Behavioral Management of Phosphorus in Hemodialysis Patients
2018년 5월 30일 업데이트: NYU Langone Health
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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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New York, New York, 미국, 10016
- New York University School of Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
19년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Education (Edu)
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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.
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활성 비교기: Edu + Self-Monitoring (SM)
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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).
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활성 비교기: Edu + SM + Social Cognitive Theory (SCT)
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Hemodialysis (HD) patients that are eligible for the study
기간: 24 Weeks
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Measure of feasibility
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24 Weeks
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Proportion of eligible patients who agree to participate
기간: 24 Weeks
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Measure of feasibility
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24 Weeks
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Proportion of enrolled participants who complete the study
기간: 24 Weeks
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Measure of Acceptability
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24 Weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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8-item Morisky Medication Adherence Survey (MMAS-8)
기간: 24 Weeks
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Used to measure Binder Adherence, has been shown to be a valid and reliable measure of antihypertensive medication adherence
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24 Weeks
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Reported dietary energy, protein and phosphorus intake
기간: 2 Weeks
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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.
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2 Weeks
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Normalized protein catabolic rate (nPCR)
기간: 24 Weeks
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The nPCR is an objective measure of protein intake in HD patients based on the accumulation of urea nitrogen in blood between dialysis treatments
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24 Weeks
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Serum phosphorus.
기간: 24 Weeks
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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.
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24 Weeks
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Frequency and severity of participant symptoms assessed via an investigator-developed questionnaire
기간: 24 Weeks
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(itching, bone and joint pain, cramping) and phosphorus binders (difficulty defecating, loose or watery stools) will be self-reported via an investigator-developed questionnaire.
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24 Weeks
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Balance Wise Self-Efficacy for Restricting Dietary Sodium in Hemodialysis Scale
기간: 24 Weeks
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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.
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24 Weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mary Sevick, MD, New York University Medical School
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 4월 23일
기본 완료 (실제)
2018년 5월 1일
연구 완료 (실제)
2018년 5월 1일
연구 등록 날짜
최초 제출
2016년 10월 17일
QC 기준을 충족하는 최초 제출
2016년 10월 19일
처음 게시됨 (추정)
2016년 10월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 5월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 30일
마지막으로 확인됨
2018년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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