Behavioral Management of Phosphorus in Hemodialysis Patients

Summary

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.

Conditions

• Cardiovascular Disease (CKD)
• Hyperphosphatemia

Interventions

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.

Sponsors & Collaborators

• NYU Langone Health

  lead OTHER

Principal Investigators

• Mary Sevick, MD · New York University Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-23

Primary Completion

2018-05-01

Completion

2018-05-01

Countries

• United States

Study Locations