Clinical trial NCT02940743: Behavioral Management of Phosphorus in Hemodialysis Patients
Official title: Behavioral Management of Phosphorus in Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease (CKD)
Hyperphosphatemia
Keywords: Hemodialysis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of Hemodialysis (HD) patients that are eligible for the study
timeFrame: 24 Weeks
measure: Proportion of eligible patients who agree to participate
timeFrame: 24 Weeks
measure: Proportion of enrolled participants who complete the study
timeFrame: 24 Weeks
Secondary outcomes:
measure: 8-item Morisky Medication Adherence Survey (MMAS-8)
timeFrame: 24 Weeks
measure: Reported dietary energy, protein and phosphorus intake
timeFrame: 2 Weeks
measure: Normalized protein catabolic rate (nPCR)
timeFrame: 24 Weeks
measure: Serum phosphorus.
timeFrame: 24 Weeks
measure: Frequency and severity of participant symptoms assessed via an investigator-developed questionnaire
timeFrame: 24 Weeks
measure: Balance Wise Self-Efficacy for Restricting Dietary Sodium in Hemodialysis Scale
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Mary Sevick, MD
role: PRINCIPAL_INVESTIGATOR
References: