Behavioral Management of Phosphorus in Hemodialysis Patients

NYU Langone Health

Status: Completed

Conditions: Hyperphosphatemia; Cardiovascular Disease (CKD)

Treatments: Behavioral: SM intervention; Behavioral: Education (Edu); Behavioral: Social Cognitive Therapy (SCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02940743

16-00817

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Education (Edu)

Active Comparator group

Treatment:

Behavioral: Education (Edu)

Edu + Self-Monitoring (SM)

Active Comparator group

Treatment:

Behavioral: SM intervention

Behavioral: Education (Edu)

Edu + SM + Social Cognitive Theory (SCT)

Active Comparator group

Treatment:

Behavioral: SM intervention

Behavioral: Education (Edu)

Behavioral: Social Cognitive Therapy (SCT)