Educational Programme Impact on Serum Phosphate Control

NCT02626676 | Completed DMC

• 1 other identifier: USAoPaulo EPIC
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic

Keywords

renal dialysis, hyperphosphatemia, educational programme

Outcome Measures

Primary Outcomes (1)

• Reduction of PhosphateSerum Level

  Phosphate Serum Levels above or equal 5.5 mg/dl will be monitored in order to identify reduction

  3 months

Secondary Outcomes (1)

• Positive or Negative Behavioral Change According to the Transtheoretical Model of Eating Behavior

  3 months

Study Arms (1)

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

Other: Educational Programme

Interventions

Educational Programme OTHER

Educational Programme consists of lectures and group dynamics about nutrition during hemodialysis sessions.

Educational Programme Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

RenalClass, Dialysis Centre

São Paulo, São Paulo, 01239-040, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marcus Vinicius SJ LUIZ, MSc, PharmD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSC., Pharm.D.

Study Record Dates

• First Submitted: December 6, 2015
• First Posted: December 10, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)