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Completed

NCT Number: NCT02105818

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

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).

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Key information

Conditions

Systemic Sclerosis Adherence to Medication Regime Behavior Connective Tissue Diseases Coping Behaviour Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Health Behavior Medication Adherence Otorhinolaryngologic Diseases Patient Acceptance of Health Care Patient Compliance Pharyngeal Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Patients describe location and intensity of swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire

  2. 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.

    Patients describe coping strategies to avoid swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire

  3. 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.

    Patients describe adherence to medication regimen using the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8).

  4. 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.

    Patients describe present and/or past swallowing difficulties with medication intake by filling the SWAMECO self-report questionnaire

Sponsors and collaborators

Lead sponsor

Kurt Hersberger

Other

Collaborators

  • Reha Rheinfelden
  • University of Basel

Registry information

Official study title

Swallowing Difficulties With Medication Intake and Coping Strategies in Patients With Systemic Sclerosis: a Cross-sectional Cohort Study

Acronym: SWAMECO

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 7, 2014
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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