Behavioral Management of Phosphorus in Hemodialysis Patients
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 19 - 89 |
| Updated: | 6/2/2018 |
| Start Date: | April 23, 2018 |
| End Date: | May 1, 2018 |
Behavioral Management of Phosphorus in Hemodialysis
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.
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.
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.
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.
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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Mary Sevick, MD
Phone: 212-263-4966
New York University School of Medicine NYU School of Medicine has a proud history that...
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