Health BehaviorNCT01622686
PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities
A study testing PictureRx medication label in people with Health Behavior and Medication Adherence, run by PictureRx, LLC at 1 site in United States.
Trial summary
This randomized controlled trial seeks to test the effect of reformatted prescription drug container labels, compared to usual labels, on participants' understanding of their medications. The study will also assess the effect on self-efficacy and self-reported medication adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Behavior, Medication Adherence
- What is being tested?
- PictureRx medication label
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to May 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years old,
- Fluency in English or Spanish
- Manage their own prescription medicines, and
- Have recently filled at least 1 new prescription medication (e.g, a medicine or medication dose that they have not taken before) and have their new prescription bottle information with them.
Who cannot join
- Excludes health professionals (such as a doctor, nurse or pharmacist)
- Too ill to participate in an interview
- Do not have a telephone
- Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart)
- Persons picking up new medicines for others
- Inability to communicate in either Spanish or English
- Overt psychiatric illnesses, overt delirium or dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
PictureRx, LLC (SAI Interactive)
Chattanooga, Tennessee, 37405
About this study
This randomized controlled trial seeks to test the effect of reformatted prescription drug container labels, compared to usual labels, on participants' understanding of their medications. The study will also assess the effect on self-efficacy and self-reported medication adherence. English and Spanish speaking patients are eligible, with a planned sample size of up to 500 adults.
- Conditions
- Health Behavior, Medication Adherence
- Being tested
- PictureRx medication label
- Keywords
- Prescription Labels, Low Health Literacy, Limited English Proficiency, Spanish
- Medical subject headings
- Health Behavior, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PictureRx medication labelBehavioural
Reformatted medication labels that adhere to current best practices for label design and also include illustrations
| Study group | Role | What they receive |
|---|---|---|
| Traditional prescription drug labels | No intervention | Routine drug labels provided by the participating pharmacies |
| Reformatted medication labels | Experimental | Prescription drug container labels that follow a new format and also include illustrations Receives: Behavioral: PictureRx medication label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient understanding of their medication regimen.
Patient understanding of the instructions for taking their medications correctly.
Measured: Approximately 7 days
Secondary outcomes (2)
Self-efficacy
Patients' confidence in being able to follow their medication regimen.
Measured: Approximately 7 days
Self-reported adherence
Patient self-reported adherence to the medications filled.
Measured: Approximately 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- PictureRx, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, M Brian Riley, PictureRx, LLC
- Investigators
- M Brian Riley, MA, Principal investigator, PictureRx, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622686
- Sponsor's protocol ID
- 1R43MD005805
- Other IDs
- 1R43MD005805-01
- Status last verified
- Jun 2012
- First submitted
- 11 Jun 2012
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities
- ClinicalTrials.gov ID
- NCT01622686
- Acronym / sponsor ID
- 1R43MD005805
- Conditions
- Health Behavior, Medication Adherence
- Keywords
- Prescription Labels, Low Health Literacy, Limited English Proficiency, Spanish
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- PictureRx, LLCUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Jun 2012 (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.
This randomized controlled trial seeks to test the effect of reformatted prescription drug container labels, compared to usual labels, on participants' understanding of their medications. The study will also assess the effect on self-efficacy and self-reported medication adherence. English and Spanish speaking patients are eligible, with a planned sample size of up to 500 adults.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional prescription drug labels | No intervention | –Routine drug labels provided by the participating pharmacies |
| Reformatted medication labels | Experimental | Behavioral: PictureRx medication labelPrescription drug container labels that follow a new format and also include illustrations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years old,
- Fluency in English or Spanish
- Manage their own prescription medicines, and
- Have recently filled at least 1 new prescription medication (e.g, a medicine or medication dose that they have not taken before) and have their new prescription bottle information with them.
Key exclusion criteria (7 listed)
- Excludes health professionals (such as a doctor, nurse or pharmacist)
- Too ill to participate in an interview
- Do not have a telephone
- Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart)
- Persons picking up new medicines for others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PictureRx medication labelReformatted medication labels that adhere to current best practices for label design and also include illustrations | Behavioural | Reformatted medication labels |
Primary outcome
Patient understanding of their medication regimen.
Time frame: Approximately 7 days
Patient understanding of the instructions for taking their medications correctly.
2 secondary outcomes
Self-efficacy
Time frame: Approximately 7 days
Self-reported adherence
Time frame: Approximately 7 days
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 19 Jun 2012.
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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.
M Brian Riley, MA principal investigator
PictureRx, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PictureRx medication label in people with Health Behavior and Medication Adherence, run by PictureRx, LLC 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 4 inclusion and 7 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 19 Jun 2012. 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?
Patient understanding of their medication regimen. (time frame: Approximately 7 days). 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 19 Jun 2012.