Educational Programme Impact on Serum Phosphate Control (EPIC)
Primary Purpose
Renal Insufficiency, Chronic
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Educational Programme
Sponsored by
About this trial
This is an interventional health services research trial for Renal Insufficiency, Chronic focused on measuring renal dialysis, hyperphosphatemia, educational programme
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- RenalClass, Dialysis Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Educational Programme Group
Arm Description
Stage 5D Chronic Kidney Disease Patients on high-efficiency hemodialysis programme - 4-hour sessions, 3 times a week will be followed up
Outcomes
Primary Outcome Measures
Reduction of PhosphateSerum Level
Phosphate Serum Levels above or equal 5.5 mg/dl will be monitored in order to identify reduction
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02626676
First Posted
December 6, 2015
Last Updated
February 17, 2017
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02626676
Brief Title
Educational Programme Impact on Serum Phosphate Control
Acronym
EPIC
Official Title
Nutrition Educational Programme Impact on Serum Phosphate Control
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
renal dialysis, hyperphosphatemia, educational programme
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational Programme Group
Arm Type
Experimental
Arm Description
Stage 5D Chronic Kidney Disease Patients on high-efficiency hemodialysis programme - 4-hour sessions, 3 times a week will be followed up
Intervention Type
Other
Intervention Name(s)
Educational Programme
Intervention Description
Educational Programme consists of lectures and group dynamics about nutrition during hemodialysis sessions.
Primary Outcome Measure Information:
Title
Reduction of PhosphateSerum Level
Description
Phosphate Serum Levels above or equal 5.5 mg/dl will be monitored in order to identify reduction
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Positive or Negative Behavioral Change According to the Transtheoretical Model of Eating Behavior
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Vinicius SJ LUIZ, MSc, PharmD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
RenalClass, Dialysis Centre
City
Sao Paulo
ZIP/Postal Code
01239-040
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Educational Programme Impact on Serum Phosphate Control
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