Nurse-led Intervention to Improve Phosphate Binder Adherence (MedAM)
A Nurse-led Multifactorial Intervention to Improve Phosphate Binder Adherence: Results From a One-year Clinical Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background Phosphate binder nonadherence is ubiquitous. The results of adherence enhancing interventions are often disappointing. The aim is to test a nurse-led multifactorial intervention to enhance phosphate binder adherence.
Methods In a quasi-experimental clinical trial, phosphate binder adherence was measured electronically in 135 hemodialysis patients for one year and phosphatemia measured monthly. For all patients, months 1-2 were baseline (no interventions were performed). The intervention arm was given 1 "preparatory" intervention and then monthly 8 "maintenance" individualized management sessions. The control arm received standard of care.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Antwerpen, Bélgica
- Dialysis hospital unit 1
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Antwerpen, Bélgica
- Dialysis hospital unit 3
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Turnhout, Bélgica
- Dialysis hospital unit 2
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- adult (≥18)
- chronic hemodialysis ≥1 month
- treated with phosphate binders
- Dutch-speaking
Exclusion Criteria:
- receiving professional medication care
- cognitive impairment
- nursing home residents
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: Braço de controle
Cuidado padrão
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Experimental: Adherence support
One-time preparatory intervention offering adherence prerequisites (knowledge, social support and skills) + One-year monthly individualised counselling sessions with a standardised intervention sheet listing the most prevalent problems with possible solutions |
One-time preparatory intervention offering adherence prerequisites (knowledge, social support and skills) + One-year monthly individualised counselling sessions with a standardised intervention sheet listing the most prevalent problems with possible solutions
Outros nomes:
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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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Medication adherence
Prazo: One year
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The intake of medication (phosphate binders) was monitored continuously for one year through electronic monitoring with the Medication Event Monitoring System (MEMS). Medication containers are filled with patients' phosphate binders and then capped with MEMS-caps registering the time and date of each opening and thus presumed intake of the medication in the box. Mean adherence was calculated as the proportion of prescribed doses taken, averaged per month (e.g. patients with a ter in die regimen (84 doses/month) and taking them all 84 would have a mean adherence of 84/84=100%). Nonadherence was defined as a mean adherence <80%. |
One year
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Serum phosphate
Prazo: Monthly for one year
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Serum phosphate was gathered monthly from patients' charts.
In addition to mean serum phosphate per month we dichtomised this outcome measure with >5mg/dL representing uncontrolled phosphatemia.
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Monthly for one year
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Patient knowledge
Prazo: At study start and end (after one year)
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Knowledge was measured by ten multiple-choice questions about the phosphate cycle, phosphate binder pharmacodynamics and dietary recommendations, developed in previous research and added as appendix in a previous article (Van Camp Y, Vrijens B, Abraham I, et al.
Adherence to phosphate binders in hemodialysis patients: prevalence and determinants.
J Nephrol 2013; JNEPHROL-D-13-00176R1: Publicatin in process)
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At study start and end (after one year)
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Social support
Prazo: At study start and end (after one year)
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Social support was measured by eleven questions assessing perceived support in general and support with taking phosphate binders specifically, developed in previous research and added as appendix in a previous article (Van Camp Y, Vrijens B, Abraham I, et al.
Adherence to phosphate binders in hemodialysis patients: prevalence and determinants.
J Nephrol 2013; JNEPHROL-D-13-00176R1: publication in process)
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At study start and end (after one year)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yoleen PM Van Camp, MScN, Universiteit Antwerpen
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UA-B300201111744
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