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Completed

NCT Number: NCT00687869

Participative Rehabilitation in Stroke Patients

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Health Behavior Nervous System Diseases Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Halle, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Case Management

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Collaborators

  • Deutsche Rentenversicherung
  • Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt
  • Universitätsklinik und Poliklinik für Neurologie

Registry information

Official study title

Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"

Acronym: PaReSiS

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2008
Registry last updated
Sep 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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