Development of a 'Phosphate Counting Program'

NCT01643486 | Unknown

• 1 other identifier: iTouch Phase 3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

End Stage Renal Disease

Keywords

peritoneal dialysis; phosphate; iTouch

Outcome Measures

Primary Outcomes (1)

• Serum Phosphate

  The primary end point of the study will be a comparison of the serum phosphate between the two study groups at the end of the 3 months. An unpaired t-test will be used with a value of \<0.05 considered to be statistically significant in an intent to treat analysis.

  3 months

Study Arms (2)

iTouch phosphate counting program

EXPERIMENTAL

All patients will have an iTouch that will help them to calculate the required number of phosphate binders to be taken with each meal

Other: iTouch phosphate counting program

Usual Care

ACTIVE COMPARATOR

Participants in the active comparator group will document their meals in the iTouch but continue to take their phosphate binders as prescribed by their MD/dietician

Other: Usual Care

Interventions

iTouch phosphate counting program OTHER

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

iTouch phosphate counting program

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End stage renal disease treated with peritoneal dialysis
• On calcium carbonate phosphate binder therapy
• English or French speaking/writing

You may not qualify if:

• Cognitive dysfunction that might interfere with ability to participate
• Unable or unwilling to give informed consent
• Hypercalcemia
• Visually impaired
• Hearing impaired
• Expected renal transplant during the time of the study

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Baxter Healthcare Corporation: collaborator
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

Related Publications (1)

• Farfan-Ruiz AC, Czikk D, Leidecker J, Ramsay T, McCormick B, Wilson K, Zimmerman D. Multidisciplinary Team versus a "Phosphate-Counting" App for Serum Phosphate Control: A Randomized Controlled Trial. Kidney360. 2020 Dec 15;2(2):290-297. doi: 10.34067/KID.0007132020. eCollection 2021 Feb 25.

  PMID: 35373021 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Deborah Zimmerman, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: February 1, 2021
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

CA (1)