Educational Programme Impact on Serum Phosphate Control | NCT02626676

Studies
Educational Programme Impact on Serum Phosphate Control

NCT02626676

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Feb 20, 2017Actual

Enrollment

180Actual

Phase

Not Applicable

Conditions

Renal Insufficiency, Chronic

Interventions

Educational Programme

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Dec 6, 2015

First Submission Date that Met QC Criteria

Dec 8, 2015

First Posted Date

Dec 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2017

Last Update Posted Date

Feb 20, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcus Vinicius de Souza Joao Luiz, MSC., Pharm.D., University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Educational Programme	Other	Educational Programme consists of lectures and group dynamics about nutrition during hemodialysis sessions.	Educational Programme Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcus Vinicius SJ LUIZ, MSc, PharmD	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RenalClass, Dialysis Centre		São Paulo	São Paulo	01239-040	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D054559	Hyperphosphatemia

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

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Browse Branches

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