Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis

NCT02105818 | Completed

• 1 other identifier: SWAMECO_1
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  Eligible patients will be asked to answer the questionnaire at the time of enrolment (cross-sectional), return of all questionnaires within 4 weeks.

Study Arms (1)

Systemic sclerosis

Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

Sponsors & Collaborators

• Kurt Hersberger: lead
• University of Basel: collaborator
• Reha Rheinfelden: collaborator

Study Sites (1)

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 23963541 BACKGROUND

• 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.

  PMID: 23052416 BACKGROUND

Related Links

• Homepage of the Pharmaceutical Care Research Group, University of Basel, Switzerland

MeSH Terms

Conditions

Scleroderma, Systemic; Deglutition Disorders; Medication Adherence

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kurt Hersberger, Prof

  Pharmaceutical Care Research Group, University of Basel, Switzerland

  STUDY CHAIR

• Markus Messerli, MSc

  Pharmaceutical Care Research Group, University of Basel, Switzerland

  STUDY DIRECTOR

• Michael Buslau, PD MD

  Reha Rheinfelden, Switzerland

  PRINCIPAL INVESTIGATOR

• Rebecca Wysser, BSc

  Pharmaceutical Care Research Group, University of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Isabelle Arnet, PhD

  Pharmaceutical Care Research Group, University of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 7, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

CH (1)