Acute Coronary SyndromePROMOTIONNCT00734760
An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome
A study testing education in people with Acute Coronary Syndrome, run by University of California, San Francisco.
Trial summary
This study was conducted to test whether a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as having ischemic heart disease. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,522 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to Jun 2006
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of ischemic heart disease, confirmed by their physician or medical record
- lived independently (i.e., not in an institutional setting).
Who cannot join
- complicating serious co-morbidity such as a psychiatric illness or untreated malignancy
- neurological disorder with impaired cognition
- inability to read or understand English.
- major uncorrected hearing loss
About this study
Official title: Reducing Prehospital Delay in Acute Myocardial Infarction
This study was conducted to test whether a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as having ischemic heart disease.
Read the detailed description
Delay to treatment from the onset acute coronary syndrome (ACS)continues to be a significant cause of morbidity and mortality. This study was conducted to evaluate a tailored education and counseling program designed for individuals at high risk for a future event. Study Hypothesis: The central hypothesis of this study was that a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of AMI in patients already identified as having ischemic heart disease. Patients were randomized to receive a nurse-administered education and counseling intervention designed to promote early presentation for medical treatment in the face of cardiac symptoms or to usual instructions by their healthcare provider. Primary \& Secondary Endpoints: The primary endpoint of this trial was prehospital delay time, i.e., time from onset of symptoms to arrival at the hospital. The secondary endpoints were: use of the emergency medical system; use of aspirin; healthcare resource utilization; and knowledge, attitudes and beliefs about heart disease.
- Conditions
- Acute Coronary Syndrome
- Being tested
- education
- Keywords
- patient education, acute coronary syndrome, prehospital delay to treatment
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
Also called none applicable
face-to-face education and counseling intervention
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | a tailored, face-to-face education and counseling intervention with a nurse lasting approximately 45 minutes, followed by a telephonic reinforcement in 30 days Receives: Behavioral: education |
| B | No intervention | care-as-usual with data collection at the same time points as the experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
time from ACS symptom onset to admission to emergency department
Measured: two years
Secondary outcomes (3)
pre-hospital aspirin use
Measured: two years
emergency medical system use
Measured: two years
resource utilization
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startFeb 2001
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,522 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Kathleen A Dracup, DNSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734760
- Sponsor's protocol ID
- RO! NR05323
- Other IDs
- NIH RO! NR05323
- Acronym
- PROMOTION
- Status last verified
- Aug 2008
- First submitted
- 12 Aug 2008
- Last updated
- 14 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dracup K, McKinley S, Doering LV, Riegel B, Meischke H, Moser DK, Pelter M, Carlson B, Aitken L, Marshall A, Cross R, Paul SM. Acute coronary syndrome: what do patients know? Arch Intern Med. 2008 May 26;168(10):1049-54. doi: 10.1001/archinte.168.10.1049.
PubMed 18504332Aitken LM, Pelter MM, Carlson B, Marshall AP, Cross R, McKinley S, Dracup K. Effective strategies for implementing a multicenter international clinical trial. J Nurs Scholarsh. 2008;40(2):101-8. doi: 10.1111/j.1547-5069.2008.00213.x.
PubMed 18507563Riegel B, McKinley S, Moser DK, Meischke H, Doering L, Dracup K. Psychometric evaluation of the Acute Coronary Syndrome (ACS) Response Index. Res Nurs Health. 2007 Dec;30(6):584-94. doi: 10.1002/nur.20213.
PubMed 18022812Dracup K, McKinley S, Riegel B, Mieschke H, Doering LV, Moser DK. A nursing intervention to reduce prehospital delay in acute coronary syndrome: a randomized clinical trial. J Cardiovasc Nurs. 2006 May-Jun;21(3):186-93. doi: 10.1097/00005082-200605000-00006.
PubMed 16699358Dracup K, McKinley S, Riegel B, Moser DK, Meischke H, Doering LV, Davidson P, Paul SM, Baker H, Pelter M. A randomized clinical trial to reduce patient prehospital delay to treatment in acute coronary syndrome. Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):524-32. doi: 10.1161/CIRCOUTCOMES.109.852608. Epub 2009 Oct 6.
