Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000165684
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
16/08/2005
Date last updated
8/01/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing prehospital delay in Acute Myocardial Infarction
Scientific title
A randomised control trial to evaluate the effect of a individualised teaching intervention on the response of patientâ¿¿s with coronary heart disease to symptoms of myocardial infarction.
Universal Trial Number (UTN)
Trial acronym
PROMOTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 260 0
Condition category
Condition code
Cardiovascular 292 292 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
54oo patients with documented ischaemic heart disease were randomised to the experimental intervention or to a care-as-usual group at six participating sites. The intervention group received face-to-face counselling about the symptoms of AMI and the importance of seeking treatment early, as well as emergency medical system (EMS) and aspirin use. They also received telephonic reinforcement of the intervention at one month follow-up. Data are collected at baseline, immediately following the intervention, 3, 12 and 24 months. Instruments to be used include teh Response Questionnnaire, Cardiac Control Index, Brief Symptom Inventory Anxiety Subscale and teh Resource Utilisation Interview. Pre-hospital delay, EMS use, aspirin use and resource utilisation are evaluated by means of medical record review and patient interview
Comparator / control treatment
Usual Care
Control group
Uncontrolled

Outcomes
Primary outcome [1] 343 0
1. To compare length of prehospital delay in seeking treatment for AMI signs and symptoms in patients at risk for AMI whom previously received a focused education and counselling intervention with that of a control group who did not receive the intervention.
Timepoint [1] 343 0
Primary outcome [2] 344 0
1a. To determine whether selected demographic variables interact with the intervention to affect length of prehospital delay time.
Timepoint [2] 344 0
Primary outcome [3] 345 0
1b. To determine whether different means of health care payment interact with the intervention to affect the length of prehospital delay time.
Timepoint [3] 345 0
Secondary outcome [1] 779 0
To compare emergency medical system use rate between patients experiencing signs and symptoms of AMI who previously received a focused education and counselling intervention and a control group of those who did not receive the intervention.
Timepoint [1] 779 0
Secondary outcome [2] 780 0
To determine whether selected demographic variables interact with the intervention to affect EMS use rates.
Timepoint [2] 780 0
Secondary outcome [3] 781 0
To determine whether different means of health care payment interact with the intervention to affect EMS use rates. EMS use are collected at the same time as above.
Timepoint [3] 781 0

Eligibility
Key inclusion criteria
1. Have a diagnosis of ischaemic heart disease and 2. live independently.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. a complicating serious co morbidity such as a psychiatric illness 2. untreated malignancy or neurological disorder which impairs cognition, 3. unable to understand spoken English and unable to respond to English language questions in the data collection instrument, 4. a major and uncorrected hearing loss.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
When advised by telephone that the patietn wishes to participate an investigator selected the next numbered opaque envelope containing the group assignment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated assignment of sequential study numbers to intervention (1) or control (0) in blocks per site
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/05/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 351 0
Government body
Name [1] 351 0
National Institute of Health, National Institute of Nursing Research Grant
Country [1] 351 0
United States of America
Primary sponsor type
Individual
Name
Professor Kathleen Dracup, The University of California, San Francisco
Address
Country
United States of America
Secondary sponsor category [1] 276 0
Individual
Name [1] 276 0
Professor Sharon McKinley, The University of Technology, Sydney
Address [1] 276 0
Country [1] 276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1317 0
The University of Technology, Sydney
Ethics committee address [1] 1317 0
Ethics committee country [1] 1317 0
Australia
Date submitted for ethics approval [1] 1317 0
Approval date [1] 1317 0
Ethics approval number [1] 1317 0
Ethics committee name [2] 1318 0
Northern Sydney Area Health Service
Ethics committee address [2] 1318 0
Ethics committee country [2] 1318 0
Australia
Date submitted for ethics approval [2] 1318 0
Approval date [2] 1318 0
Ethics approval number [2] 1318 0
Ethics committee name [3] 1319 0
South Eastern Area Health Service
Ethics committee address [3] 1319 0
Ethics committee country [3] 1319 0
Australia
Date submitted for ethics approval [3] 1319 0
Approval date [3] 1319 0
Ethics approval number [3] 1319 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36366 0
Address 36366 0
Country 36366 0
Phone 36366 0
Fax 36366 0
Email 36366 0
Contact person for public queries
Name 9349 0
Professor Sharon McKinley
Address 9349 0
Critical Care Nursing Professorial Unit
Royal North Shore Hospital
Level 6
St Leonards NSW 2065
Country 9349 0
Australia
Phone 9349 0
+61 2 99268281
Fax 9349 0
+61 2 94398418
Email 9349 0
Sharon.McKinley@uts.edu.au
Contact person for scientific queries
Name 277 0
Professor Sharon McKinley
Address 277 0
Critical Care Nursing Professorial Unit
Royal North Shore Hospital
Level 6
St Leonards NSW 2065
Country 277 0
Australia
Phone 277 0
+61 2 99268281
Fax 277 0
+61 2 94398418
Email 277 0
Sharon.McKinley@uts.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.