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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897231
• Other study ID #: NNF17OC0029778
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic
• Medication Adherence

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Department of Nephology	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Herlev Hospital, Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Beliefs about medicines (BMQ)	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
Secondary	Dialysis symptom index	the overall symptom burden assessed by the total number of symptoms reported by each participant.	up to 8 months