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

NCT ID: NCT03897231

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medication Adherence End Stage Renal Failure on Dialysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaire

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Herlev Hospital

OTHER

Sponsor Role collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bo Feldt-Rasmussen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bo Feldt-rasmussen, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Rigshospitalet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Nephology

Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37891566 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NNF17OC0029778

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preventing Early Dialysis Starts
NCT02183987 COMPLETED NA
Symptom Management in Patients on Dialysis
NCT05515991 ACTIVE_NOT_RECRUITING NA
Shared Decision Making in Dialysis
NCT04392440 COMPLETED NA