Condition category
Circulatory System
Date applied
10/07/2011
Date assigned
24/08/2011
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Myocardial infarction (heart attack) is a common cause of death and disability in Sweden and internationally. There are a number of effective treatments to keep a person healthy after an infarction but the use of these in routine care has not been successful. The aim of this study is to find out whether long-term follow-ups after a myocardial infarction by specially trained nurses improve the use of effective preventive treatments, and improve blood pressure, lipid values, exercise habits and smoking cessation.

Who can participate?
All patients diagnosed with a myocardial infarction over a period of about three years in the county of Jämtland, Sweden, who were treated at the county’s only hospital, Östersund Hospital.

What does the study involve?
You will be randomly allocated to one of two groups: the intervention group or the usual care group. Patients in both groups will provide a blood sample and a blood pressure measurement, and your cardiac symptoms, compliance with medication, tobacco use and physical activity will be recorded. Both groups will be contacted by a study nurse by phone 1 month after discharge. If you are allocated to the intervention group, during the call you will be informed about the test results and if a change in medication is necessary. The study nurse will support smoking cessation, encourage physical activity, and provide dietary advice to reduce saturated fat and increase your intake of fruit and vegetables. If your cholesterol or blood pressure values are high your medication will be adjusted after contact with a study physician. Repeat tests will be taken within about 4 weeks and further adjustments made if necessary. The same routine will be applied after 12, 24 and 36 months. Patients allocated to the usual care group will also be contacted by phone 1 month after discharge. All medical care will be given by their general practitioner who receives the test results and no additional intervention will be given as a result of participation in the study. The same routine will be applied after 12, 24 and 36 months.

What are the possible benefits and risks of participating?
Potentially participants can get a more effective preventive treatment. Only standard medical treatments for hypertension and lipid lowering are used.

Where is the study run from?
Dept. of Public Health and Clinical Medicine Umea University (Sweden)

When is the study starting and how long is it expected to run for?
January 2010 to December 2012

Who is funding the study?
Research and Development Unit at Jamtland County Council (Sweden)

Who is the main contact?
Ass prof Thomas Mooe
thomas.mooe@medicin.umu.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Mooe

ORCID ID

Contact details

Dept. of Public Health and Clinical Medicine Umea University
Hus 10 Plan 5
Östersund
SE-83183
Sweden
-
thomas.mooe@medicin.umu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Secondary preventive, nurse-based, telephone follow-up for risk factor control after an acute coronary syndrome: a randomised, controlled, population-based study

Acronym

NAILED ACS

Study hypothesis

The NAILED ACS risk factor trial (Nurse based, Age independent Intervention to Limit Evolution of Disease after Acute Coronary Syndrome). We hypothesised that this nurse based, telephone follow-up would reduce risk factor levels more effectively than usual care.

Ethics approval

The Regional Ethical Review Board, Umeå University, Umeå, Sweden, 16/12/2009, ref: Dnr 09-142M

Study design

Single-centre randomised controlled trial with two parallel groups

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute coronary syndrome

Intervention

Patients randomised to the intervention group will be contacted by a study nurse by phone 1 month after discharge. Before the call a blood sample for lipids will be taken and a standardised blood pressure control will be performed. Blood pressure will be measured after 5 minutes in the sitting position and after 1 minute standing. The tests will be performed by a district nurse, or, for patients in the intervention group living close to the hospital, by a study nurse. Cardiac symptoms, self reported compliance with medication, tobacco use and physical activity will be recorded. During the call the patient will be informed about the test results and if a change in medication is necessary. Tobacco use, physical activity and dietary habits will be discussed. Smoking cessation will be supported. Physical activity of moderate intensity 30 minutes or more most days of the week will be encouraged but also adjusted to the individual patients capacity. Dietary advice to reduce saturated fat and increase the intake of fruit and vegetables will be given. If the patients cholesterol or blood pressure values are above target medication will by adjusted after contact with a study physician. Repeat tests will be taken within approximately 4 weeks and further adjustments made if necessary until target values are reached or no further changes are reasonable. The same routine will be applied after 12, 24 and 36 months. The target values are: systolic blood pressure <140 / <90 mmHg (optionally <130 / <80 mmHg in patients assessed to be at high risk i.e. diabetics), total cholesterol < 4.5 mmol/l, LDL < 2.5 mmol/l.

Patients randomised to the usual care group will also be contacted by phone 1 month after discharge after blood pressure and lipid profile measurements. Cardiac symptoms, self reported compliance, tobacco use and physical activity will be recorded. All medical care will be given by their general practitioner who receives the test results (lipid profile and blood pressure) and no additional intervention will be given as a result of participation in the study. The same routine will be applied after 12, 24 and 36 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Total cholesterol and low density lipoprotein (LDL) cholesterol
2. Sitting systolic and diastolic blood pressure
An adjusted analysis to account for differences in important baseline variables, if any, will be performed. Outcomes are measured after 12, 24 and 36 months of follow-up.

Secondary outcome measures

1. The proportion of patients reaching the target for:
1.1. Total cholesterol and LDL cholesterol
1.2. Sitting systolic and diastolic blood pressure
1.3. Standing systolic and diastolic blood pressure
1.4. Smoking rates
1.5. Change in body mass index and physical activity
Blood pressures are measured standardised as described above. Smoking (yes/no) and physical activity (duration and intensity/week) are self reported. Subanalyses according to age and gender are planned.

Overall trial start date

01/01/2010

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients living in the county of Jämtland, Sweden, and hospitalised with a diagnosis of myocardial infarction or unstable angina will be assessed for inclusion.
1.1. Östersund hospital is the only hospital in the county and all patients, terminal care excluded, with symptoms of a suspected acute coronary syndrome are referred for diagnostic evaluation. A routine for identification of all patients in the hospital with a possible acute coronary syndrome ( ACS) has been established in previous studies.
2. All patients with a physical and mental capacity to communicate by telephone

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Patients with severe disease
2. Not able to communicate by telephone
3. Dementia
4. Deafness
5. Participation in another trial

Recruitment start date

01/01/2010

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Sweden

Trial participating centre

Dept. of Public Health and Clinical Medicine Umea University
Östersund
SE-83183
Sweden

Sponsor information

Organisation

Jamtland County Council (Sweden)

Sponsor details

The Research and Development Unit
Jamtland County Council
Box 654
Östersund
SE-83127
Sweden
-
jamtlands.lans.landsting@jll.se

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

The Research and Development Unit, Jamtland County Council (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25131960
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26466804
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26876722
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27129980

Publication citations

  1. Protocol

    Mooe T, Björklund F, Graipe A, Huber D, Jakobsson S, Kajermo U, Strömvall A, Ulvenstam A, The Nurse-Based Age Independent Intervention to Limit Evolution of Disease After Acute Coronary Syndrome (NAILED ACS) Risk Factor Trial: Protocol for a Randomized Controlled Trial., JMIR Res Protoc, 2014, 3, 3, e42, doi: 10.2196/resprot.3466.

Additional files

Editorial Notes

05/05/2016: Publication reference added. 17/10/2016: Publication reference added. 16/10/2015: Publication reference added. On 02/03/2015 the overall trial end date was changed from from 31/12/2014 to 31/12/2017. On 12/07/2013 the overall trial end date was changed from 31/12/2012 to 31/12/2014 and the target number of participants was changed from 600 to 800.