Secondary Prevention and Health Promotion After Stroke

Stroke Clinical Trial

Official title:

Secondary Prevention and Health Promotion After Stroke A Nurse-led Randomized Controlled Open Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466907
• Other study ID #: MaStrokeFup0809
• Secondary ID: UMASNL
• Status: Completed
• Phase: N/A
• First received: November 4, 2011
• Last updated: January 22, 2014
• Start date: February 2008
• Est. completion date: April 2010

Study information

• Verified date: January 2014
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

WHO criteria for definition of stroke Signed consent

Exclusion Criteria:

Other diagnosis causing neurological symptoms

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Standard care until one year follow-up
No intervention three months after stroke. Assessment one year after stroke and comparison with the intervention group.

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors and health outcome compared between intervention group and control group	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.	Baseline to one year after stroke for both groups.	Yes
Secondary	Risk factors and health outcome at two follow-ups.	Comparison of health outcome at three months and one year after stroke in the intervention group.	Baseline to one year after stroke	Yes