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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03897231
Collaborator
Herlev Hospital (Other), Hillerod Hospital, Denmark (Other)
385
1
20.1
19.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire

Study Design

Study Type:
Observational
Actual Enrollment :
385 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis - a Multicenter Cross-sectional Study
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Secondary Outcome Measures

  1. 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

  2. Dialysis symptom index [up to 8 months]

    the overall symptom burden assessed by the total number of symptoms reported by each participant.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nephology Copenhagen Denmark

Sponsors and Collaborators

  • Rigshospitalet, Denmark
  • Herlev Hospital
  • Hillerod Hospital, Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bo Feldt-Rasmussen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT03897231
Other Study ID Numbers:
  • NNF17OC0029778
First Posted:
Apr 1, 2019
Last Update Posted:
Apr 19, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2021