Delirium Clinical Trial
Official title:
A Family Intervention to Decrease Delirium: a Pilot Study
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%.
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).
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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