Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis

Completed

• Conditions: Medication Adherence; End Stage Renal Failure on Dialysis

• Registration Number: NCT03897231
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-01
• Study Start: 2019-05-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-15
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medication adherence report scale (MARS)	up to 8 months	number of participants with non-adherence to medication assessed by scores of less than 25 points indicating non-adherence
the Morisky-Green-Levine scale (MAQ)	up to 8 months	number of participants with non-adherence to medication assessed by scores of ≥1 indicating non-adherence

Secondary Outcome Measures

Name	Time	Method
Beliefs about medicines (BMQ)	up to 8 months	number of participants that believe the necessity of their medication outweighs the cost of taking it assessed by scores ranging fra - 20 to + 20, with a postivie number indicating that patients belief in the benefit of mediciations overweights concerns about taking them
Dialysis symptom index	up to 8 months	the overall symptom burden assessed by the total number of symptoms reported by each participant.

Trial Locations

Locations (1)

Department of Nephology; 🇩🇰 Copenhagen, Denmark