Acute Coronary Syndrome (ACS)IMAGE-ACSNCT00399880
Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes
A study testing Health literacy intervention in people with Acute Coronary Syndrome (ACS), run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Coronary heart disease (CHD) is the leading cause of death in the United States. Most people who die from CHD die of a heart attack. Acute coronary syndrome (ACS) is a term that includes mild heart attacks, as well as other episodes of chest pain that may serve as a warning sign for an upcoming heart attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- What is being tested?
- Health literacy intervention
- 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
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Present with acute chest pain or angina equivalent, lasting ≥ 10 minutes of suspected ischemic origin, within the previous 24 hours of presentation to the hospital.
- PLUS
- Patient must have documented objective evidence of myocardial ischemia based on a or b:
- EKG changes in ≥ 2 contiguous leads shown by:
- Transient (< 30 min) ST-segment elevation of ≥ 1.0mm
- OR
Show all 13Show fewer
- Transient or persistent ST-segment depression of ≥ 0.5mm (flat or downsloping at the J-point and at 80ms after the J-point)
- OR
- Persistent T-wave inversion of ≥ 2.0mm
- Abnormal elevation of cardiac enzymes
- Elevation of creating kinase (CK) and creatine kinase-myocardial band (CK-MB)
- OR
- Elevation of troponin
Who cannot join
- Previously enrolled in the study
- Police custody
- Corrected visual acuity worse than 20/60
- Lack of cooperation
- Severe hearing impairment
- Too ill to participate
Show all 15Show fewer
- Unintelligible speech
- Age younger than 18 years
- Native language other than English
- Psychotic illness
- Caregiver administers all medications
- Delirium/severe dementia
- Does not fill prescriptions at Grady
- No regular telephone/address
- Not taking chronic medications prior to admission
Trial locations and contacts
1 site in 1 country.
About this study
Coronary heart disease (CHD) is the leading cause of death in the United States. Most people who die from CHD die of a heart attack. Acute coronary syndrome (ACS) is a term that includes mild heart attacks, as well as other episodes of chest pain that may serve as a warning sign for an upcoming heart attack.
There are many medicines that can help prevent and treat ACS. However, at least 25% of patients don't take their medications as prescribed. When patients don't take their medications, we say they are noncompliant or nonadherent with the treatment.
Read more
The period following hospital discharge is a vulnerable time for many patients. Patients are often confused about what to do when they return home from the hospital. Many patients don't take their medications correctly, or they don't take them at all. Patients with poor literacy skills have more trouble than others, because it is harder for them to follow written instructions. Overall, about half of the adults in the U.S. have poor literacy skills. It is important to develop ways to help these adults manage their health better.
The purposes of this research project are 1) to learn more about the relationship between low literacy and medication adherence after hospital discharge, and 2) to test a strategy designed to help patients take their medicines more regularly. We will recruit consenting patients hospitalized with ACS. We will measure their literacy skills, ask questions about how they take their medicines, and measure other related factors like social support and self-efficacy. Patients will then be assigned to 1 of 2 groups. One group will receive only usual care at hospital discharge, which usually includes the nurse and physician briefly reviewing the medication prescriptions. The other group will receive an illustrated daily medication schedule and special, tailored counseling from a pharmacist at their time of discharge. About 1 week after patients leave the hospital we will contact them by phone to ask them questions about how they have been taking their medicines. We will get data from patients records for 6 months to see if the intervention had an impact on their medication compliance, blood pressure, cholesterol, and diabetes measurements.
If this study is successful, this simple strategy could be implemented by hospitals to improve medication compliance after discharge. This study will also provide more information about how patients' literacy skills affect their medication compliance.
- Conditions
- Acute Coronary Syndrome (ACS)
- Being tested
- Health literacy intervention
- Keywords
- Clinical Trial, Behavioral/Social, Cardiovascular Disease, Risk Factors/Analysis
- Medical subject headings
- Acute Coronary Syndrome, Behavior, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health literacy interventionBehavioural
Illustrated medication schedules, pill boxes, pharmacist counseling
| Study group | Role | What they receive |
|---|---|---|
| Health literacy intervention | Experimental | Illustrated medication schedules, pill boxes, pharmacist counseling Receives: Behavioral: Health literacy intervention |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Refills and Medications Scale (ARMS)
Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.
