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StrokeStroCareNCT04159324

StroCare - Optimised Cross-sectoral,Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement

A study testing optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Trial is a multi-centred controlled interventional study with a pre-post design. The primary aim of the study is the evaluation of the effectiveness and cost-effectiveness of the StroCare treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
409 participants
Where
1 siteGermany
Study dates
1 Jan 2020to 5 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients in inpatient care in the stroke unit of one of the participating acute clinics who are insured at the BARMER health insurance agency with the following diagnosis (ICD-10):
  • Ischemic attack (I63)
  • Transient ischemic attack and related syndromes (G45)
  • Intracerebral haermorrhage (I64)
  • Written informed consent
  • Sufficient mastery of German language

Who cannot join

  • Substantially impaired communication capacity due to aphasia or dementia
  • Patients with artificial Respiration
  • Insufficient adherence
  • Premorbid score of mRS≥4
  • Patients with artificial Respiration (Z99.1)
  • Dementia (F00.x., F01.x. or G30.x) or aphasia (R47)
  • Death during inpatient Treatment or the Admission to a nursing home following the acute treatment

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

Official title: StroCare - Optimised Cross-sectoral, Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement

The Trial is a multi-centred controlled interventional study with a pre-post design. The primary aim of the study is the evaluation of the effectiveness and cost-effectiveness of the StroCare treatment.

Read the detailed description

Stroke is the second most common cause of death in Germany and the most common cause for life-long disability in adulthood. After stroke, patients often experience incisive changes in their health, daily routine and quality of life. The developed model of care (StroCare treatment) forms a cross--sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation. It aims to optimize the transition from acute inpatient treatment after an acute stroke to the ambulant neurological rehabilitation treatment. This is done firstly by creating an electronic portal solution for a safe and coordinated transmission of clinical data between the three participating hospitals and five stroke-specialized ambulant rehabilitation clinics and secondly by introducing a case-manager provided by the participating health insurance agency for patient support and aftercare coordination. The presented study is a multi-centred controlled interventional study with a pre-post design. Stroke patients in both groups are assessed after the index ischemic event and 12 months thereafter. Further sources of information are the medical record, the electronic portal (only intervention group), and routine data provided by the collaborating BARMER health insurance agency (for the Intervention and control group and additionally for a historic control). The main hypotheses are : (1) The StroCare treatment is more effective than the routine aftercare treatment (primary outcome: patient-reported physical quality of life) and (2) the StroCare treatment reduces costs for care and in the inpatient sector by providing more coordinated and thorough rehabilitation and outpatient aftercare.

Conditions
Stroke
Being tested
optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation
Keywords
Stroke, Patient-reported outcomes (PROs), Cross-sectoral care, Stroke aftercare, Aftercare coordination, Post-rehabilitation support, Evidence based treatment, Patient-centred care, Quality of life, Morbidity, Mortality, Functional status, Feasibility, Acceptance, Process evaluation, Health economics
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluationOther

    the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions

Study groups in NCT04159324
Study groupRoleWhat they receive
StroCare treatment groupExperimentalOptimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation
Receives: Other: optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation
control groupNo interventionroutine aftercare stroke treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-reported physical QoL: PROMIS-10

    Patient-reported physical Quality of Life measured with Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10); one of two provided global scores: Global Physcial Health with scores ranging from 0-20 and higher scores indicating better health state.

    Measured: 1 year after index ischemic event

Secondary outcomes (11)

  1. Patient-reported mental QoL

    Patient-reported mental Quality of Life measured with Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10); one of two provided global scores: Global Mental Health with scores ranging from 0-20 and higher scores indicating better health state.

    Measured: 1 year after index ischemic event

  2. Patient-reported mental health status

    Patient reported mental health Status measured with the Patient health questionnaire (PHQ-4); the questionnaire provides two sub-scores measuring anxiety and depression with scores ranging from 0-6 each with higher scores indiciating more symptoms of anxiety or depression, respectively

    Measured: 1 year after index ischemic event

  3. Functional Status modified Rankin Scale questionnaire (smRSq)

    Functional Status measured with the modified Rankin Scale (mRS); the nRS ranges from 0 (no disability) to 6 (death)

    Measured: 1 year after index ischemic event

  4. Overall survival

    Overall survival measured with the ICHOM Standard set

    Measured: 1 year after index ischemic event

  5. Stroke recurrence

    Stroke recurrence measured with the ICHOM Standard set

    Measured: 1 year after index ischemic event

  6. Utilisation of health care Services

    Utilisation of health care Services extracted from the medical record and the electronic Portal (only Intervention Group), i.e., number of admissions to hospital, number of outpatient contacts, weekly hours of physiotherapy, speech therapy, occupational therapy

    Measured: 1 year after index ischemic event

  7. Patient' s waiting time between Treatment phases (Transition) to the ambulant neurological Rehabilitation Treatment)

    Waiting time extracted from the medical record and the electronic Portal (only Intervention Group)

    Measured: 1 year after index ischemic event

  8. Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): blood pressure

    Current values Blood Pressure will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation

    Measured: 1 year after index ischemic event

  9. Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): LDL-cholesterol

    Current values of LDL-cholesterol will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation

    Measured: 1 year after index ischemic event

  10. Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): HbA1c

    Current values of HbA1c will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation

    Measured: 1 year after index ischemic event

  11. Costs

    Routine data

    Measured: 1 year after index ischemic event

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2019
  2. Study start1 Jan 2020
  3. Primary completion5 Dec 2023
  4. Study completion5 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Model description
For a 12-months period patients undergoing aftercare treatment as usual are enrolled as an active control group. Subsequently, the intervention is implemented (StroCare treatment) and enrolment of the intervention group takes place for another 12 months. Patients in both groups are assessed after the index ischemic event and 12 months thereafter. Further sources of information are the medical record, the electronic portal (only intervention group), routine data provided by the collaborating BARMER health insurance agency (for the intervention and control group and additionally for a historic control).
Masking
None (open label)
Enrolment
409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04159324
Sponsor's protocol ID
01NVF18022
Acronym
StroCare
Status last verified
Dec 2023
First submitted
7 Nov 2019
Last updated
29 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Schrage T, Glissmann C, Thomalla G, Rimmele DL, Schmidt H, Rosenkranz M, Boskamp S, Harter M, Kriston L. Process evaluation of a cross-sectoral, coordinated follow-up care of stroke patients: a qualitative study. Neurol Res Pract. 2025 Jan 23;7(1):4. doi: 10.1186/s42466-024-00360-1.

    PubMed 39844272

  • Rimmele DL, Schrage T, Brettschneider C, Engels A, Gerloff C, Harter M, Rosenkranz M, Schmidt H, Kriston L, Thomalla G. Rationale and design of an interventional study of cross-sectoral, coordinated treatment of stroke patients with patient-orientated outcome measurement (StroCare). Neurol Res Pract. 2021 Feb 2;3(1):7. doi: 10.1186/s42466-021-00107-2.

    PubMed 33526148

Questions about this trial

What is this clinical trial studying?

A study testing optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported physical QoL: PROMIS-10 (time frame: 1 year after index ischemic event). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04159324, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

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