Secondary Prevention and Health Promotion After Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ann-Cathrin Jonsson, Skane University Hospital
ClinicalTrials.gov Identifier:
NCT01466907
First received: November 4, 2011
Last updated: January 22, 2014
Last verified: January 2014

November 4, 2011
January 22, 2014
February 2008
February 2010   (final data collection date for primary outcome measure)
Risk factors and health outcome compared between intervention group and control group [ Time Frame: Baseline to one year after stroke for both groups. ] [ Designated as safety issue: Yes ]
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.
Number of interventions needed [ Time Frame: Number of interventions needed in intervention group vs control group one year after stroke. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01466907 on ClinicalTrials.gov Archive Site
Risk factors and health outcome at two follow-ups. [ Time Frame: Baseline to one year after stroke ] [ Designated as safety issue: Yes ]
Comparison of health outcome at three months and one year after stroke in the intervention group.
Prevalence of depression [ Time Frame: One year after stroke ] [ Designated as safety issue: Yes ]
Measured with the EQ5D protocol.
Not Provided
Not Provided
 
Secondary Prevention and Health Promotion After Stroke
Secondary Prevention and Health Promotion After Stroke A Nurse-led Randomized Controlled Open Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Stroke
  • 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.
  • 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.
  • 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.
    Intervention: Other: Secondary prevention, supportive counselling
  • 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.
    Intervention: Other: Standard care until one year follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
597
April 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

WHO criteria for definition of stroke Signed consent

Exclusion Criteria:

Other diagnosis causing neurological symptoms

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01466907
MaStrokeFup0809, UMASNL
No
Ann-Cathrin Jonsson, Skane University Hospital
Skane University Hospital
Not Provided
Principal Investigator: Ann-Cathrin Jönsson, PhD Department of Health Sciences, Lund University
Skane University Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP