Behavioral Management of Phosphorus in Hemodialysis Patients
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedStudy Start
First participant enrolled
April 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 31, 2018
May 1, 2018
8 days
October 17, 2016
May 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Proportion of Hemodialysis (HD) patients that are eligible for the study
Measure of feasibility
24 Weeks
Proportion of eligible patients who agree to participate
Measure of feasibility
24 Weeks
Proportion of enrolled participants who complete the study
Measure of Acceptability
24 Weeks
Secondary Outcomes (6)
8-item Morisky Medication Adherence Survey (MMAS-8)
24 Weeks
Reported dietary energy, protein and phosphorus intake
2 Weeks
Normalized protein catabolic rate (nPCR)
24 Weeks
Serum phosphorus.
24 Weeks
Frequency and severity of participant symptoms assessed via an investigator-developed questionnaire
24 Weeks
- +1 more secondary outcomes
Study Arms (3)
Education (Edu)
ACTIVE COMPARATOREdu + Self-Monitoring (SM)
ACTIVE COMPARATOREdu + SM + Social Cognitive Theory (SCT)
ACTIVE COMPARATORInterventions
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.
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).
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.
Eligibility Criteria
You may qualify if:
- Receiving thrice-weekly hemodialysis treatment for at least 3 months
- month average serum phosphorus concentration \>5.5 mg/dL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Sevick, MD
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2016
First Posted
October 21, 2016
Study Start
April 23, 2018
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
May 31, 2018
Record last verified: 2018-05