Measured: Approximately 2 weeks after hospital discharge
Secondary outcomes (1)
Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence.
Measured: Approximately 2 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Society of Health-System Pharmacists Research and Education Foundation
- Responsible party
- Principal investigator, Sunil Kripalani, Vanderbilt University Medical Center
- Investigators
- Sunil Kripalani, MD, MSc, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399880
- Sponsor's protocol ID
- 00000116
- Other IDs
- K23HL077597
- Acronym
- IMAGE-ACS
- Status last verified
- Jul 2017
- First submitted
- 13 Nov 2006
- Last updated
- 25 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT00399880
- Acronym / sponsor ID
- IMAGE-ACS / 00000116
- Conditions
- Acute Coronary Syndrome (ACS)
- Keywords
- Clinical Trial, Behavioral/Social, Cardiovascular Disease, Risk Factors/Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Society of Health-System Pharmacists Research and Education Foundation
- Study start
- Nov 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Nov 2006 (estimated)
- Results
- Posted 25 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary heart disease (CHD) is the leading cause of death in the United States. Most people who die from CHD die of a heart attack. Acute coronary syndrome (ACS) is a term that includes mild heart attacks, as well as other episodes of chest pain that may serve as a warning sign for an upcoming heart attack.
There are many medicines that can help prevent and treat ACS. However, at least 25% of patients don't take their medications as prescribed. When patients don't take their medications, we say they are noncompliant or nonadherent with the treatment.
The period following hospital discharge is a vulnerable time for many patients. Patients are often confused about what to do when they return home from the hospital. Many patients don't take their medications correctly, or they don't take them at all. Patients with poor literacy skills have more trouble than others, because it is harder for them to follow written instructions. Overall, about half of the adults in the U.S. have poor literacy skills. It is important to develop ways to help these adults manage their health better.
The purposes of this research project are 1) to learn more about the relationship between low literacy and medication adherence after hospital discharge, and 2) to test a strategy designed to help patients take their medicines more regularly. We will recruit consenting patients hospitalized with ACS. We will measure their literacy skills, ask questions about how they take their medicines, and measure other related factors like social support and self-efficacy. Patients will then be assigned to 1 of 2 groups. One group will receive only usual care at hospital discharge, which usually includes the nurse and physician briefly reviewing the medication prescriptions. The other group will receive an illustrated daily medication schedule and special, tailored counseling from a pharmacist at their time of discharge. About 1 week after patients leave the hospital we will contact them by phone to ask them questions about how they have been taking their medicines. We will get data from patients records for 6 months to see if the intervention had an impact on their medication compliance, blood pressure, cholesterol, and diabetes measurements.
If this study is successful, this simple strategy could be implemented by hospitals to improve medication compliance after discharge. This study will also provide more information about how patients' literacy skills affect their medication compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health literacy intervention | Experimental | Behavioral: Health literacy interventionIllustrated medication schedules, pill boxes, pharmacist counseling |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Present with acute chest pain or angina equivalent, lasting ≥ 10 minutes of suspected ischemic origin, within the previous 24 hours of presentation to the hospital.
- PLUS
- Patient must have documented objective evidence of myocardial ischemia based on a or b:
- OR
- OR
Key exclusion criteria (15 listed)
- Previously enrolled in the study
- Police custody
- Corrected visual acuity worse than 20/60
- Lack of cooperation
- Severe hearing impairment
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 |
|---|---|---|
| Health literacy interventionIllustrated medication schedules, pill boxes, pharmacist counseling | Behavioural | Health literacy intervention |
Primary outcome
Adherence to Refills and Medications Scale (ARMS)
Time frame: Approximately 2 weeks after hospital discharge
Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.
1 secondary outcome
Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
Time frame: Approximately 2 weeks after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sunil Kripalani, MD, MSc principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health literacy intervention in people with Acute Coronary Syndrome (ACS), run by Vanderbilt University Medical Center 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 13 inclusion and 15 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 25 Sep 2017. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence to Refills and Medications Scale (ARMS) (time frame: Approximately 2 weeks after hospital discharge). 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 25 Sep 2017.