Clinical Trial: Behavioral Management of Phosphorus in Hemodialysis Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Behavioral Management of Phosphorus in Hemodialysis

Brief 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.

Detailed Summary: 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.
Sponsor: New York University School of Medicine

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 8-item Morisky Medication Adherence Survey (MMAS-8) [ Time Frame: 24 Weeks ]
    Used to measure Binder Adherence, has been shown to be a valid and reliable measure of antihypertensive medication adherence
  • Reported dietary energy, protein and phosphorus intake [ Time Frame: 2 Weeks ]
    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.
  • Normalized protein catabolic rate (nPCR) [ Time Frame: 24 Weeks ]
    The nPCR is an objective measure of protein intake in HD patients based on the accumulation of urea nitrogen in blood between dialysis treatments
  • Serum phosphorus. [ Time Frame: 24 Weeks ]
    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.
  • Frequency and severity of participant symptoms assessed via an investigator-developed questionnaire [ Time Frame: 24 Weeks ]
    (itching, bone and joint pain, cramping) and phosphorus binders (difficulty defecating, loose or watery stools) will be self-reported via an investigator-developed questionnaire.
  • Balance Wise Self-Efficacy for Restricting Dietary Sodium in Hemodialysis Scale [ Time Frame: 24 Weeks ]
    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.


Original Secondary Outcome: Same as current

Information By: New York University School of Medicine

Dates:
Date Received: October 17, 2016
Date Started: April 27, 2017
Date Completion: April 2018
Last Updated: April 27, 2017
Last Verified: April 2017