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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00296439
Other study ID # 0034
Secondary ID
Status Recruiting
Phase N/A
First received February 23, 2006
Last updated February 23, 2006
Start date February 2006
Est. completion date February 2006

Study information

Verified date February 2006
Source Edward Hines Jr. VA Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Hemodialysis patients who receive frequent weekly nutrition counseling using motivational interviewing techniques will have lower serum phosphorus levels compared to patients receiving standard treatment.


Description:

Hemodialysis patients will receive weekly nutrition counseling on how to lower their serum Phosphorus levels. Motivational interviewing techniques and strategies will be employed such as reflective listening, using affirmations, and summarizing. Average serum Phosphorus levels pre-dialysis will be compared to s.Ph post counseling. This will be compared to a group receiving nutrition counseling via standard treatment on a monthly basis.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 85 Years
Eligibility Inclusion Criteria:

- ESRD patients on dialysis with serum Ph > 5.5 mg/dL four of six labs over 6 months, mentally competent

Exclusion Criteria:

- ESRD patients on dialysis with serum Ph < 5.5 mg/dL four of six labs over 6 months, mentally incompetent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavior


Locations

Country Name City State
United States Edward Hines,Jr., VA Hospital Hines Illinois
United States Hines VA Hospital Hines Illinois

Sponsors (1)

Lead Sponsor Collaborator
Edward Hines Jr. VA Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum Phosphorus levels
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