Medication AdherenceNCT03897231
Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis
An observational study of Medication Adherence and End Stage Renal Failure on Dialysis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, End Stage Renal Failure on Dialysis
- What is being tested?
- questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 385 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2019to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- cognitive impairment
- no current medication prescriptions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis - a Multicenter Cross-sectional Study
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.
Read more
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.
- Being tested
- questionnaire
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
the Morisky-Green-Levine scale (MAQ)
number of participants with non-adherence to medication assessed by scores of ≥1 indicating non-adherence
Measured: 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
Measured: up to 8 months
Secondary outcomes (2)
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
Measured: up to 8 months
Dialysis symptom index
the overall symptom burden assessed by the total number of symptoms reported by each participant.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 May 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Hillerod Hospital, Denmark
- Responsible party
- Principal investigator, Bo Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bo Feldt-rasmussen, Professor, Principal investigator, Department of Nephrology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897231
- Sponsor's protocol ID
- NNF17OC0029778
- Status last verified
- Apr 2021
- First submitted
- 27 Mar 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37891566
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis - a Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03897231
- Acronym / sponsor ID
- NNF17OC0029778
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Herlev Hospital, Hillerod Hospital, Denmark
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- cognitive impairment
- no current medication prescriptions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireParticipants 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. | Other | – |
Primary outcome
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
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
2 secondary outcomes
Beliefs about medicines (BMQ)
Time frame: up to 8 months
Dialysis symptom index
Time frame: up to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 37891566Mechta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Feldt-rasmussen, Professor principal investigator
Department of Nephrology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Adherence and End Stage Renal Failure on Dialysis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Morisky-Green-Levine scale (MAQ) (time frame: up to 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03897231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.