A Family Intervention for Delirium Prevention

NCT01998997 | Completed

• 1 other identifier: 104385
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Delirium

Keywords

Delirium; Hospitalized elderly

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Rate of incident delirium in each of the 2 groups

  14 weeks

Other Outcomes (1)

• Difficulties in performing the intervention

  14 weeks

Study Arms (2)

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.

Behavioral: Family educational intervention

general health education

PLACEBO COMPARATOR

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

Behavioral: Family educational intervention

Interventions

Family educational intervention BEHAVIORAL

The intervention is an educational intervention directed towards delirium prevention specifically for family members of hospitalized seniors. Family members will be encouraged to perform specific interventions that may decrease incident delirium.

Family educational intervention; general health education

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• monidipa dasgupta, MD

  Lawson HRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medicine

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

CA (1)