Hyperphosphatemia Clinical Trial
Official title:
Behavioral Management of Phosphorus in Hemodialysis
NCT number | NCT02940743 |
Other study ID # | 16-00817 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 23, 2018 |
Est. completion date | May 1, 2018 |
Verified date | May 2018 |
Source | New York University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 1, 2018 |
Est. primary completion date | May 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 89 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | New York University School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Hemodialysis (HD) patients that are eligible for the study | Measure of feasibility | 24 Weeks | |
Primary | Proportion of eligible patients who agree to participate | Measure of feasibility | 24 Weeks | |
Primary | Proportion of enrolled participants who complete the study | Measure of Acceptability | 24 Weeks | |
Secondary | 8-item Morisky Medication Adherence Survey (MMAS-8) | Used to measure Binder Adherence, has been shown to be a valid and reliable measure of antihypertensive medication adherence | 24 Weeks | |
Secondary | Reported dietary energy, protein and phosphorus intake | 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. | 2 Weeks | |
Secondary | Normalized protein catabolic rate (nPCR) | The nPCR is an objective measure of protein intake in HD patients based on the accumulation of urea nitrogen in blood between dialysis treatments | 24 Weeks | |
Secondary | Serum phosphorus. | 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. | 24 Weeks | |
Secondary | Frequency and severity of participant symptoms assessed via an investigator-developed questionnaire | (itching, bone and joint pain, cramping) and phosphorus binders (difficulty defecating, loose or watery stools) will be self-reported via an investigator-developed questionnaire. | 24 Weeks | |
Secondary | Balance Wise Self-Efficacy for Restricting Dietary Sodium in Hemodialysis Scale | 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. | 24 Weeks |
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