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

Study Overview
=================
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.

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

Conditions
-----------------
End Stage Renal Disease Requiring Hemodialysis

Intervention / Treatment
-----------------
* Behavioral: Intensive Tailored Education


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All patients<br>Intensive tailored education | Behavioral: Intensive Tailored Education<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Percent Interdialytic Weight Gain |  | monthly for 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | monthly for 7 months | 
| 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). | Monthly for 4 months |