Cardiovascular Disease (CKD)NCT02940743
Behavioral Management of Phosphorus in Hemodialysis Patients
A study testing Education (Edu), SM intervention and Social Cognitive Therapy (SCT) in people with Cardiovascular Disease (CKD) and Hyperphosphatemia, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 89 years
- Conditions the study is for
- Cardiovascular Disease (CKD), Hyperphosphatemia
- What is being tested?
- Education (Edu), SM intervention and Social Cognitive Therapy (SCT)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving thrice-weekly hemodialysis treatment for at least 3 months
- 3-month average serum phosphorus concentration >5.5 mg/dL
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Disease (CKD), Hyperphosphatemia
- Being tested
- Education (Edu), SM intervention, Social Cognitive Therapy (SCT)
- Keywords
- Hemodialysis
- Medical subject headings
- Cardiovascular Diseases, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education (Edu)Behavioural
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.
SM interventionBehavioural
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).
Social Cognitive Therapy (SCT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education (Edu) | Active comparator | Not described Receives: Behavioral: Education (Edu) |
| Edu + Self-Monitoring (SM) | Active comparator | Not described Receives: Behavioral: Education (Edu); Behavioral: SM intervention |
| Edu + SM + Social Cognitive Theory (SCT) | Active comparator | Not described Receives: Behavioral: Education (Edu); Behavioral: SM intervention; Behavioral: Social Cognitive Therapy (SCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Hemodialysis (HD) patients that are eligible for the study
Measure of feasibility
Measured: 24 Weeks
Proportion of eligible patients who agree to participate
Measure of feasibility
Measured: 24 Weeks
Proportion of enrolled participants who complete the study
Measure of Acceptability
Measured: 24 Weeks
Secondary outcomes (6)
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
Measured: 24 Weeks
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.
Measured: 2 Weeks
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
Measured: 24 Weeks
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.
Measured: 24 Weeks
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.
Measured: 24 Weeks
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.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start23 Apr 2018
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease (CKD)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Sevick, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940743
- Sponsor's protocol ID
- 16-00817
- Status last verified
- May 2018
- First submitted
- 17 Oct 2016
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Management of Phosphorus in Hemodialysis
- ClinicalTrials.gov ID
- NCT02940743
- Acronym / sponsor ID
- 16-00817
- Conditions
- Cardiovascular Disease (CKD), Hyperphosphatemia
- Keywords
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education (Edu) | Active comparator | Behavioral: Education (Edu) |
| Edu + Self-Monitoring (SM) | Active comparator | Behavioral: Education (Edu), Behavioral: SM intervention |
| Edu + SM + Social Cognitive Theory (SCT) | Active comparator | Behavioral: Education (Edu), Behavioral: SM intervention, Behavioral: Social Cognitive Therapy (SCT) |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving thrice-weekly hemodialysis treatment for at least 3 months
- 3-month average serum phosphorus concentration >5.5 mg/dL
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education (Edu)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. | Behavioural | Edu + SM + Social Cognitive Theory (SCT), Edu + Self-Monitoring (SM), Education (Edu) |
| SM interventionDuring 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). | Behavioural | Edu + SM + Social Cognitive Theory (SCT), Edu + Self-Monitoring (SM) |
| Social Cognitive Therapy (SCT)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. | Behavioural | Edu + SM + Social Cognitive Theory (SCT) |
Primary outcome
Proportion of Hemodialysis (HD) patients that are eligible for the study
Time frame: 24 Weeks
Measure of feasibility
Proportion of eligible patients who agree to participate
Time frame: 24 Weeks
Measure of feasibility
Proportion of enrolled participants who complete the study
Time frame: 24 Weeks
Measure of Acceptability
6 secondary outcomes
8-item Morisky Medication Adherence Survey (MMAS-8)
Time frame: 24 Weeks
Reported dietary energy, protein and phosphorus intake
Time frame: 2 Weeks
Normalized protein catabolic rate (nPCR)
Time frame: 24 Weeks
Serum phosphorus.
Time frame: 24 Weeks
Frequency and severity of participant symptoms assessed via an investigator-developed questionnaire
Time frame: 24 Weeks
Balance Wise Self-Efficacy for Restricting Dietary Sodium in Hemodialysis Scale
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Sevick, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education (Edu), SM intervention and Social Cognitive Therapy (SCT) in people with Cardiovascular Disease (CKD) and Hyperphosphatemia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Hemodialysis (HD) patients that are eligible for the study (time frame: 24 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.