Secondary preventive, nurse based, telephone follow-up for reduction of cardiovascular events after acute coronary syndrome or stroke

• Register: ISRCTN
• Last refreshed on: 20 February 2023
• Main ID: ISRCTN30433343
• Date of registration: 26/01/2015
• Prospective Registration: No
• Primary sponsor: Jamtland County Council (Sweden)
• Public title: Secondary preventive, nurse based, telephone follow-up for reduction of cardiovascular events after acute coronary syndrome or stroke
• Scientific title: Secondary preventive, nurse based, telephone follow-up for reduction of cardiovascular events after acute coronary syndrome or stroke: a randomised, controlled, population based study
• Date of first enrolment: 01/01/2010
• Target sample size: 1900
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN30433343
• Study type: Interventional
• Study design: Single-centre randomised open controlled trial with two parallel groups (Prevention)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Thomas Mooe

Key inclusion & exclusion criteria

Inclusion criteria:
1. All patients living in the county of Jämtland, Sweden, and hospitalised with a diagnosis of an acute coronary syndrome (ACS, acute myocardial infarction or unstable angina pectoris), stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) 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 an ACS or suspected stroke or TIA are referred for diagnostic evaluation. A routine for identification of all patients in the hospital with a possible ACS or stroke/TIA has been established in previous studies.
2. All patients with a physical and mental capacity to communicate by telephone

Exclusion criteria:
1. Patients with severe disease
2. Aphasia
3. Dementia
4. Deafness
5. Participation in another trial


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Acute coronary syndrome, stroke and transient ischemic attack
Circulatory System

Intervention(s)

A study nurse will contact patients randomised to the intervention group 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. 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 be 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 months and thereafter early. The target values are: blood pressure <140 / <90 mmHg (optionally <140 / <85 mmHg in diabetic patients), total cholesterol < 4.5 mmol/l, and low density lipoprotein (LDL) < 2.5 mmol/l (<1.8 in diabetic subjects) to comply with local guidelines.

Patients randomised to the usual care group will also be contacted by phone 1 month after discharge after blood

Primary Outcome(s)

Major adverse cardiovascular events identified at the end of trial by reviewing patients medical records and by the Swedish National Patient Register and the Swedish Cause of Death Register defined as:
1. Non-fatal major coronary event: myocardial infarction or coronary revascularisation
2. Non-fatal stroke
3. Cardiovascular death

Secondary Outcome(s)

Major adverse cardiovascular events identified at the end of trial by reviewing patients medical records and by the Swedish National Patient Register and the Swedish Cause of Death Register.
1. Separate assessment of the individual components of the primary endpoint
2. Transient ischemic attack
3. All-cause mortality
4. Separate assessment of the acute coronary syndrome and the stroke / TIA cohorts

Secondary ID(s)

N/A

Source(s) of Monetary Support

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

Ethics review

Status:
Approval date:
Contact:

The Regional Ethical Review Board, Umeå University, Umeå, Sweden approved on 16/12/2009, ref: Dnr 09-142M, and 10/06/2013, ref: Dnr 13-204-32M

Results

• Results available: Yes
• Date Completed: 06/04/2020