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Clinical Trials/NCT03897231
NCT03897231
Completed
Not Applicable

Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis - a Multicenter Cross-sectional Study

Rigshospitalet, Denmark1 site in 1 country385 target enrollmentMay 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Medication Adherence
Sponsor
Rigshospitalet, Denmark
Enrollment
385
Locations
1
Primary Endpoint
the Morisky-Green-Levine scale (MAQ)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Background:

Non-adherence to medication among patients on chronic hemodialysis compromises treatment effects and results in increased morbidity, mortality and extensive costs to the healthcare system. To our knowledge, no studies have investigated the prevalence of non-adherence among Danish hemodialysis patients using a validated measure of non-adherence.

Aim:

The primary aim of this study was to investigate the prevalence of non-adherence among Danish patients on chronic hemodialysis measured by self-report.

Our second aim was to explore patients' beliefs about medicines and potential associations between beliefs and non-adherence to medication.

Our third aim was to explore the prevalence and severity of physical and emotional symptoms and potential associations with non-adherence to medication.

Design:

A multi-centre cross-sectional study according to the STROBE statement will be conducted from May 2019 - April 2021. The study will take place in the outpatient hemodialysis centres at three large University Hospitals in the Capital Region of Denmark.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
January 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bo Feldt-Rasmussen

Professor

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of end stage kidney disease
  • Must have received hemodialysis treatment ≥3 month at a hospital-based outpatient hemodialysis Centre
  • Must be able to understand and speak Danish

Exclusion Criteria

  • cognitive impairment
  • no current medication prescriptions

Outcomes

Primary Outcomes

the Morisky-Green-Levine scale (MAQ)

Time Frame: up to 8 months

number of participants with non-adherence to medication assessed by scores of ≥1 indicating non-adherence

Medication adherence report scale (MARS)

Time Frame: up to 8 months

number of participants with non-adherence to medication assessed by scores of less than 25 points indicating non-adherence

Secondary Outcomes

  • Beliefs about medicines (BMQ)(up to 8 months)
  • Dialysis symptom index(up to 8 months)

Study Sites (1)

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