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Trial record 96 of 141 for:    MPL

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

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ClinicalTrials.gov Identifier: NCT03897231
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborators:
Novo Nordisk A/S
Herlev Hospital
Hillerod Hospital, Denmark
Information provided by (Responsible Party):
Bo Feldt-Rasmussen, Rigshospitalet, Denmark

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 April 2019 - December 2020. 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
Medication Adherence End Stage Renal Failure on Dialysis Other: questionnaire

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Study Type : Observational
Estimated Enrollment : 405 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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis


Intervention Details:
  • 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), Copenhagen University Hospital, Hillerød (MPL) and Copenhagen University Hospital Herlev (CPB) 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 Outcome Measures :
  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 Outcome Measures :
  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.

  3. Dialysis symptom index [ Time Frame: up to 8 months ]
    the overall symptom severity score assessed by scores ranging from 0-150 using a five-point Likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897231


Contacts
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Contact: Trine Mechta Nielsen, Phd Student 0045 35458251 trine.mechta.nielsen@regionh.dk
Contact: Thordis Thomsen, Assprofessor thordis.thomsen@regionh.dk

Sponsors and Collaborators
Rigshospitalet, Denmark
Novo Nordisk A/S
Herlev Hospital
Hillerod Hospital, Denmark
Investigators
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Principal Investigator: Bo Feldt-rasmussen, Professor Department of Nephrology, Rigshospitalet

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Responsible Party: Bo Feldt-Rasmussen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03897231     History of Changes
Other Study ID Numbers: NNF17OC0029778
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic