Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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. ] [ 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.


Secondary Outcome Measures:
  • 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.


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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ann-Cathrin Jonsson, Ass. Professor, Skane University Hospital
ClinicalTrials.gov Identifier: NCT01466907     History of Changes
Other Study ID Numbers: MaStrokeFup0809, UMASNL
Study First Received: November 4, 2011
Last Updated: January 22, 2014
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014