Older Adults (65 Years and Older)NCT02188134
Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection
An observational study of Older Adults (65 Years and Older), run by Michigan State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults (65 Years and Older)
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 65 and older self administer medication Purchase OTCs
Who may be able to join
- 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
Who cannot join
- Legally blind Does not use OTC medications Less than 65 Does not administer own medication
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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:
- 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).
- To quantify and compare the attentive behaviors to specific information (Specifically: name, active ingredient, symptom relief).
- To quantify and compare the attentive behaviors to different formats of information (prominently featured information vs less prominently featured information).
- To begin to benchmark whether or not older consumers make appropriate choices based on their current conditions and medication history.
Read the 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)
- Conditions
- Older Adults (65 Years and Older)
- Keywords
- Adverse events,, adverse drug reactions,, medication error,, noncompliance
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 65 and older | No intervention will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in zone
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.
Measured: Measure taken in a single session with participant
Time to first hit
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.
Measured: Measure taken in a single session with participant
Number of visual hits
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
Measured: Measure taken in a single session with participant
Appropriate product selection
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
Measured: Measure taken in a single session with participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (65 Years and Older)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Consumer Healthcare Products Association
- Responsible party
- Principal investigator, Laura Bix, Michigan State University
- Investigators
- Laura Bix, PhD, Principal investigator, Michigan State Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188134
- Sponsor's protocol ID
- MSU14-679
- Status last verified
- Apr 2015
- First submitted
- 8 Jul 2014
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection
- ClinicalTrials.gov ID
- NCT02188134
- Acronym / sponsor ID
- MSU14-679
- Conditions
- Older Adults (65 Years and Older)
- Keywords
- Adverse events,, adverse drug reactions,, medication error,, noncompliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Consumer Healthcare Products Association
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- To quantify and compare the attentive behaviors to specific information (Specifically: name, active ingredient, symptom relief).
- To quantify and compare the attentive behaviors to different formats of information (prominently featured information vs less prominently featured information).
- 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 design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 65 and older | – | –No intervention will be administered |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 65 and older self administer medication Purchase OTCs
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Legally blind Does not use OTC medications Less than 65 Does not administer own medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Bix, PhD principal investigator
Michigan State Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Older Adults (65 Years and Older), run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in zone (time frame: Measure taken in a single session with participant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.