Development of a 'Phosphate Counting Program'

NCT ID: NCT01643486

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2021-02-28

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

Detailed Description

Project approach and work plan:

Phase 1: In the week prior to the collection of standard pre-clinic blood work (to include calcium, phosphate, PTH), PD patients will keep a 3-day diary that will include all foods and beverages consumed in addition to the portion sizes. At the time of standard pre-clinic bloodwork collection, patients will perform an adequest. Medication lists will be reviewed for: 1) Proton pump inhibitors/ H2 receptor antagonists 2) 25-hydroxyvitamin D3 and 1,25 dihydroxyvitamin D3 and 3) phosphate binders. Doses taken the week prior to standard pre-clinic blood work when the diet diaries are compiled will be recorded. This information will be used for 2 separate purposes: 1) A list of the foods that are actually being eaten by the PD patients will be generated 2) The 3-day average phosphate content will be estimated from each PD patient's food diaries. A regression equation that predicts serum phosphate concentration taking into account phosphate intake, the amount of phosphate binders taken, the dose of vitamin D, use of proton pump inhibitors/H2 antagonists, dialysis adequacy, and serum PTH concentration will be generated.

Phase 2: An iTouch program will be developed using Phase 1 information to assist patients in meal phosphate counting and appropriate binder selection. Processes used to develop similar programs such as the pilot study in patients with diabetes mellitus will be used. A convenience sample of 10 PD patients will use the iTouch program for one month and document their impressions about ease of use, convenience and applicability to their diet choices. Changes to the program will be incorporated based on the patient's comments and laboratory values. If substantial changes are required, another convenience sample of 10 PD patients will be invited to use the program and provide feedback.

Phase 3: 80 consenting PD patients from the Ottawa Hospital and St. Michael's Hospital (if required) will be randomized to usual care for managing phosphate versus use of the iTouch program for meal phosphate counting and matching binder use. This phase of the trial will last 3 months. As simply recording meal phosphate intake in the iTouch program may have an impact on patient behavior, the control group will be asked to enter this data into the program but no binder therapy information will be provided to the patients. During the course of the study, the dose of vitamin D and PD prescription will be held constant in both groups.

Expected Outcome:

Phase 1: All 60 PD patients will be recruited over a 6-month period. Data entry and statistical analysis are expected to take another 2-4 months. Phase 2: Actual development of the iTouch program using the data generated in phase 1 is expected to take about 6 months. It is anticipated that all 10 patients will be recruited over a 2-month period with a further one-month of follow-up. Interviews with the patients and collation of the data are expected to take another month. It is unclear how much time will be required to make adjustments to the iTouch program but we anticipate <3months.

Phase 3: We anticipate that we can recruit the 80 patients from the greater than 250 patients at the Ottawa Hospital and St Michaels Home Dialysis programs and complete the 3 months of follow-up in approximately 12-18months. Data analysis and manuscript preparation should take another 4-5 months.

Feasibility Given the large number of PD patients in the two programs, the novelty of Phase 2 and 3 and the incentives in Phase 3, we do not anticipate difficulties with recruitment. The laboratory tests are all standard and visits will occur during a patient's regularly scheduled PD visit.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

iTouch phosphate counting program

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

Group Type: EXPERIMENTAL

iTouch phosphate counting program

Intervention Type: 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

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. End stage renal disease treated with peritoneal dialysis

2. On calcium carbonate phosphate binder therapy

3. English or French speaking/writing

Exclusion Criteria

1. Cognitive dysfunction that might interfere with ability to participate

2. Unable or unwilling to give informed consent

3. Hypercalcemia

4. Visually impaired

5. Hearing impaired

6. Expected renal transplant during the time of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

The Ottawa Hospital Academic Medical Association

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah Zimmerman, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35373021 (View on PubMed)

Other Identifiers

iTouch Phase 3

Identifier Type: -

Identifier Source: org_study_id