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A Family Intervention for Delirium Prevention

Primary Purpose

Delirium

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Family educational intervention
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Delirium, Hospitalized elderly

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Family educational intervention

general health education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 25, 2013
Last Updated
December 23, 2015
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01998997
Brief Title
A Family Intervention for Delirium Prevention
Official Title
A Family Intervention to Decrease Delirium: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, Hospitalized elderly

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family educational intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
general health education
Arm Type
Placebo Comparator
Arm Description
The placebo group will be given a brochure on good health habits
Intervention Type
Behavioral
Intervention Name(s)
Family educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
acceptance rate of intervention
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Rate of incident delirium in each of the 2 groups
Description
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.
Time Frame
14 weeks
Other Pre-specified Outcome Measures:
Title
Difficulties in performing the intervention
Description
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.
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
monidipa dasgupta, MD
Organizational Affiliation
Lawson HRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Family Intervention for Delirium Prevention

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