Haefeli WE. Difficulties swallowing solid oral dosage forms in a general practice population: prevalence, causes, and relationship to dosage forms. Eur J Clin Pharmacol. 2013 Apr;69(4):937-48. doi: 10.1007/s00228-012-1417-0. Epub 2012 Sep 29.
- Homepage of the Pharmaceutical Care Research Group, University of Basel, SwitzerlandLink provided by the sponsor.
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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.
Kurt Hersberger, Prof study chair
Pharmaceutical Care Research Group, University of Basel, Switzerland
Markus Messerli, MSc study director
Pharmaceutical Care Research Group, University of Basel, Switzerland
Michael Buslau, PD MD principal investigator
Reha Rheinfelden, Switzerland
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 Systemic Sclerosis and Deglutition Disorders, run by Kurt Hersberger 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 5 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 13 Apr 2017. 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?
Validation of the SWAMECO self-report questionnaire (time frame: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02105818, which also lists 2 linked publications.
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 13 Apr 2017.