跳至主要内容
临床试验/NCT01998997
NCT01998997已完成不适用

A Family Intervention to Decrease Delirium: a Pilot Study

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2014年3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
79
试验地点
1
主要终点
acceptance rate of intervention

研究概览

简要总结

To address the feasibility of implementing a randomized, educational intervention to prevent delirium, directed at family members of hospitalized older (70 years of age or older) medical in-patients. Specifically rates of recruitment and acceptance rates of such an intervention to family members will be assessed. An estimate of the effect size of this intervention will also be calculated. This is a pilot study. The investigators hypothesize that this intervention will be feasible and agreeable to family members to perform, with acceptance rates exceeding 80%.

详细描述

In a recent study in Chile, investigators randomized family members of admitted patients to an educational intervention to prevent delirium. Family members actively participated in a non-pharmacological intervention to prevent delirium. This has not been done in a North American environment, with different cultural and climactic factors.

This study will be a randomized controlled trial (pilot study) involving family members. Family members will be randomized to a control group or an educational intervention. The control group will receive a general brochure, outlining general health information published by the Ministry of Health. The intervention group will receive a specific brochure on details around delirium (what it is and how to prevent it), and then a brief educational session comprising a didactic session and to address any questions. This pilot study will examine the feasibility of doing this kind of intervention in a North American environment. The family-based intervention is similar to what was done in the Chilean study. It involves six elements including the educational session. The five other elements include: 1) family being present for extended periods (at least 5 hours if possible); 2) engaging in conversation with study patients for re-orientation to current time and current events; 3) avoiding sensory deprivation (ensuring hearing or visual aids and dentures are available as needed; 4) providing familiar objects to patients; 5) provision of a clock and calendar to the patient. The intervention brochure is similar to what was provided to family members as part of the original Chilean study (kindly provided to the principal investigator, M. Dasgupta, by the lead author of the Chilean study, Dr. F.T. Martinez).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • •Age 70 years or older
  • •Residing in the community
  • •Admitted to a general medical unit at the London Health Sciences center, University Campus
  • •Having a willing and interested English-speaking family member
  • •Not delirious on admission
  • •Able to communicate in English

排除标准

  • •Terminal condition
  • •Delirious on admission
  • •Advanced dementia
  • •Admission to the ICU (or transfer to the ICU within one week of admission)

研究组 & 干预措施

Family educational intervention

Active Comparator

A family educational, non-pharmacologic intervention will be administered to educate family members on how to prevent delirium. Family members will be encouraged to actively participate in this non-pharmacologic intervention.

干预措施: Family educational intervention (Behavioral)

general health education

Placebo Comparator

The placebo group will be given a brochure on good health habits

干预措施: Family educational intervention (Behavioral)

结局指标

主要结局

acceptance rate of intervention

时间窗: 14 weeks

This is a feasibility study aiming to assess the acceptance of an intervention directed at family members. The acceptance rate will therefore be the primary outcome.

次要结局

  • Rate of incident delirium in each of the 2 groups(14 weeks)

研究者

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

Monidipa Dasgupta

Associate Professor, Medicine

Lawson Health Research Institute

研究点 (1)

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