Behavioral Management of Phosphorus in Hemodialysis Patients
30 de mayo de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10016
- New York University School of Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
19 años a 89 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Comparador activo: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Hemodialysis (HD) patients that are eligible for the study
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 24 Weeks
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Measure of Acceptability
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24 Weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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8-item Morisky Medication Adherence Survey (MMAS-8)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mary Sevick, MD, New York University Medical School
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de abril de 2018
Finalización primaria (Actual)
1 de mayo de 2018
Finalización del estudio (Actual)
1 de mayo de 2018
Fechas de registro del estudio
Enviado por primera vez
17 de octubre de 2016
Primero enviado que cumplió con los criterios de control de calidad
19 de octubre de 2016
Publicado por primera vez (Estimar)
21 de octubre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de mayo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
30 de mayo de 2018
Última verificación
1 de mayo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 16-00817
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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