NCT03097146

Brief Summary

After discharge from hospital, the current healthcare system in Germany allows considerable flexibility (therefore complexity) of patient access and mobility between multiple care providers in the community setting. The investigators believe this aftercare could be better coordinated by a specialized coordinated stroke aftercare service. Comprehensive coordinated multidisciplinary care is a proven concept with proven benefits in both acute and rehabilitation care provided in stroke units and neurorehabilitation centres. In this study, the investigators postulate that a similar coordinated approach to care can be extended to the phase after in-patient rehabilitation has ended (i.e. "long-term management" as opposed to "early supported discharge") for disabled patients with stroke living in the community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Apr 2017

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

April 11, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

3.7 years

First QC Date

March 27, 2017

Last Update Submit

March 24, 2022

Conditions

Stroke

Keywords

StrokeAftercareComprehensive Care

Outcome Measures

Primary Outcomes (1)

  • "EuroQol five dimensions questionnaire" (EuroQoL-5D)

    questionnaire for self-completion by patients for use as a measure of health outcome

    12 Months

Secondary Outcomes (13)

  • Post Stroke Checklist (PSC)

    12 Months

  • modified Rankin Scale (mRS)

    12 Months

  • Barthel-Index (BI)

    12 Months

  • modified Ashworth Scale (mAS)

    12 Months

  • Pain Detect (PD-Q)

    12 Months

  • +8 more secondary outcomes

Study Arms (1)

comprehensive multidisciplinary stroke care

OTHER
Other: comprehensive multidisciplinary stroke care

Interventions

comprehensive multidisciplinary stroke careOTHER

Patients will be treated in the pathological domain. Some of this treatment will be applied by the outpatient clinic itself (i.e. changes in medical secondary prevention or additional prescriptions, social work interventions), whereas most of it will be referred to other providers, if possible in vicinity to the patients' home. In order to ease treatment prescriptions and allow to measure treatment uptake, patients will also enrol in the case management system "Ambulanzpartner". This allows the outpatient center to streamline prescription processes and measure uptake of therapies.

comprehensive multidisciplinary stroke care

Eligibility Criteria

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

You may qualify if:

  • Patients with ischemic stroke
  • Age ≥18 years
  • At the time of V1 completion of rehabilitation or no rehabilitation planned
  • Informed consent signed by patient or legal representative
  • stroke patients with a stratified mRS score
  • within six months after the index event

You may not qualify if:

  • Unwillingness to participate in "AmbulanzPartner"
  • Unwilling to have pseudonymized data stored, analysed, and anonymously published
  • Patients being committed to psychiatric institutions or prisons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NeuroCure Clinical Research Center (NCRC), Charité

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andreas Meisel, Prof. Dr. med.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

March 27, 2017

First Posted

March 31, 2017

Study Start

April 11, 2017

Primary Completion

December 22, 2020

Study Completion

March 1, 2021

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations

DE(1)