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Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?

Primary Purpose

End Stage Renal Disease Requiring Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Intensive Tailored Education
Sponsored by
Academy of Nutrition and Dietetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease Requiring Hemodialysis

Eligibility Criteria

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

Inclusion Criteria:

  • Average Interdialytic weight gain (IDWG) for 2 weeks prior to screening period greater than or equal to 4% estimated dry weight
  • Able to sign the locally approved informed consent
  • Willing to receive dietitian education on sodium and fluid control during normal dialysis time
  • Receiving thrice weekly maintenance hemodialysis for greater than or equal to 6 months Age greater than or equal to 18 years

Exclusion Criteria:

  • On hospice or international equivalent
  • Receiving corticosteroid treatment
  • Less than 18 years old
  • On interdialytic parenteral nutrition
  • Transfer to another facility expected within 3 months
  • Severe malnutrition, as assessed by Subjective Global Assessment (SGA) or other standard assessment tool

Sites / Locations

  • Auckland Board of Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All patients

Arm Description

Intensive tailored education

Outcomes

Primary Outcome Measures

Average Percent Interdialytic Weight Gain

Secondary Outcome Measures

Thirst Intensity
will be measured by a 100 mm Visual Analog Scale. Patients are asked to mark the point on the VAS which represents their work thirst since the last dialysis. Zero is considered no thirst and 100 is extremely thirsty. This tool has been shown to correlate to the Thirst Distress tool developed by Welsh in 2002.
Sodium and Fluid Knowledge
Will be assessed using the sodium questions of the tool created by Kim (Korean J Nutr 2001), as modified by Park (J Ren Nutr 2008).

Full Information

First Posted
April 28, 2014
Last Updated
January 26, 2016
Sponsor
Academy of Nutrition and Dietetics
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1. Study Identification

Unique Protocol Identification Number
NCT02130089
Brief Title
Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
Official Title
Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academy of Nutrition and Dietetics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this project is to understand if more frequent education of dialysis patients (patients with kidney failure who get their blood cleaned and fluid removed by a machine instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that patients gain between dialysis sessions. Patients who usually gain more fluid than is considered ideal will be recruited for this project. Because all patients gain different amounts to start, data will be collected for 3 months while the patients receive their usual amount of dietitian education. Then the patients will receive intensive (2x/month) education on reducing sodium intake from the dietitian and the same data will be collected to see if they gain less after the education. After 3 months of intensive education, data will be collected for one more month to see if patients keep gaining less or if they go back to their old patterns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease Requiring Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Other
Arm Description
Intensive tailored education
Intervention Type
Behavioral
Intervention Name(s)
Intensive Tailored Education
Primary Outcome Measure Information:
Title
Average Percent Interdialytic Weight Gain
Time Frame
monthly for 7 months
Secondary Outcome Measure Information:
Title
Thirst Intensity
Description
will be measured by a 100 mm Visual Analog Scale. Patients are asked to mark the point on the VAS which represents their work thirst since the last dialysis. Zero is considered no thirst and 100 is extremely thirsty. This tool has been shown to correlate to the Thirst Distress tool developed by Welsh in 2002.
Time Frame
monthly for 7 months
Title
Sodium and Fluid Knowledge
Description
Will be assessed using the sodium questions of the tool created by Kim (Korean J Nutr 2001), as modified by Park (J Ren Nutr 2008).
Time Frame
Monthly for 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Average Interdialytic weight gain (IDWG) for 2 weeks prior to screening period greater than or equal to 4% estimated dry weight Able to sign the locally approved informed consent Willing to receive dietitian education on sodium and fluid control during normal dialysis time Receiving thrice weekly maintenance hemodialysis for greater than or equal to 6 months Age greater than or equal to 18 years Exclusion Criteria: On hospice or international equivalent Receiving corticosteroid treatment Less than 18 years old On interdialytic parenteral nutrition Transfer to another facility expected within 3 months Severe malnutrition, as assessed by Subjective Global Assessment (SGA) or other standard assessment tool
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra McLellan
Organizational Affiliation
Auckland Board of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auckland Board of Health
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?

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