Back to resultsBehavioral Management of Phosphorus in Hemodialysis Patients
Primary Purpose
Cardiovascular Disease (CKD), Hyperphosphatemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education (Edu)
SM intervention
Social Cognitive Therapy (SCT)
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Disease (CKD) focused on measuring Hemodialysis
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Education (Edu)
Edu + Self-Monitoring (SM)
Edu + SM + Social Cognitive Theory (SCT)
Arm Description
Outcomes
Primary Outcome Measures
Proportion of Hemodialysis (HD) patients that are eligible for the study
Measure of feasibility
Proportion of eligible patients who agree to participate
Measure of feasibility
Proportion of enrolled participants who complete the study
Measure of Acceptability
Secondary Outcome Measures
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
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.
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02940743
Brief Title
Behavioral Management of Phosphorus in Hemodialysis Patients
Official Title
Behavioral Management of Phosphorus in Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease (CKD), Hyperphosphatemia
Keywords
Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education (Edu)
Arm Type
Active Comparator
Arm Title
Edu + Self-Monitoring (SM)
Arm Type
Active Comparator
Arm Title
Edu + SM + Social Cognitive Theory (SCT)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Education (Edu)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SM intervention
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Social Cognitive Therapy (SCT)
Intervention Description
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 Outcome Measure Information:
Title
Proportion of Hemodialysis (HD) patients that are eligible for the study
Description
Measure of feasibility
Time Frame
24 Weeks
Title
Proportion of eligible patients who agree to participate
Description
Measure of feasibility
Time Frame
24 Weeks
Title
Proportion of enrolled participants who complete the study
Description
Measure of Acceptability
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
8-item Morisky Medication Adherence Survey (MMAS-8)
Description
Used to measure Binder Adherence, has been shown to be a valid and reliable measure of antihypertensive medication adherence
Time Frame
24 Weeks
Title
Reported dietary energy, protein and phosphorus intake
Description
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.
Time Frame
2 Weeks
Title
Normalized protein catabolic rate (nPCR)
Description
The nPCR is an objective measure of protein intake in HD patients based on the accumulation of urea nitrogen in blood between dialysis treatments
Time Frame
24 Weeks
Title
Serum phosphorus.
Description
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.
Time Frame
24 Weeks
Title
Frequency and severity of participant symptoms assessed via an investigator-developed questionnaire
Description
(itching, bone and joint pain, cramping) and phosphorus binders (difficulty defecating, loose or watery stools) will be self-reported via an investigator-developed questionnaire.
Time Frame
24 Weeks
Title
Balance Wise Self-Efficacy for Restricting Dietary Sodium in Hemodialysis Scale
Description
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.
Time Frame
24 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Sevick, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavioral Management of Phosphorus in Hemodialysis Patients
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