Medication AdherenceNCT01618409
PictureRx: An Intervention to Reduce Latino Health Disparities
A study testing PictureRx card in people with Medication Adherence and Diabetes, run by PictureRx, LLC at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to evaluate the effect of Spanish-language illustrated medication instructions (PictureRx cards), compared to traditional medication instructions, on Latinos' understanding of their medication regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Diabetes
- What is being tested?
- PictureRx card
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 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
- Diabetes
- Latino, Spanish speaker
- Be at least 18 years old
- Must be taking at least 1 chronic medication
Who cannot join
- 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)
- 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
Saint Thomas Family Health Center - South
Nashville, Tennessee, 37211
About this study
The purpose of this randomized controlled trial is to evaluate the effect of Spanish-language illustrated medication instructions (PictureRx cards), compared to traditional medication instructions, on Latinos' understanding of their medication regimens. The study will also assess the effect on self-reported medication adherence. Patients with diabetes who attend participating clinics are eligible. The target sample size is 200.
- Conditions
- Medication Adherence, Diabetes
- Being tested
- PictureRx card
- Keywords
- PictureRx, Health Literacy, Limited English Proficiency, Latinos, Spanish
- Medical subject headings
- Medication Adherence, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PictureRx cardBehavioural
An illustrated format of medication instructions that includes pictures of the medications and icons to illustrate their purpose
| Study group | Role | What they receive |
|---|---|---|
| PictureRx cards | Experimental | Illustrated format of medication instructions that includes pictures of pills and icons to show their purpose Receives: Behavioral: PictureRx card |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Understanding of their Medication Regimen
The primary outcome will be patients' understanding of their medication regimen, as assessed by an interviewer-administered questionnaire.
Measured: Approximately 1 week after enrollment
Secondary outcomes (1)
Self-reported Adherence
As a secondary outcome, patients will report their self-reported adherence using a validated instrument.
Measured: Approximately 1 week after enrollment
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 startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies 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
- 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
- NCT01618409
- Sponsor's protocol ID
- 1R43MD004048
- Other IDs
- 5R43MD004048-02
- 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
- ClinicalTrials.gov ID
- NCT01618409
- Acronym / sponsor ID
- 1R43MD004048
- Conditions
- Medication Adherence, Diabetes
- Keywords
- PictureRx, Health Literacy, Limited English Proficiency, Latinos, Spanish
- 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
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 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.
The purpose of this randomized controlled trial is to evaluate the effect of Spanish-language illustrated medication instructions (PictureRx cards), compared to traditional medication instructions, on Latinos' understanding of their medication regimens. The study will also assess the effect on self-reported medication adherence. Patients with diabetes who attend participating clinics are eligible. The target sample size is 200.
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 |
|---|---|---|
| PictureRx cards | Experimental | Behavioral: PictureRx cardIllustrated format of medication instructions that includes pictures of pills and icons to show their purpose |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes
- Latino, Spanish speaker
- Be at least 18 years old
- Must be taking at least 1 chronic medication
Key exclusion criteria (5 listed)
- 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)
- 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 |
|---|---|---|
| PictureRx cardAn illustrated format of medication instructions that includes pictures of the medications and icons to illustrate their purpose | Behavioural | PictureRx cards |
Primary outcome
Patient Understanding of their Medication Regimen
Time frame: Approximately 1 week after enrollment
The primary outcome will be patients' understanding of their medication regimen, as assessed by an interviewer-administered questionnaire.
1 secondary outcome
Self-reported Adherence
Time frame: Approximately 1 week after enrollment
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.
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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 card in people with Medication Adherence and Diabetes, 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 5 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 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 1 week after enrollment). 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.