Swallowing Difficulties With Medication Intake and Compliance Issues in Patients With Systemic Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Basel, Switzerland
Sponsor:
Collaborators:
University of Basel
Reha Rheinfelden
Information provided by (Responsible Party):
Kurt Hersberger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT02105818
First received: March 28, 2014
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 and COmpliance issues (SWAMECO).


Condition
Systemic Sclerosis [Scleroderma]
Deglutition Disorders
Adherence to Medication Regime
Coping Behaviour

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Swallowing Difficulties With Medication Intake and Compliance Issues in Patients With Systemic Sclerosis: a Cross-sectional Cohort Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Patients describe location and intensity of swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire

  • 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. ] [ Designated as safety issue: No ]
    Patients describe coping strategies to avoid swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire

  • 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. ] [ Designated as safety issue: No ]
    Patients describe adherence to medication regimen using the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8).

  • 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. ] [ Designated as safety issue: No ]
    Patients describe present and/or past swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire


Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Systemic sclerosis
Patients with diagnosed systemic sclerosis treated in the Reha Rheinfelden, Switzerland (European Centre for the Rehabilitation of Scleroderma).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105818

Contacts
Contact: Markus Messerli, MSc +41 61 267 15 29 markus.messerli@unibas.ch

Locations
Switzerland
Reha Rheinfelden Recruiting
Rheinfelden, Aargau, Switzerland, 4310
Contact: Michael Buslau, PD MD    +41 61 836 52 13    m.buslau@reha-rhf.ch   
Contact: Markus Messerli, MSc    +41 61 267 15 29    markus.messerli@unibas.ch   
Principal Investigator: Markus Messerli, MSc         
Principal Investigator: Michael Buslau, PD MD         
Sub-Investigator: Rebecca Wysser, BSc         
Sponsors and Collaborators
Kurt Hersberger
University of Basel
Reha Rheinfelden
Investigators
Study Chair: Kurt Hersberger, Prof Pharmaceutical Care Research Group, University of Basel, Switzerland
Study Director: Markus Messerli, MSc Pharmaceutical Care Research Group, University of Basel, Switzerland
Principal Investigator: 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
  More Information

Additional Information:
Publications:
Responsible Party: Kurt Hersberger, Professor, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02105818     History of Changes
Other Study ID Numbers: SWAMECO_1
Study First Received: March 28, 2014
Last Updated: April 2, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Self-reported questionnaire
Swallowing disorders
Systemic sclerosis
Drug therapy
Adherence to medication regime
Coping strategy
Pharmaceutical care
Patient safety
Patient oriented care

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Deglutition Disorders
Sclerosis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014