A Family Intervention for Delirium Prevention

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Monidipa Dasgupta, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01998997
First received: November 25, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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%.


Condition Intervention
Delirium
Behavioral: Family educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Family Intervention to Decrease Delirium: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • acceptance rate of intervention [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Difficulties in performing the intervention [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: March 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Family educational intervention
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
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.
Placebo Comparator: general health education
The placebo group will be given a brochure on good health habits

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).

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998997

Contacts
Contact: monidipa dasgupta, MD 519-685-8500 ext 33922# monidipa.Dasgupta@sjhc.london.on.ca

Locations
Canada, Ontario
University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Contact: monidipa dasgupta, md    519-685-8500 ext 33922#    monidipa.Dasgupta@sjhc.london.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: monidipa dasgupta, MD Lawson HRI
  More Information

No publications provided

Responsible Party: Monidipa Dasgupta, Associate Professor, Medicine, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01998997     History of Changes
Other Study ID Numbers: 104385
Study First Received: November 25, 2013
Last Updated: May 20, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Delirium
Hospitalized elderly

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014