NCT02320994

Brief Summary

In this first step of the study the investigators will assess the needs, disease burden and current treatments of long-term stroke patients (phase MAS-I). The ultimate aim of the complete MAS project (MAS I, II \& III) is the development of a model of stroke aftercare delivery that can be evaluated to estimate effects in both our local and the wider stroke population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

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

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

1.1 years

First QC Date

December 16, 2014

Last Update Submit

December 15, 2021

Conditions

Keywords

strokeaftercare

Outcome Measures

Primary Outcomes (1)

  • Prevalence of unmet Needs

    Unmet needs of patients and carers after discharge from Rehabilitation. Score of variables examined (self-reported stroke related need, post-stroke spasticity, post-stroke pain, post-stroke aphasia, neuropsychological impairment, post-stroke depression, post-stroke dementia, inadequate secondary prevention, social care need and carer burden).

    once

Secondary Outcomes (2)

  • post-stroke checklist

    once

  • Standard practice evaluation

    once

Study Arms (1)

stroke patients

post-rehabilitation stroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in long term course after a moderate to severe ischemic stroke

You may qualify if:

  • Age ≥18 years
  • Participation in one of the previously conducted stroke cohort studies: STRAWINSKI or PREDICT
  • Modified Rankin Score (mRS) recorded as = 1 - 5 (at last follow up during cohort study)
  • Informed consent signed by patient or legal representative

You may not qualify if:

  • Unwilling to have pseudonymised data stored, analyzed \& anonymously published.
  • Patients participating in the previous studies recruited in centres outside Berlin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center)

Berlin, 10117, Germany

Location

Related Publications (3)

  • Hotter B, Padberg I, Liebenau A, Knispel P, Heel S, Steube D, Wissel J, Wellwood I, Meisel A. Identifying unmet needs in long-term stroke care using in-depth assessment and the Post-Stroke Checklist - The Managing Aftercare for Stroke (MAS-I) study. Eur Stroke J. 2018 Sep;3(3):237-245. doi: 10.1177/2396987318771174. Epub 2018 Apr 19.

  • Lehnerer S, Hotter B, Padberg I, Knispel P, Remstedt D, Liebenau A, Grittner U, Wellwood I, Meisel A; BSA Long Term Care Study Group. Social work support and unmet social needs in life after stroke: a cross-sectional exploratory study. BMC Neurol. 2019 Sep 6;19(1):220. doi: 10.1186/s12883-019-1451-y.

  • Padberg I, Hotter B, Liebenau A, Knispel P, Lehnerer S, Heel S, Wellwood I, Meisel A. Unmet Need for Social and Emotional Support and Lack of Recalled Screening Is Associated with Depression in the Long-Term Course After Stroke. Risk Manag Healthc Policy. 2020 Apr 1;13:285-293. doi: 10.2147/RMHP.S228265. eCollection 2020.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andreas Meisel, Prof. Dr. med.

    Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center & Center for Stroke Research Berlin

    PRINCIPAL INVESTIGATOR
  • Ian Wellwood, Prof. Dr.

    Charité - Universitätsmedizin Berlin, Center for Stroke Research Berlin (CSB)

    PRINCIPAL INVESTIGATOR
  • Jörg Wissel, Prof. Dr.

    Neurologie und Psychosomatik am Wittenbergplatz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 4, 2022

Record last verified: 2021-12

Locations