NCT01466907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
597

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

November 4, 2011

Last Update Submit

January 22, 2014

Conditions

Keywords

complicationdepressionfollow-upinterventionnurse-ledoutcomesecondary preventionstroke

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Risk factors and health outcome at two follow-ups.

    Baseline to one year after stroke

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control group

OTHER

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

Interventions

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 group

No intervention three months after stroke. Assessment one year after stroke and comparison with the intervention group.

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • WHO criteria for definition of stroke Signed consent

You may not qualify if:

  • Other diagnosis causing neurological symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Malmo, 205 02, Sweden

Location

MeSH Terms

Conditions

StrokeDepression

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Ann-Cathrin Jönsson, PhD

    Department of Health Sciences, Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Professor

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 8, 2011

Study Start

February 1, 2008

Primary Completion

February 1, 2010

Study Completion

April 1, 2010

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations