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

NCT03897231 | Completed

• 1 other identifier: NNF17OC0029778
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence; End Stage Renal Failure on Dialysis

Outcome Measures

Primary Outcomes (2)

• the Morisky-Green-Levine scale (MAQ)

  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)

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

  up to 8 months

Secondary Outcomes (2)

• Beliefs about medicines (BMQ)

  up to 8 months

• Dialysis symptom index

  up to 8 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• cognitive impairment
• no current medication prescriptions

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Herlev Hospital: collaborator
• Hillerod Hospital, Denmark: collaborator

Study Sites (1)

Department of Nephology

Copenhagen, Denmark

Location

Related Publications (1)

• Mechta Nielsen T, Marott T, Hornum M, Feldt-Rasmussen B, Kallemose T, Thomsen T. Non-adherence, medication beliefs and symptom burden among patients receiving hemodialysis -a cross-sectional study. BMC Nephrol. 2023 Oct 27;24(1):321. doi: 10.1186/s12882-023-03371-3.

  PMID: 37891566 DERIVED

MeSH Terms

Conditions

Medication Adherence

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Bo Feldt-rasmussen, Professor

  Department of Nephrology, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 1, 2019
• Study Start: May 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

DK (1)