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Completed

NCT Number: NCT02940743

Behavioral Management of Phosphorus in Hemodialysis Patients

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.

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Key information

Conditions

Cardiovascular Disease (CKD) Cardiovascular Diseases Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

19 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education (Edu)

Behavioral

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.

SM intervention

Behavioral

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).

Social Cognitive Therapy (SCT)

Behavioral

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.

Primary outcomes

  1. Proportion of Hemodialysis (HD) patients that are eligible for the study

    Time frame: 24 Weeks

    Measure of feasibility

  2. Proportion of eligible patients who agree to participate

    Time frame: 24 Weeks

    Measure of feasibility

  3. Proportion of enrolled participants who complete the study

    Time frame: 24 Weeks

    Measure of Acceptability

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Behavioral Management of Phosphorus in Hemodialysis

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 21, 2016
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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