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

April 15, 2021 updated by: Bo Feldt-Rasmussen, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Department of Nephology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with end stage kidney disease receiving hemodialysis treatment ≥3 month at a hospital-based outpatient hemodialysis Centre in the Capital region of Denmark

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 8 months
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
up to 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beliefs about medicines (BMQ)
Time Frame: 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
up to 8 months
Dialysis symptom index
Time Frame: up to 8 months
the overall symptom burden assessed by the total number of symptoms reported by each participant.
up to 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Herlev Hospital
Hillerod Hospital, Denmark

Investigators

  • Principal Investigator: Bo Feldt-rasmussen, Professor, Department of Nephrology, Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 15, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NNF17OC0029778

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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