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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
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 6, 2015
Last Updated
February 17, 2017
Sponsor
University of Sao Paulo
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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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