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Secondary Prevention and Health Promotion After Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01466907
First Posted: November 8, 2011
Last Update Posted: January 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ann-Cathrin Jonsson, Skane University Hospital
  Purpose
The aim of this study was to examine to what extent a one year population of stroke patients at a university hospital had well regulated risk factors and health problems one year after stroke, and if a structured nurse-led previous follow-up in the intervention group including referrals if needed could influence health outcome and risk factors one year after stroke.

Condition Intervention
Stroke Other: Secondary prevention, supportive counselling Other: Standard care until one year follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Secondary Prevention and Health Promotion After Stroke A Nurse-led Randomized Controlled Open Trial

Further study details as provided by Ann-Cathrin Jonsson, Skane University Hospital:

Primary Outcome Measures:
  • Risk factors and health outcome compared between intervention group and control group [ Time Frame: Baseline to one year after stroke for both groups. ]
    Outcome for both groups after one year was measured as the proportion of risk factors sufficiently treated, the patients' self-reports on health outcome and comparison between the intervention group and the control group.


Secondary Outcome Measures:
  • Risk factors and health outcome at two follow-ups. [ Time Frame: Baseline to one year after stroke ]
    Comparison of health outcome at three months and one year after stroke in the intervention group.


Enrollment: 597
Study Start Date: February 2008
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention group
Control of secondary prevention at three months and one year after stroke and referral to physician if medical interventions are needed. Assessment of functional status and self-reports on health outcome. Supportive counselling provided.
Other: Secondary prevention, supportive counselling
Patients' self-reports on Mobility, Self Care, Usual activities, Pain/Discomfort, Anxiety/Depression, Health Outcome were registered. Health problems were assessed. Secondary prevention was controlled by measuring blood pressure, Cholesterol levels, HbA1c, Weight to estimate nutritional status. Functional status was assessed. Supportive counselling was provided. Referral was sent to physician if medical interventions were needed.
Control group
Standard care with no outlined follow-up until one year after stroke. Control of secondary prevention after one year after stroke and referral to physician if medical interventions are needed. Follow-up one year after stroke according to the same protocol as the intervention group.
Other: Standard care until one year follow-up
No intervention three months after stroke. Assessment one year after stroke and comparison with the intervention group.

Detailed Description:
The follow-up protocol was categorized into Risk factors, Patients' self-reports, and Other health problems. Referral was sent to a physician if medical interventions were needed regarding risk factors measured above the limits as stated in the follow-up protocol in accordance with guidelines,and/or if any self-reported health problems were stated by the patients, or had been detected by the Specialist Nurse. Primary outcome was comparison between the intervention group and control group at one year after stroke regarding proportion of regulated risk factors, and self-reports on health outcome. Results of the two follow-ups of the intervention group were also compared.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

WHO criteria for definition of stroke Signed consent

Exclusion Criteria:

Other diagnosis causing neurological symptoms

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466907


Locations
Sweden
Skåne University Hospital
Malmö, Sweden, 205 02
Sponsors and Collaborators
Skane University Hospital
Investigators
Principal Investigator: Ann-Cathrin Jönsson, PhD Department of Health Sciences, Lund University
  More Information

Responsible Party: Ann-Cathrin Jonsson, Ass. Professor, Skane University Hospital
ClinicalTrials.gov Identifier: NCT01466907     History of Changes
Other Study ID Numbers: MaStrokeFup0809
UMASNL ( Other Identifier: Regional Ethical Review Board DNr 520/2007 )
First Submitted: November 4, 2011
First Posted: November 8, 2011
Last Update Posted: January 23, 2014
Last Verified: January 2014

Keywords provided by Ann-Cathrin Jonsson, Skane University Hospital:
complication
depression
follow-up
intervention
nurse-led
outcome
secondary prevention
stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases