Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Patient Education on Benzodiazepine Use in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02478593
Recruitment Status : Unknown
Verified May 2016 by Charles MacLean, MD, University of Vermont.
Recruitment status was:  Active, not recruiting
First Posted : June 23, 2015
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Charles MacLean, MD, University of Vermont

Brief Summary:
The overall goal of this research is to develop and test strategies to decrease potentially inappropriate medication use among the elderly.

Condition or disease Intervention/treatment Phase
Anxiety Insomnia Behavioral: Educational booklet Not Applicable

Detailed Description:
Specifically, the purpose of the study is to determine whether direct patient education is effective in decreasing benzodiazepine use in seniors.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of Patient Education on Benzodiazepine Use in the Elderly
Study Start Date : June 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: Experimental group
Group to receive educational booklet regarding risk/benefits of Benzodiazepine.
Behavioral: Educational booklet
Participants in the intervention group will receive an 8-page booklet that includes a list of generic and brand benzodiazepine names, benzodiazepine medication knowledge test, information about the associated risks of benzodiazepine use, and a list of safe alternative to their potentially inappropriate medication, as well as a stepwise tapering method. Recommendations to discuss decreasing use of benzodiazepines with physicians as well as to consult physicians before stopping any medication are also advised in the booklet. Participants in the control group will receive a booklet, produced by the Centers for Disease Control and Prevention, containing information regarding the important of exercise for seniors.

No Intervention: Control group
Group to receive educational booklet regarding risk/benefits of exercise.



Primary Outcome Measures :
  1. Benzodiazepine or non-benzodiazepine hypnotic medication use [ Time Frame: Baseline and 6 months post-intervention ]
    Proportion of subjects using benzodiazepine or non-benzodiazepine hypnotic medication (such as zolpidem)


Secondary Outcome Measures :
  1. Patient attempt to discontinuing benzodiazepine [ Time Frame: 1 month and 6 months post-intervention ]
    Novel patient reported measure regarding attempts to discontinue medication

  2. Patient knowledge regarding benzodiazepines [ Time Frame: Baseline and 6 months post-intervention ]
    Novel patient reported measure regarding knowledge of the potential risks and benefits of benzodiazepines

  3. Belief about Medicines Questionnaire (BMQ) [ Time Frame: Baseline and 6 months post-intervention ]
    This is a validated instrument assessing patient beliefs regarding medication efficacy and safety



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women
  • Full benefit members living in a SASH facility
  • 60 years old or older
  • Using at least 1 active short/medium/long acting benzodiazepine at time of recruitment

Exclusion Criteria:

  • Inability to provide consent
  • Inability to communicate in English
  • Diagnosis of severe mental illness, dementia, seizure disorder

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): NCT02478593


Sponsors and Collaborators
University of Vermont
Investigators
Layout table for investigator information
Principal Investigator: Charles MacLean, MD University of Vermont

Publications of Results:

Layout table for additonal information
Responsible Party: Charles MacLean, MD, Professor of Medicine, Primary Care Internal Medicine, Department of Medicine Associate Dean for Primary Care, University of Vermont
ClinicalTrials.gov Identifier: NCT02478593     History of Changes
Other Study ID Numbers: 00000485
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by Charles MacLean, MD, University of Vermont:
Education
Geriatric
Benzodiazepine
Prevalence
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders