Delirium Clinical Trial
Official title:
A Family Intervention to Decrease Delirium: a Pilot Study
Verified date | December 2015 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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%.
Status | Completed |
Enrollment | 79 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Terminal condition - Delirious on admission - Advanced dementia - Admission to the ICU (or transfer to the ICU within one week of admission) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | University Hospital | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difficulties in performing the intervention | Family members will be surveyed as to what may have been particular difficulties in the intervention to perform. This may help to re-design the intervention for future studies. | 14 weeks | No |
Primary | acceptance rate of intervention | 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. | 14 weeks | No |
Secondary | Rate of incident delirium in each of the 2 groups | The rate of incident delirium in each of the 2 (control or intervention) groups will be examined in order to calculate the sample size for a future similar intervention study. | 14 weeks | No |
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