Condition category
Circulatory System
Date applied
13/05/2012
Date assigned
19/06/2012
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
Stroke 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 a stroke. Low blood pressure, low blood lipids, regular physical exercise and smoking cessation can improve health after a stroke. The use of these treatments in routine care has not been successful. Our aim is to study if long-term follow-ups after stroke by specially trained nurses improve the use of the effective treatments mentioned above.

Who can participate?
The participants will be patients diagnosed with a stroke, regardless of age and gender. All patients diagnosed with a stroke in the county of Jamtland during the study period will be assessed for inclusion. The included patients must be able to participate in telephone interviews.

What does the study involve?
The participants will be randomly divided into two groups. One group will be followed up by specially trained nurses. The other group will receive the standard follow-ups in primary healthcare. We will compare the two groups to find out whether the nurse-led follow-ups improve blood pressure, lipid values, exercise habits and smoking cessation.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to the participants, neither will there be any specific risks. The treatment they will receive is the recommended standard treatment after stroke.

Where is the study run from?
The study is run from Östersund Hospital. Östersund Hospital is the only hospital in the county of Jämtland, Sweden. All patients will be recruited from the county of Jämtland.

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

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

Who is the main contact?
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 stroke or transient ischemic attack: a randomised, controlled, population-based study

Acronym

NAILED Stroke

Study hypothesis

The NAILED Stroke risk factor trial (Nurse-based, Age-independent Intervention to Limit Evolution of Disease after Stroke). 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

Home

Trial type

Treatment

Patient information sheet

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

Condition

Stroke

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. 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 patient's 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, 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, low density lipoprotein (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. 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 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

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients living in the county of Jämtland, Sweden, and hospitalised with a diagnosis of 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 a suspected stroke or TIA are referred for diagnostic evaluation. A routine for identification of all patients in the hospital with a possible stroke 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

1000

Participant exclusion criteria

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

Recruitment start date

01/01/2010

Recruitment end date

31/12/2013

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
+46 (0)63 153000
jamtlands.lans.landsting@jll.se

Sponsor type

Government

Website

Funders

Funder type

Government

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

2013 protocol in: www.ncbi.nlm.nih.gov/pubmed/23289919
2015 results in: www.ncbi.nlm.nih.gov/pubmed/26466804
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27129980

Publication citations

  1. Protocol

    Mooe T, Bergström L, Irewall AL, Ogren J, The NAILED stroke risk factor trial (nurse based age independent intervention to limit evolution of disease after stroke): study protocol for a randomized controlled trial., Trials, 2013, 14, 5, doi: 10.1186/1745-6215-14-5.

Additional files

Editorial Notes

05/05/2016: Publication reference added. 16/10/2015: Publication reference added. 02/03/2015: the following changes were made to the trial record: 1. The public title was changed from 'Secondary preventive, nurse-based, telephone follow-up for risk factor control after stroke' to 'Secondary preventive, nurse-based, telephone follow-up for risk factor control after stroke or transient ischemic attack'. 2. The scientific title was changed from 'Secondary preventive, nurse-based, telephone follow-up for risk factor control after stroke: a randomised, controlled, population-based study' to 'Secondary preventive, nurse-based, telephone follow-up for risk factor control after stroke or transient ischemic attack: a randomised, controlled, population-based study'. 3. The overall trial end date was changed from 31/12/2012 to 31/12/2016. 4. The target number of participants was changed from 600 to 1000.