Behavioral Management of Phosphorus in Hemodialysis Patients
30 de maio de 2018 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
19 anos a 89 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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 Ativo: 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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of Hemodialysis (HD) patients that are eligible for the study
Prazo: 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
Prazo: 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
Prazo: 24 Weeks
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Measure of Acceptability
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24 Weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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8-item Morisky Medication Adherence Survey (MMAS-8)
Prazo: 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
Prazo: 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)
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Mary Sevick, MD, New York University Medical School
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
23 de abril de 2018
Conclusão Primária (Real)
1 de maio de 2018
Conclusão do estudo (Real)
1 de maio de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
17 de outubro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de outubro de 2016
Primeira postagem (Estimativa)
21 de outubro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de maio de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de maio de 2018
Última verificação
1 de maio de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 16-00817
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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