Behavioral Management of Phosphorus in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hyperphosphatemia; Cardiovascular Disease (CKD)
• Interventions: Behavioral: Education (Edu); Behavioral: SM intervention; Behavioral: Social Cognitive Therapy (SCT)

• Registration Number: NCT02940743
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Study Start: 2018-04-23
• Status Verified: 2018-05
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edu + Self-Monitoring (SM)	SM intervention	-
Edu + SM + Social Cognitive Theory (SCT)	SM intervention	-
Education (Edu)	Education (Edu)	-
Edu + SM + Social Cognitive Theory (SCT)	Social Cognitive Therapy (SCT)	-
Edu + SM + Social Cognitive Theory (SCT)	Education (Edu)	-
Edu + Self-Monitoring (SM)	Education (Edu)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Balance Wise Self-Efficacy for Restricting Dietary Sodium in Hemodialysis Scale	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.
Normalized protein catabolic rate (nPCR)	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.	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	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.
8-item Morisky Medication Adherence Survey (MMAS-8)	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	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States