Chronic Kidney DiseaseNCT01509027
Study of the Compliance With Phosphorus Restricted Diet and Phosphate Binder Therapy in Hemodialysis Patients
A study testing education by DVD and Education by DVD and dietician in people with Chronic Kidney Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Hyperphosphatemia is a common and severe complication in chronic kidney disease patients treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the cornerstones in the prevention and treatment of this complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- education by DVD and Education by DVD and dietician
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Jun 2012
- Phase
- Interventional
- 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
Who may be able to join
- prevalent (>3months) hemodialysis patients
- aged > 18 years
- informed consent
Who cannot join
- decreased consciousness
- unstable
- medical contraindication for phosphorus restricted diet or phsophate binder therapy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Pieter Evenepoel
Fabienne Dobbels
About this study
Official title: A Randomized Controlled Trial to Evaluate the Impact of Education on the Knowledge About and Compliance With a Phosphorus Restricted Diet and Phosphate Binder Therapy in Maintenance Dialysis Patients
Hyperphosphatemia is a common and severe complication in chronic kidney disease patients treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the cornerstones in the prevention and treatment of this complication. However, noncompliance is an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial proportion of hemodialysis patients. The present study aims at identifying risk factors for non compliance and also test the hypothesis that compliance can be improved by education patients on the consequences of hyperphosphatemia and the importance of diet and phosphate binder therapy.
- Conditions
- Chronic Kidney Disease
- Being tested
- education by DVD, Standard care, Education by DVD and dietician
- Keywords
- hemodialysis, hyperphoshatemia, compliance
- Medical subject headings
- Renal Insufficiency, Chronic, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education by DVDBehavioural
Information on detrimental conseqences of hyperphosphatemia is presented on DVD
Standard careBehavioural
standard care
Education by DVD and dieticianBehavioural
Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican
| Study group | Role | What they receive |
|---|---|---|
| Education by DVD and dietician | Active comparator | Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican Receives: Behavioral: Education by DVD and dietician |
| Education by unpersonalised DVD | Active comparator | Information on detrimental consequences of hyperphosphatemia is presented on DVD Receives: Behavioral: education by DVD |
| Standard Care | Placebo comparator | standard care Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance
impact of education (by DVD and interview with dietician)on compliance with phosphorus restricted diet and phosphate binder therapy
Measured: baseline and after intervention
serum phosphate levels
impact of education (by DVD and interview with dietician) on serum phosphate levels
Measured: baseline and after intervention
Secondary outcomes (1)
risk factors of noncompliance
identification of risk factors for non compliance with emphasis on cognitive function and depression
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509027
- Sponsor's protocol ID
- B322201112895
- Status last verified
- Jan 2012
- First submitted
- 9 Jan 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Impact of Education on the Knowledge About and Compliance With a Phosphorus Restricted Diet and Phosphate Binder Therapy in Maintenance Dialysis Patients
- ClinicalTrials.gov ID
- NCT01509027
- Acronym / sponsor ID
- B322201112895
- Conditions
- Chronic Kidney Disease
- Keywords
- hemodialysis, hyperphoshatemia, compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 12 Jan 2012 (estimated)
- 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.
Hyperphosphatemia is a common and severe complication in chronic kidney disease patients treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the cornerstones in the prevention and treatment of this complication. However, noncompliance is an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial proportion of hemodialysis patients. The present study aims at identifying risk factors for non compliance and also test the hypothesis that compliance can be improved by education patients on the consequences of hyperphosphatemia and the importance of diet and phosphate binder therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education by DVD and dietician | Active comparator | Behavioral: Education by DVD and dieticianInformation on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican |
| Education by unpersonalised DVD | Active comparator | Behavioral: education by DVDInformation on detrimental consequences of hyperphosphatemia is presented on DVD |
| Standard Care | Placebo comparator | Behavioral: Standard carestandard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prevalent (>3months) hemodialysis patients
- aged > 18 years
- informed consent
Key exclusion criteria (3 listed)
- decreased consciousness
- unstable
- medical contraindication for phosphorus restricted diet or phsophate binder therapy
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 |
|---|---|---|
| education by DVDInformation on detrimental conseqences of hyperphosphatemia is presented on DVD | Behavioural | Education by unpersonalised DVD |
| Standard carestandard care | Behavioural | Standard Care |
| Education by DVD and dieticianInformation on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican | Behavioural | Education by DVD and dietician |
Primary outcome
compliance
Time frame: baseline and after intervention
impact of education (by DVD and interview with dietician)on compliance with phosphorus restricted diet and phosphate binder therapy
serum phosphate levels
Time frame: baseline and after intervention
impact of education (by DVD and interview with dietician) on serum phosphate levels
1 secondary outcome
risk factors of noncompliance
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education by DVD and Education by DVD and dietician in people with Chronic Kidney Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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: status not confirmed, as of the sponsor's last update on 30 May 2012. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pieter Evenepoel, MD (003216344580, pieter.evenepoel@uz.kuleuven.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance (time frame: baseline and after intervention). 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?
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 30 May 2012.