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Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection

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ClinicalTrials.gov Identifier: NCT02188134
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : April 7, 2015
Sponsor:
Collaborator:
Consumer Healthcare Products Association
Information provided by (Responsible Party):
Laura Bix, Michigan State University

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.

Condition or disease
Older Adults (65 Years and Older)

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)

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Study Type : Observational
Actual Enrollment : 82 participants
Time Perspective: Cross-Sectional
Official Title: Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Group/Cohort
65 and older
No intervention will be administered



Primary Outcome Measures :
  1. Time in zone [ Time Frame: Measure taken in a single session with participant ]

    Eye tracking will be done while mock OTCs appear on a computer screen, and participants will be asked to make a binary choice (yes/no) regarding whether (or not) the drug is safe choice for them at present.

    Treatments will appear in random order . Subjects will be asked to answer the question, "Assuming you have this condition, is this product appropriate for you?" for each of the twenty-seven trials while we track the movement of the eye.

    Zones for the analysis of the data include product name, symptom relief and active ingredient. Time in zone is the amount of time a subject's eye spends on the targeted information.


  2. Time to first hit [ Time Frame: Measure taken in a single session with participant ]

    Eye tracking will be done while mock OTCs appear on a computer screen, and participants will be asked to make a binary choice (yes/no) regarding whether (or not) the drug is safe choice for them at present.

    Treatments will appear in random order . Subjects will be asked to answer the question, "Assuming you have this condition, is this product appropriate for you?" for each of the twenty-seven trials while we track the movement of the eye.

    Zones for the analysis of the data include product name, symptom relief and active ingredient. Time to first hit is the measure of time it takes for a subject to fixate information in the zones described above.


  3. Number of visual hits [ Time Frame: Measure taken in a single session with participant ]

    Eye tracking will be done while mock OTCs appear on a computer screen, and participants will be asked to make a binary choice (yes/no) regarding whether (or not) the drug is safe choice for them at present.

    Treatments will appear in random order . Subjects will be asked to answer the question, "Assuming you have this condition, is this product appropriate for you?" for each of the twenty-seven trials while we track the movement of the eye.

    Zones for the analysis of the data include product name, symptom relief and active ingredient. Number of visual hits is the number of times the eye returns to a given information zone


  4. Appropriate product selection [ Time Frame: Measure taken in a single session with participant ]

    Eye tracking will be done while mock OTCs appear on a computer screen, and participants will be asked to make a binary choice (yes/no) regarding whether (or not) the drug is safe choice for them at present.

    Treatments will appear in random order . Subjects will be asked to answer the question, "Assuming you have this condition, is this product appropriate for you?" for each of the twenty-seven trials while we track the movement of the eye.

    Based on the self-reported history that is provided during a guided interview, and the medications that they have brought with them, an assessment will be made regarding the "correctness" of their response to whether or not the drug is an appropriate choice for them




Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
65 and older self administer medication Purchase OTCs
Criteria

Inclusion Criteria:

  • 65 or older legally sighted administer own medication purchase OTC have transportation to one of two test sites Be willing to share a complete health history and complete list of medications

Exclusion Criteria:

  • Legally blind Does not use OTC medications Less than 65 Does not administer own medication

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): NCT02188134


Locations
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United States, Michigan
Packaging Building
East Lansing, Michigan, United States, 48824
Sponsors and Collaborators
Michigan State University
Consumer Healthcare Products Association
Investigators
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Principal Investigator: Laura Bix, PhD Michigan State Univeristy

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Responsible Party: Laura Bix, Associate Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT02188134     History of Changes
Other Study ID Numbers: MSU14-679
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Laura Bix, Michigan State University:
Adverse events,
adverse drug reactions,
medication error,
noncompliance