NCT00687869

Brief Summary

Primary objective of this study is to determine whether a case management of stroke patients after discharge to home or to nursing home results in improving physical and cognitive capacity one year after discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
322

participants targeted

Target at P50-P75 for phase_3 stroke

Timeline
Completed

Started Jun 2008

Typical duration for phase_3 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

3.8 years

First QC Date

May 28, 2008

Last Update Submit

September 18, 2013

Conditions

Stroke

Keywords

strokerehabilitationpatient care managementpatient participation

Outcome Measures

Primary Outcomes (1)

  • physical scale of the Stroke Impact Scale 3.0

    before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization

Secondary Outcomes (1)

  • Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND

    before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization

Study Arms (2)

Case management

EXPERIMENTAL

Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal

Behavioral: Case management

usual care

ACTIVE COMPARATOR

Usual stroke aftercare plus patient-information-notes

Behavioral: Case management

Interventions

Case managementBEHAVIORAL

Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal

Case management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding) with signs and symptoms of an acute stroke according to the diagnosis I61 and I63 of the ICD-10-GM 2008
  • Differentiation between ischemic or haemorrhagic stroke by the use of CT or MRT
  • Resident in Saxony-Anhalt or Saxony or Thuringia
  • Able to understand German language

You may not qualify if:

  • Reinfarction
  • Alcoholism
  • Death in acute care
  • NIHHS \> 25
  • Homelessness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)

Halle, Germany

Location

Related Publications (1)

  • Saal S, Becker C, Lorenz S, Schubert M, Kuss O, Stang A, Muller T, Kraft A, Behrens J. Effect of a stroke support service in Germany: a randomized trial. Top Stroke Rehabil. 2015 Dec;22(6):429-36. doi: 10.1179/1074935714Z.0000000047. Epub 2015 Apr 28.

    PMID: 25920942DERIVED

MeSH Terms

Conditions

StrokePatient Participation

Interventions

Case Management

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Johann Behrens, Prof. Dr.

    Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. phil. habil.

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 2, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

DE(1)