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Completed

NCT Number: NCT03897231

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

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.

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Key information

Conditions

Medication Adherence Behavior End Stage Renal Failure on Dialysis Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nephology

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Questionnaire

Other

Participants will be invited to participate in the study during their dialysis treatment at the participating hemodialysis outpatient centres. Allocated nurses at Copenhagen University Hospital, Rigshospitalet (MS, AB, LFH, AH), Copenhagen University Hospital, Hillerød (MPL) and Copenhagen University Hospital Herlev (TM) will be responsible for recruitment. Eligible patients will be informed orally and in writing about the study. Participants who wish to participate will be asked to provide informed consent and, following this, complete a paper-based questionnaire during treatment. Patients who have difficulty reading Danish and patients with visual or physical impairments that impinge on their ability to complete the questionnaires will be interviewed using a structured interview approach based on the questionnaires.

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. Dialysis symptom index

    Time frame: up to 8 months

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Herlev Hospital
  • Hillerod Hospital, Denmark

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2019
Registry last updated
Apr 19, 2021

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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