Impact of Patient Education on Benzodiazepine Use in the Elderly
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|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
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Insomnia||Behavioral: Educational booklet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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|
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.
- 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)
- Patient attempt to discontinuing benzodiazepine [ Time Frame: 1 month and 6 months post-intervention ]Novel patient reported measure regarding attempts to discontinue medication
- 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
- 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
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
|Principal Investigator:||Charles MacLean, MD||University of Vermont|