- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02295462
Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial (EPCentCare)
Background: Up to 90% of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs seem to be prescribed as first line treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed for inappropriate reasons and too long without regular review. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. This study aims to investigate whether a person-centered care approach developed in the United Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators trial is to achieve a clinically relevant reduction of the proportion of residents with alt least one antipsychotic drug prescription.
Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day initial skill training on person-centred care and on-going training and support programme) with a control group receiving optimised usual care. Both study groups will receive a medication review by an experienced psychiatrist with feedback to the prescribing physician. Overall, 36 nursing homes from East, North and West Germany will be included and randomised. The primary outcome is defined as the proportion of residents receiving at least one antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life, behavioural and psychological symptoms of dementia as well as safety parameters like falls and fall-related medical attention. Cost parameters will be collected and process evaluation will be performed alongside the trial.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Nordrhein-Westfalen
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Witten Herdecke, Nordrhein-Westfalen, Alemanha, 58448
- Universität Witten/Herdecke
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Sachsen-Anhalt
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Halle (Saale), Sachsen-Anhalt, Alemanha, 06110
- Martin-Luther-Universität Halle-Wittenberg
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Alemanha, 23562
- University of Luebeck
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
On cluster level
Inclusion Criteria:
- nursing homes with at least 50 residents
Exclusion Criteria:
- other ongoing trial in the institution
On individual level
Inclusion Criteria:
- all residents within a cluster are eligible to participate in the study
Exclusion Criteria:
- diagnoses of schizophrenia, schizoaffective psychosis, or other forms of primary psychosis
- respite care
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Person-centered Care
Medication Review + Person-centered Care
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Medication Review + Person-centered Care
Medication Review only
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Comparador Ativo: Optimised Treatment
Medication Review
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Medication Review only
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Proportion of residents receiving at least one antipsychotic medication after 12 months
Prazo: 12 months
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12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Residents' quality of life
Prazo: 12 months
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Will be measured with the QoL-AD
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12 months
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Behavioural and psychological symptoms of dementia
Prazo: 12 months
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Will be measured with the CMAI
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12 months
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Costs within trial period
Prazo: 12 months
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Cost parameters will be collected alongside the trial on intervention-related components as well as outcome-related components.
Costs which are explicitly trial-associated will not be taken into account for cost analysis.
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12 months
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Falls and fall-related medical attention
Prazo: 12 months
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12 months
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Physical restraints within study period
Prazo: 12 months
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Physical restraints will be assessed retrospectively by data extraction from residents' records- The following devices will be assessed: bilateral bedrails, belts, fixed tables, and other measures limiting free body movement.
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12 months
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Median daily dose of antipsychotics in chlorpromazine equivalents within study period
Prazo: 12 months
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Each resident's daily dose of antipsychotic drugs will be translated into chlorpromazine daily equivalents.
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12 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Process evaluation
Prazo: 12 months
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Different methods will be used for data collection: investigators documentation, questionnaires on staff knowledge and self-efficacy, structured interviews and in depth-interviews with staff.
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gabriele Meyer, Prof. Dr., Martin-Luther-Universität Halle-Wittenberg
Publicações e links úteis
Publicações Gerais
- Richter C, Fleischer S, Langner H, Meyer G, Balzer K, Kopke S, Sonnichsen A, Loscher S, Berg A. Factors influencing the implementation of person-centred care in nursing homes by practice development champions: a qualitative process evaluation of a cluster-randomised controlled trial (EPCentCare) using Normalization Process Theory. BMC Nurs. 2022 Jul 8;21(1):182. doi: 10.1186/s12912-022-00963-6.
- Richter C, Berg A, Langner H, Meyer G, Kopke S, Balzer K, Wolschon EM, Silies K, Sonnichsen A, Loscher S, Haastert B, Icks A, Wolf U, Fleischer S. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): a cluster-randomised controlled trial. Age Ageing. 2019 May 1;48(3):419-425. doi: 10.1093/ageing/afz016.
- Dichter MN, Wolschon EM, Schwab CGG, Meyer G, Kopke S. Item distribution and inter-rater reliability of the German version of the quality of life in Alzheimer's disease scale (QoL-AD) proxy for people with dementia living in nursing homes. BMC Geriatr. 2018 Jun 19;18(1):145. doi: 10.1186/s12877-018-0834-z.
- Richter C, Berg A, Fleischer S, Kopke S, Balzer K, Fick EM, Sonnichsen A, Loscher S, Vollmar HC, Haastert B, Icks A, Dintsios CM, Mann E, Wolf U, Meyer G. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial. Implement Sci. 2015 Jun 4;10:82. doi: 10.1186/s13012-015-0268-3.
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 (Real)
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
- EPCentCare
- 01GY1335A (Número de outro subsídio/financiamento: German Federal Ministry of Education and Research)
- 01GY1335B (Número de outro subsídio/financiamento: German Federal Ministry of Education and Research)
- 01GY1335C (Número de outro subsídio/financiamento: German Federal Ministry of Education and Research)
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