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Development of a 'Phosphate Counting Program'

NCT01643486 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-07-08

No results posted yet for this study

Summary

Hypothesis: The use of a program that assists with selection of the appropriate number of phosphate binders for a meal based on patient specific factors will result in improved serum phosphate control, a reduction in overall number of phosphate binders used and enhanced patient satisfaction.

Primary Aim: To determine if teaching patients to use a 'phosphate counting' program installed on an iTouch that selects the appropriate amount of phosphate binder to be taken with each meal is associated with better phosphate control than usual care.

Research Plan: There will be 3 phases to the study. Phase 1: Recruitment of 60 peritoneal dialysis (PD) patients. The information generated from this phase will be used to develop the iTouch program for phosphate counting and matching binder number. Phase 2: iTouch program once developed will be pilot tested on a convenience sample of 10 PD patients and modified if required. Phase 3: Randomized controlled trial of 92 PD patients to determine if using the iTouch phosphate counting program reduces serum phosphate compared to controls. Success would be based on seeing a statistically significant difference in serum phosphate as expected from our sample size calculation

Conditions

Interventions

OTHER

iTouch phosphate counting program

After developing and pilot testing the iTouch phosphate counting program, the participants in the intervention arm will enter their meal into the program; the required number of phosphate binders will be calculated for the patient

OTHER

Usual Care

The patients randomized to the usual care arm will continue to receive the usual dietary counselling and will input meal data into the iTouch program but no recommendations for the number of phosphate binders to be taken with the meal will be provided

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • The Ottawa Hospital Academic Medical Association

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Deborah Zimmerman, MD · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-07-31
Completion
2021-02-28

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01643486 on ClinicalTrials.gov