PubMed 20031889
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Prehospital Delay in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00734760
- Acronym / sponsor ID
- PROMOTION / RO! NR05323
- Conditions
- Acute Coronary Syndrome
- Keywords
- patient education, acute coronary syndrome, prehospital delay to treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,522 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2001
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 14 Aug 2008 (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 study was conducted to test whether a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as having ischemic heart disease.
Detailed description
Delay to treatment from the onset acute coronary syndrome (ACS)continues to be a significant cause of morbidity and mortality. This study was conducted to evaluate a tailored education and counseling program designed for individuals at high risk for a future event. Study Hypothesis: The central hypothesis of this study was that a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of AMI in patients already identified as having ischemic heart disease. Patients were randomized to receive a nurse-administered education and counseling intervention designed to promote early presentation for medical treatment in the face of cardiac symptoms or to usual instructions by their healthcare provider. Primary \& Secondary Endpoints: The primary endpoint of this trial was prehospital delay time, i.e., time from onset of symptoms to arrival at the hospital. The secondary endpoints were: use of the emergency medical system; use of aspirin; healthcare resource utilization; and knowledge, attitudes and beliefs about heart disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: educationa tailored, face-to-face education and counseling intervention with a nurse lasting approximately 45 minutes, followed by a telephonic reinforcement in 30 days |
| B | No intervention | –care-as-usual with data collection at the same time points as the experimental group |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a diagnosis of ischemic heart disease, confirmed by their physician or medical record
- lived independently (i.e., not in an institutional setting).
Key exclusion criteria (4 listed)
- complicating serious co-morbidity such as a psychiatric illness or untreated malignancy
- neurological disorder with impaired cognition
- inability to read or understand English.
- major uncorrected hearing loss
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 |
|---|---|---|
| educationAlso: none applicableface-to-face education and counseling intervention | Behavioural | A |
Primary outcome
time from ACS symptom onset to admission to emergency department
Time frame: two years
3 secondary outcomes
pre-hospital aspirin use
Time frame: two years
emergency medical system use
Time frame: two years
resource utilization
Time frame: two years
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 14 Aug 2008.
- Background: PubMed 18504332Dracup K, McKinley S, Doering LV, Riegel B, Meischke H, Moser DK, Pelter M, Carlson B, Aitken L, Marshall A, Cross R, Paul SM. Acute coronary syndrome: what do patients know? Arch Intern Med. 2008 May 26;168(10):1049-54. doi: 10.1001/archinte.168.10.1049.
- Background: PubMed 18507563Aitken LM, Pelter MM, Carlson B, Marshall AP, Cross R, McKinley S, Dracup K. Effective strategies for implementing a multicenter international clinical trial. J Nurs Scholarsh. 2008;40(2):101-8. doi: 10.1111/j.1547-5069.2008.00213.x.
- Background: PubMed 18022812Riegel B, McKinley S, Moser DK, Meischke H, Doering L, Dracup K. Psychometric evaluation of the Acute Coronary Syndrome (ACS) Response Index. Res Nurs Health. 2007 Dec;30(6):584-94. doi: 10.1002/nur.20213.
- Background: PubMed 16699358Dracup K, McKinley S, Riegel B, Mieschke H, Doering LV, Moser DK. A nursing intervention to reduce prehospital delay in acute coronary syndrome: a randomized clinical trial. J Cardiovasc Nurs. 2006 May-Jun;21(3):186-93. doi: 10.1097/00005082-200605000-00006.
- Derived from this study: PubMed 20031889Dracup K, McKinley S, Riegel B, Moser DK, Meischke H, Doering LV, Davidson P, Paul SM, Baker H, Pelter M. A randomized clinical trial to reduce patient prehospital delay to treatment in acute coronary syndrome. Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):524-32. doi: 10.1161/CIRCOUTCOMES.109.852608. Epub 2009 Oct 6.
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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.
Kathleen A Dracup, DNSc principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Acute Coronary Syndrome, run by University of California, San Francisco.
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 2 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 14 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
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 from ACS symptom onset to admission to emergency department (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00734760, which also lists 5 linked publications.
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 14 Aug 2008.