Renal Insufficiency, ChronicEPICNCT02626676
Educational Programme Impact on Serum Phosphate Control
A study testing Educational Programme in people with Renal Insufficiency, Chronic, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Educational Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Mar 2016
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who freely consent to participate in this study
- aged from 18 years or older
- both genders
- phosphate serum levels higher than 5.5 mg/dl (last 3 consecutive monthly measures)
Who cannot join
- patients who do not consent to participate in this study
- pregnant
- cognitive deficit
- mental diseases
- patients whose phosphate serum levels lower than 5.5 mg/dl or equal to 5.5 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrition Educational Programme Impact on Serum Phosphate Control
Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Objectives: The aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods: A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D Chronic Kidney Disease patients who exhibit phosphate serum levels > 5.5 mg/dL. The educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. Anthropometric, clinical, demographic and laboratory parameters (serum phosphorus concentration will be evaluated and the transtheoretical model of eating behavior (TMFB) will be applied pre- and post-intervention.
Read the detailed description
Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Objectives: The aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods: A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D Chronic Kidney Disease patients who exhibit phosphate serum levels > 5.5 mg/dL. The educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. Anthropometric (weight, height, body mass index), clinical, demographic (sex, age, time on dialysis programme, literacy/schooling) and laboratory parameters (phosphate serum levels) will be evaluated and the transtheoretical model of eating behavior (TMFB) will be applied pre- and post-intervention. Reduction of phosphate serum levels and positive/negative behavioral changes will be the evaluated outcomes. Statistical Analyses will be carried out in order to compare the effect of educational programme on phosphate serum levels and on the behaviour changes.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Educational Programme
- Keywords
- renal dialysis, hyperphosphatemia, educational programme
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ProgrammeOther
Educational Programme consists of lectures and group dynamics about nutrition during hemodialysis sessions.
| Study group | Role | What they receive |
|---|---|---|
| Educational Programme Group | Experimental | Stage 5D Chronic Kidney Disease Patients on high-efficiency hemodialysis programme - 4-hour sessions, 3 times a week will be followed up Receives: Other: Educational Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of PhosphateSerum Level
Phosphate Serum Levels above or equal 5.5 mg/dl will be monitored in order to identify reduction
Measured: 3 months
Secondary outcomes (1)
Positive or Negative Behavioral Change According to the Transtheoretical Model of Eating Behavior
After intervention (3 months), it will be identified whether patients show Positive or Negative Behavioral change (according to the transtheoretical model of eating behavior) will be identified
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Vinicius de Souza Joao Luiz, University of Sao Paulo
- Investigators
- Marcus Vinicius SJ LUIZ, MSc, PharmD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626676
- Sponsor's protocol ID
- USAoPaulo EPIC
- Acronym
- EPIC
- Status last verified
- Feb 2017
- First submitted
- 6 Dec 2015
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Educational Programme Impact on Serum Phosphate Control
- ClinicalTrials.gov ID
- NCT02626676
- Acronym / sponsor ID
- EPIC / USAoPaulo EPIC
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- renal dialysis, hyperphosphatemia, educational programme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Dec 2015 (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.
Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Objectives: The aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods: A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D Chronic Kidney Disease patients who exhibit phosphate serum levels > 5.5 mg/dL. The educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. Anthropometric, clinical, demographic and laboratory parameters (serum phosphorus concentration will be evaluated and the transtheoretical model of eating behavior (TMFB) will be applied pre- and post-intervention.
Detailed description
Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Objectives: The aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods: A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D Chronic Kidney Disease patients who exhibit phosphate serum levels > 5.5 mg/dL. The educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. Anthropometric (weight, height, body mass index), clinical, demographic (sex, age, time on dialysis programme, literacy/schooling) and laboratory parameters (phosphate serum levels) will be evaluated and the transtheoretical model of eating behavior (TMFB) will be applied pre- and post-intervention. Reduction of phosphate serum levels and positive/negative behavioral changes will be the evaluated outcomes. Statistical Analyses will be carried out in order to compare the effect of educational programme on phosphate serum levels and on the behaviour changes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Programme Group | Experimental | Other: Educational ProgrammeStage 5D Chronic Kidney Disease Patients on high-efficiency hemodialysis programme - 4-hour sessions, 3 times a week will be followed up |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who freely consent to participate in this study
- aged from 18 years or older
- both genders
- phosphate serum levels higher than 5.5 mg/dl (last 3 consecutive monthly measures)
Key exclusion criteria (5 listed)
- patients who do not consent to participate in this study
- pregnant
- cognitive deficit
- mental diseases
- patients whose phosphate serum levels lower than 5.5 mg/dl or equal to 5.5 mg/dl
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 |
|---|---|---|
| Educational ProgrammeEducational Programme consists of lectures and group dynamics about nutrition during hemodialysis sessions. | Other | Educational Programme Group |
Primary outcome
Reduction of PhosphateSerum Level
Time frame: 3 months
Phosphate Serum Levels above or equal 5.5 mg/dl will be monitored in order to identify reduction
1 secondary outcome
Positive or Negative Behavioral Change According to the Transtheoretical Model of Eating Behavior
Time frame: 3 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 20 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Marcus Vinicius SJ LUIZ, MSc, PharmD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Programme in people with Renal Insufficiency, Chronic, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 5 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 20 Feb 2017. 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 Brazil. 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?
Reduction of PhosphateSerum Level (time frame: 3 months). 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 20 Feb 2017.