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Secondary Prevention and Health Promotion After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Secondary prevention, supportive counselling
Standard care until one year follow-up
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring complication, depression, follow-up, intervention, nurse-led, outcome, secondary prevention, stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

WHO criteria for definition of stroke Signed consent

Exclusion Criteria:

Other diagnosis causing neurological symptoms

Sites / Locations

  • Skåne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 4, 2011
Last Updated
January 22, 2014
Sponsor
Skane University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01466907
Brief Title
Secondary Prevention and Health Promotion After Stroke
Official Title
Secondary Prevention and Health Promotion After Stroke A Nurse-led Randomized Controlled Open Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skane University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
complication, depression, follow-up, intervention, nurse-led, outcome, secondary prevention, stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
597 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Secondary prevention, supportive counselling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care until one year follow-up
Intervention Description
No intervention three months after stroke. Assessment one year after stroke and comparison with the intervention group.
Primary Outcome Measure Information:
Title
Risk factors and health outcome compared between intervention group and control group
Description
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.
Time Frame
Baseline to one year after stroke for both groups.
Secondary Outcome Measure Information:
Title
Risk factors and health outcome at two follow-ups.
Description
Comparison of health outcome at three months and one year after stroke in the intervention group.
Time Frame
Baseline to one year after stroke

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: WHO criteria for definition of stroke Signed consent Exclusion Criteria: Other diagnosis causing neurological symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Cathrin Jönsson, PhD
Organizational Affiliation
Department of Health Sciences, Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University Hospital
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden

12. IPD Sharing Statement

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Secondary Prevention and Health Promotion After Stroke

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