跳至主要内容
临床试验/NCT02295462
NCT02295462已完成不适用

Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial

Martin-Luther-Universität Halle-Wittenberg3 个研究点 分布在 1 个国家目标入组 1,158 人开始时间: 2014年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,158
试验地点
3
主要终点
Proportion of residents receiving at least one antipsychotic medication after 12 months

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •On cluster level
  • •Inclusion Criteria:
  • •nursing homes with at least 50 residents

排除标准

  • •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

研究组 & 干预措施

Person-centered Care

Experimental

Medication Review + Person-centered Care

干预措施: Optimised Treatment (Other)

Optimised Treatment

Active Comparator

Medication Review

干预措施: Optimised Treatment (Other)

Person-centered Care

Experimental

Medication Review + Person-centered Care

干预措施: Person-centered Care (Other)

结局指标

主要结局

Proportion of residents receiving at least one antipsychotic medication after 12 months

时间窗: 12 months

次要结局

  • Residents' quality of life(12 months)
  • Behavioural and psychological symptoms of dementia(12 months)
  • Costs within trial period(12 months)
  • Falls and fall-related medical attention(12 months)
  • Physical restraints within study period(12 months)
  • Median daily dose of antipsychotics in chlorpromazine equivalents within study period(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriele Meyer

Prof. Dr.

Martin-Luther-Universität Halle-Wittenberg

研究点 (3)

Loading locations...

相似试验

Effect of Person-Centred-Care on Antipsychotic Drug... | 临床试验