Behavioral Management of Phosphorus in Hemodialysis Patients

Behavioral Management of Phosphorus in Hemodialysis

The purpose of this randomized clinical trial is to evaluate alternative technology-supported behavioral approaches to engaging 42 maintenance hemodialysis (HD) patients with persistent hyperphosphatemia in phosphorus binder adherence and dietary phosphorus restriction. Participants will be randomized to 1 of 3 intervention groups: (1) Education (Edu); (2) Edu + Self-Monitoring (SM); or (3) Edu + SM + Social Cognitive Theory (SCT)-based training program.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia; Cardiovascular Disease (CKD)
• Intervention / Treatment: Behavioral: Education (Edu); Behavioral: SM intervention; Behavioral: Social Cognitive Therapy (SCT)

Detailed Description

Investigators will evaluate the intervention in terms of feasibility and acceptability, behavior change at 12 and 24 weeks (reported phosphorus binder adherence, reported nutrient intakes, normalized protein catabolic rate), and clinical outcomes (serum phosphorus concentrations, symptoms). In addition, the impact of the different behavioral approaches on self-efficacy at 12 and 24 weeks, and the mediating effects of self-efficacy in facilitating behavioral changes and clinical outcomes will be examined.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Receiving thrice-weekly hemodialysis treatment for at least 3 months
• 3-month average serum phosphorus concentration >5.5 mg/dL

Exclusion Criteria:

• Unable to participate meaningfully in the combined Edu + SM + SCT intervention, including:
• Unable to read and/or speak English
• Self-monitoring application is currently available in English only (patients will not be excluded from participation on the basis of race/ethnicity)
• Cognitively-impaired
• Physically-impaired
• Institutionalized or otherwise having limited control over diet
• Life expectancy of <1 year per dialysis center staff
• Women who are pregnant or become pregnant during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Education (Edu)	Behavioral: Education (Edu); This intervention will take place during weeks 1-4 at the dialysis center. Each week, study staff will present participants with a brief educational video on: phosphorus binder adherence (week 1), meeting dietary protein needs (week 2), restricting dietary sources of phosphorus (week 3), and eliminating phosphorus-based food additives (week 4). These videos will be loaded onto tablet (Personal Computers) PCs so that participants can easily view them during regular dialysis treatment.
Active Comparator: Edu + Self-Monitoring (SM)	Behavioral: Education (Edu); This intervention will take place during weeks 1-4 at the dialysis center. Each week, study staff will present participants with a brief educational video on: phosphorus binder adherence (week 1), meeting dietary protein needs (week 2), restricting dietary sources of phosphorus (week 3), and eliminating phosphorus-based food additives (week 4). These videos will be loaded onto tablet (Personal Computers) PCs so that participants can easily view them during regular dialysis treatment.; Behavioral: SM intervention; During the first 12 weeks of the intervention, a study dietitian will review the participants' records, and provide individualized feedback via a password-protected NYULMC email address. Feedback will be provided twice per week during weeks 1-4, once per week during weeks 5-8, and once every two weeks during weeks 9-12. The email messages will focus on both the importance of self-monitoring and the behavioral targets of the intervention. Feedback will use standardized language rather than specific dietary examples to avoid providing individualized counseling to participants (which is not the purpose of the SM intervention).
Active Comparator: Edu + SM + Social Cognitive Theory (SCT)	Behavioral: Education (Edu); This intervention will take place during weeks 1-4 at the dialysis center. Each week, study staff will present participants with a brief educational video on: phosphorus binder adherence (week 1), meeting dietary protein needs (week 2), restricting dietary sources of phosphorus (week 3), and eliminating phosphorus-based food additives (week 4). These videos will be loaded onto tablet (Personal Computers) PCs so that participants can easily view them during regular dialysis treatment.; Behavioral: SM intervention; During the first 12 weeks of the intervention, a study dietitian will review the participants' records, and provide individualized feedback via a password-protected NYULMC email address. Feedback will be provided twice per week during weeks 1-4, once per week during weeks 5-8, and once every two weeks during weeks 9-12. The email messages will focus on both the importance of self-monitoring and the behavioral targets of the intervention. Feedback will use standardized language rather than specific dietary examples to avoid providing individualized counseling to participants (which is not the purpose of the SM intervention).; Behavioral: Social Cognitive Therapy (SCT); This intervention will be delivered remotely online using the same tablet PCs provided for the SM intervention component of this treatment condition. The behavioral training program will focus on building a sense of self-efficacy with emphasis on mastery experiences that will include emphasizing past successes; setting incremental, easily achievable goals; self-monitoring to stay on track; identifying modifiable barriers to healthy behavior; positive feedback in goal achievement; and developing participant expertise in both the regimen and in problem solving around barriers to adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Hemodialysis (HD) patients that are eligible for the study	Measure of feasibility	24 Weeks
Proportion of eligible patients who agree to participate	Measure of feasibility	24 Weeks
Proportion of enrolled participants who complete the study	Measure of Acceptability	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
8-item Morisky Medication Adherence Survey (MMAS-8)	Used to measure Binder Adherence, has been shown to be a valid and reliable measure of antihypertensive medication adherence	24 Weeks
Reported dietary energy, protein and phosphorus intake	participants will be directed to complete three, non-consecutive food records over the two-week period. Diet record days will include two weekdays (1 dialysis day and 1 non-dialysis day), and one non-dialysis weekend day.	2 Weeks
Normalized protein catabolic rate (nPCR)	The nPCR is an objective measure of protein intake in HD patients based on the accumulation of urea nitrogen in blood between dialysis treatments	24 Weeks
Serum phosphorus.	Pre-dialysis serum phosphorus concentrations are a key secondary clinical endpoint for this intervention. Serum phosphorus is already being measured in participants as part of the routine monthly laboratory blood work, so this information will be obtained from the participant's medical charts.	24 Weeks
Frequency and severity of participant symptoms assessed via an investigator-developed questionnaire	(itching, bone and joint pain, cramping) and phosphorus binders (difficulty defecating, loose or watery stools) will be self-reported via an investigator-developed questionnaire.	24 Weeks
Balance Wise Self-Efficacy for Restricting Dietary Sodium in Hemodialysis Scale	be adapted to focus on adherence to phosphorus binders, dietary phosphorus restrictions and adequacy of protein intake. The self-efficacy questionnaire asks participants' to report their confidence in the next month that they will be able to complete various tasked related to the study intervention. An overall scale, and subscale scores for phosphorus binders, dietary phosphorus restriction and adequacy of protein intake will be computed by summing pertinent items for analyses.	24 Weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Mary Sevick, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Hemodialysis
• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Cardiovascular Diseases; Hyperphosphatemia
• Other Study ID Numbers: 16-00817

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No