Clinical trial NCT02105818: Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis
Official title: Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis: a Cross-sectional Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Reha Rheinfelden
First posted: 2014-04-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma)

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* diagnosis for systemic sclerosis
* treated in the Reha Rheinfelden
* signed informed consent
* german language skills

Exclusion Criteria:

-

Primary outcomes:
measure: Validation of the SWAMECO self-report questionnaire
timeFrame: 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:
measure: Location and intensity of swallowing difficulties
timeFrame: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
measure: Coping strategies
timeFrame: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
measure: Adherence to medication regimen
timeFrame: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
measure: Prevalence of present and/or past swallowing difficulties with medication intake
timeFrame: Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Reha Rheinfelden
state: Aargau
Study officials:
affiliation: Pharmaceutical Care Research Group, University of Basel, Switzerland
name: Kurt Hersberger, Prof
role: STUDY_CHAIR
affiliation: Pharmaceutical Care Research Group, University of Basel, Switzerland
name: Markus Messerli, MSc
role: STUDY_DIRECTOR
affiliation: Reha Rheinfelden, Switzerland
name: Michael Buslau, PD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pharmaceutical Care Research Group, University of Basel, Switzerland
name: Rebecca Wysser, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Pharmaceutical Care Research Group, University of Basel, Switzerland
name: Isabelle Arnet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Schiele 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.