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A Family Intervention for Delirium Prevention

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ClinicalTrials.gov Identifier: NCT01998997
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):

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%.

Condition or disease Intervention/treatment
Delirium Behavioral: Family educational intervention

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).


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Family Intervention to Decrease Delirium: a Pilot Study
Study Start Date : March 2014
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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.


Outcome Measures

Primary Outcome Measures :
  1. acceptance rate of intervention [ Time Frame: 14 weeks ]
    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 :
  1. Rate of incident delirium in each of the 2 groups [ Time Frame: 14 weeks ]
    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:
  1. Difficulties in performing the intervention [ Time Frame: 14 weeks ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998997


Locations
Canada, Ontario
University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: monidipa dasgupta, MD Lawson HRI
More Information

Responsible Party: Monidipa Dasgupta, Associate Professor, Medicine, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01998997     History of Changes
Other Study ID Numbers: 104385
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015

Keywords provided by Monidipa Dasgupta, Lawson Health Research Institute:
Delirium
Hospitalized elderly

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders