Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-05 @ 4:27 PM
Study NCT ID:
NCT02188134
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2014-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection
Sponsor:
Michigan State University
Organization:
Study Overview
Official Title:
Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Per-capita consumption of medication is higher in older adults than any other sector of the population. In fact, it has been estimated that although older adults comprise 13% of the population they take 34% of all prescriptions and 30% of the over-the-counter (OTCs) consumed in the US (National Council on Patient Information and Education, 2010). Given current trends in aging, the savings, freedom and flexibility that self-medicating provides, as well as the trends to switch prescription products to an OTC status, it is likely that older adults will increasingly turn to OTCs as part of their medical regimens for years to come (Hanlon, J et al, 2001).
In addition to the advantages that self-medicating offers, there are risks. These risks are more pronounced in older consumers, who are likely experiencing physiological changes (e.g. pharmacokinetics, pharmacodynamics, perceptual, cognitive and motor); this combines with a propensity for poly-pharmacy that escalates the likelihood of adverse drug reactions. It has also been suggested that low health literacy rates in older consumers detrimentally impact health and health outcomes in this population (Kutner et al., 2005 and Federman et al., 2009).
Despite the risks associated with improper OTC use, the critical importance of OTC labeling information (there is no learned intermediary), and the fact that older consumers are significantly more likely to experience an adverse drug reaction than younger adults, surprisingly little information exists about the decision making process older adults employ when selecting and using an OTC product.
We propose to recruit people 65 and older for an eye tracking study of mock OTC brands. The study has the following objectives:
1. To begin to garner insights regarding the proportion of subjects who closely examine (e.g. turn to the Drug Facts Label) the labeling of an OTC when deciding whether (or not) a drug is appropriate for them (based on their health history and current medications).
2. To quantify and compare the attentive behaviors to specific information (Specifically: name, active ingredient, symptom relief).
3. To quantify and compare the attentive behaviors to different formats of information (prominently featured information vs less prominently featured information).
4. To begin to benchmark whether or not older consumers make appropriate choices based on their current conditions and medication history.
In addition to the advantages that self-medicating offers, there are risks. These risks are more pronounced in older consumers, who are likely experiencing physiological changes (e.g. pharmacokinetics, pharmacodynamics, perceptual, cognitive and motor); this combines with a propensity for poly-pharmacy that escalates the likelihood of adverse drug reactions. It has also been suggested that low health literacy rates in older consumers detrimentally impact health and health outcomes in this population (Kutner et al., 2005 and Federman et al., 2009).
Despite the risks associated with improper OTC use, the critical importance of OTC labeling information (there is no learned intermediary), and the fact that older consumers are significantly more likely to experience an adverse drug reaction than younger adults, surprisingly little information exists about the decision making process older adults employ when selecting and using an OTC product.
We propose to recruit people 65 and older for an eye tracking study of mock OTC brands. The study has the following objectives:
1. To begin to garner insights regarding the proportion of subjects who closely examine (e.g. turn to the Drug Facts Label) the labeling of an OTC when deciding whether (or not) a drug is appropriate for them (based on their health history and current medications).
2. To quantify and compare the attentive behaviors to specific information (Specifically: name, active ingredient, symptom relief).
3. To quantify and compare the attentive behaviors to different formats of information (prominently featured information vs less prominently featured information).
4. To begin to benchmark whether or not older consumers make appropriate choices based on their current conditions and medication history.
Detailed Description:
Eligibility Criteria 65 or older Administer own medications Legally sighted Purchase over-the-counter medications on occasion Be willing to share complete health history and complete list of all OTC and prescription medications Have transportation to one of two test sites (MSU Campus or Lansing Ingham County Building)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: