StrokePhase 3PaReSiSNCT00687869
Participative Rehabilitation in Stroke Patients
A Phase 3 study testing Case management in people with Stroke, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Mar 2012
- Phase
- Phase 3
- 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
- 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
Who cannot join
- Reinfarction
- Alcoholism
- Death in acute care
- NIHHS > 25
- Homelessness
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)
Halle
About this study
Official title: Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"
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.
Read the detailed description
In a randomized trial, the project Participative rehabilitation process management "Stroke in Saxony-Anhalt" (PaReSiS) implements a case management trial, explicitly including all providers in the course of illness, treatment and rehabilitation. To achieve this, patients in the intervention group have the opportunity to choose, specifically and according to their own needs, from the offers of a web portal and a telephone hotline, from individual counselling and info sessions as well as from home visits. Patients in the control group receive patient-information-notes beyond primary care. There will be qualitative interviews with the persons concerned and/or their relatives in both groups in order to validate the instruments.
- Conditions
- Stroke
- Being tested
- Case management
- Keywords
- stroke, rehabilitation, patient care management, patient participation
- Medical subject headings
- Stroke, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementBehavioural
Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal
Case managementBehavioural
Usual stroke aftercare plus patient-information-notes
| Study group | Role | What they receive |
|---|---|---|
| Case management | Experimental | Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal Receives: Behavioral: Case management |
| usual care | Active comparator | Usual stroke aftercare plus patient-information-notes Receives: Behavioral: Case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical scale of the Stroke Impact Scale 3.0
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt, Deutsche Rentenversicherung, Universitätsklinik und Poliklinik für Neurologie
- Responsible party
- Principal investigator, Johann Behrens, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Johann Behrens, Prof. Dr., Principal investigator, Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687869
- Sponsor's protocol ID
- 01GX0711
- Acronym
- PaReSiS
- Status last verified
- Sep 2013
- First submitted
- 28 May 2008
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25920942
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"
- ClinicalTrials.gov ID
- NCT00687869
- Acronym / sponsor ID
- PaReSiS / 01GX0711
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, patient care management, patient participation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt, Deutsche Rentenversicherung, Universitätsklinik und Poliklinik für Neurologie
- Study start
- Jun 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In a randomized trial, the project Participative rehabilitation process management "Stroke in Saxony-Anhalt" (PaReSiS) implements a case management trial, explicitly including all providers in the course of illness, treatment and rehabilitation. To achieve this, patients in the intervention group have the opportunity to choose, specifically and according to their own needs, from the offers of a web portal and a telephone hotline, from individual counselling and info sessions as well as from home visits. Patients in the control group receive patient-information-notes beyond primary care. There will be qualitative interviews with the persons concerned and/or their relatives in both groups in order to validate the instruments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case management | Experimental | Behavioral: Case managementCase management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal |
| usual care | Active comparator | Behavioral: Case managementUsual stroke aftercare plus patient-information-notes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Reinfarction
- Alcoholism
- Death in acute care
- NIHHS > 25
- Homelessness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case managementCase management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal | Behavioural | Case management |
| Case managementUsual stroke aftercare plus patient-information-notes | Behavioural | usual care |
Primary outcome
physical scale of the Stroke Impact Scale 3.0
Time frame: 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
1 secondary outcome
Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
- Derived from this study: PubMed 25920942Saal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann Behrens, Prof. Dr. principal investigator
Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Case management in people with Stroke, run by Martin-Luther-Universität Halle-Wittenberg 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 4 inclusion and 5 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 19 Sep 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
physical scale of the Stroke Impact Scale 3.0 (time frame: 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). 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 NCT00687869, which also lists 1 linked publication.
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 19 Sep 2013; AzTrials last refreshed its copy on 7 Nov 2026.