Understanding of Medication InstructionsNCT01618461
PictureRx: An Intervention to Reduce Latino Health Disparities (Supplement: Medical Icons)
A study testing Drug indication icons and Structured instructions in people with Understanding of Medication Instructions and Recall of Medication Instructions, run by PictureRx, LLC at 2 sites in United States.
Trial summary
Research shows that well-developed icons and other pictorials aid in the comprehension of medication information and are effective in improving patients' medication management. This experimental study seeks to test the effect of icons and structured medication information on subjects' processing and recall of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Understanding of Medication Instructions, Recall of Medication Instructions
- What is being tested?
- Drug indication icons and Structured instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Jul 2011
- 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
- Be taking at least one chronic medication
Who cannot join
- Too ill to complete the experiment
- Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart)
- Inability to communicate in either Spanish or English
- Overt psychiatric illnesses, overt delirium or dementia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Saint Thomas Family Health Center - West
Nashville, Tennessee, 37209
Saint Thomas Family Health Center - South
Nashville, Tennessee, 37211
About this study
Research shows that well-developed icons and other pictorials aid in the comprehension of medication information and are effective in improving patients' medication management. This experimental study seeks to test the effect of icons and structured medication information on subjects' processing and recall of simulated medication instructions in a computer testing environment. The study planned to enroll 200 subjects.
- Being tested
- Drug indication icons, Structured instructions
- Keywords
- Prescription drug information, Medication management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug indication iconsBehavioural
Icons illustrate the purpose of each medication
Structured instructionsBehavioural
Graphical format shows what time(s) of day each medication should be taken
| Study group | Role | What they receive |
|---|---|---|
| Text instructions | No intervention | Medication instructions displayed in text format |
| Drug indication icons | Experimental | Icons illustrate the purpose of each medication Receives: Behavioral: Drug indication icons |
| Structured instructions | Experimental | Graphical format shows what time(s) of day each medication should be taken Receives: Behavioral: Structured instructions |
| Icons + Structured instructions | Experimental | Icons illustrate the purpose of each medication, and a graphical format shows what time(s) of day each medication should be taken Receives: Behavioral: Drug indication icons; Behavioral: Structured instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of medication instructions
Participants' ability to state the drug indication
Measured: Within 10-20 minutes
Secondary outcomes (1)
Recall of medication instructions
Participants' ability to recall the instructions after viewing a series of medications
Measured: Within 10-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Understanding of Medication InstructionsStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 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
- NCT01618461
- Sponsor's protocol ID
- 3R43MD004048-02S1
- Other IDs
- 3R43MD004048-02S1
- Status last verified
- Jun 2012
- First submitted
- 11 Jun 2012
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PictureRx: An Intervention to Reduce Latino Health Disparities (Supplement: Medical Icons)
- ClinicalTrials.gov ID
- NCT01618461
- Acronym / sponsor ID
- 3R43MD004048-02S1
- Keywords
- Prescription drug information, Medication management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- PictureRx, LLCUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 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.
Research shows that well-developed icons and other pictorials aid in the comprehension of medication information and are effective in improving patients' medication management. This experimental study seeks to test the effect of icons and structured medication information on subjects' processing and recall of simulated medication instructions in a computer testing environment. The study planned to enroll 200 subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Text instructions | No intervention | –Medication instructions displayed in text format |
| Drug indication icons | Experimental | Behavioral: Drug indication iconsIcons illustrate the purpose of each medication |
| Structured instructions | Experimental | Behavioral: Structured instructionsGraphical format shows what time(s) of day each medication should be taken |
| Icons + Structured instructions | Experimental | Behavioral: Drug indication icons, Behavioral: Structured instructionsIcons illustrate the purpose of each medication, and a graphical format shows what time(s) of day each medication should be taken |
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
- Be taking at least one chronic medication
Key exclusion criteria (4 listed)
- Too ill to complete the experiment
- Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart)
- Inability to communicate in either Spanish or English
- Overt psychiatric illnesses, overt delirium or dementia
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 |
|---|---|---|
| Drug indication iconsIcons illustrate the purpose of each medication | Behavioural | Drug indication icons, Icons + Structured instructions |
| Structured instructionsGraphical format shows what time(s) of day each medication should be taken | Behavioural | Icons + Structured instructions, Structured instructions |
Primary outcome
Understanding of medication instructions
Time frame: Within 10-20 minutes
Participants' ability to state the drug indication
1 secondary outcome
Recall of medication instructions
Time frame: Within 10-20 minutes
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 13 Jun 2012.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug indication icons and Structured instructions in people with Understanding of Medication Instructions and Recall of Medication Instructions, run by PictureRx, LLC at 2 sites 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 4 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 13 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 2 sites 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?
Understanding of medication instructions (time frame: Within 10-20 minutes). 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 13 Jun 2012.