Participative Rehabilitation in Stroke Patients "PaReSiS"

Completed

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Case management Behavioral
    Intervention Desc: Usual stroke aftercare plus patient-information-notes
    ARM 1: Kind: Experimental
    Label: 1
    ARM 2: Kind: Experimental
    Label: 2
    ARM 3: Kind: Experimental
    Label: Case management
    Description: Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal
    ARM 4: Kind: Experimental
    Label: usual care
    Description: Usual stroke aftercare plus patient-information-notes

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Health Services Research
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Physical and cognitive capacity using the Functional Independence Measure (FIM) at 1 year after discharge No
Secondary Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND three days before discharge home - one year after intervention begins No
Primary physical scale of the Stroke Impact Scale 3.0 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 No

Sponsors