NCT01942031

Brief Summary

Stroke is a devastating disease. The acute mortality in Sweden is 20 % and 25 % of all patients relapse. Secondary prevention is proven efficient but observational studies have shown that a number of patients are lost to follow up and do not receive recommended prevention. The aim of the study is to 1) describe, by analyzing register data, the detection rate of patients with hospital diagnosis of stroke, TIA, and atrial fibrillation in the primary care center where they are listed. The analysis is done by sex, age, and socioeconomic status. Furthermore, rate of dispensed prescriptions of secondary preventive drugs are analysed for the identified population. 2) in a randomized controlled study evaluate if collegial feed back and targeted information of secondary prevention to the intervention group can improve the detection rate and the medication of the patients listed at the participating primary care centers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

5.4 years

First QC Date

April 15, 2013

Last Update Submit

September 14, 2020

Conditions

Keywords

Ischemic strokeHemorrhagic strokeTIAAtrial fibrillationpreventionprimary care

Outcome Measures

Primary Outcomes (1)

  • percentage of identified patients with stroke/TIA in primary care and analysis of dispensed prescriptions in each group

    percentage of patients identified with hospital discharge diagnosis of stroke/TIA in primary care diagnosis register. Analysis of changes in outcome before intervention and after. the intervention will take place during one year and collection of data before start of intervention and one year after ended intervention will be performed

    Outcome meassures will be followed during two years

Secondary Outcomes (1)

  • dispensed prescriptions of secondary preventives drugs in patients with stroke/TIA

    baseline 2010 and 2012, followed for one year after intervention

Study Arms (2)

structured collegial feed back

EXPERIMENTAL

Structured feed back and information about stroke to the primary care center, to physicians and head of the center

Behavioral: structured collegial feed back

Control group

NO INTERVENTION

No structured feed back on stroke prevention. Ordinary educational activities only.

Interventions

Collegial feed back to primary care physicians at randomized primary care centers

structured collegial feed back

Eligibility Criteria

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

You may qualify if:

  • Primary care center in Stockholm county

You may not qualify if:

  • localisation outside Stockholm County

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet Stroke Research Network at Södersjukhuset

Stockholm, Sweden

Location

Related Publications (2)

  • Geary L, Hasselstrom J, Carlsson AC, Eriksson I, von Euler M. Secondary prevention after stroke/transient ischemic attack: A randomized audit and feedback trial. Acta Neurol Scand. 2019 Aug;140(2):107-115. doi: 10.1111/ane.13109. Epub 2019 May 9.

  • Geary L, Hasselstrom J, Carlsson AC, Schenck-Gustafsson K, von Euler M. An audit & feedback intervention for improved anticoagulant use in patients with atrial fibrillation in primary care. Int J Cardiol. 2020 Jul 1;310:67-72. doi: 10.1016/j.ijcard.2020.04.027. Epub 2020 Apr 12. No abstract available.

MeSH Terms

Conditions

Ischemic StrokeHemorrhagic StrokeAtrial Fibrillation

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mia von Euler, MD, PhD

    Karolinska Institutet

    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
Associate Professor, Head Karolinska Institutet Stroke Research Network at Södersjukhuset

Study Record Dates

First Submitted

April 15, 2013

First Posted

September 13, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2019

Study Completion

October 1, 2019

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations