Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.

Completed

Phase N/A Results N/A

Trial Description

Objective: To evaluate the effect of interdisciplinary home rehabilitation of patients with acute stroke. The trial seeks to evaluate:
1. Can early home rehabilitation affect the degree of independence (motor capacity, activities of daily living and cognitive status), quality of life and the possibility of discharge to own home?
2. Can home rehabilitation influence the length of admission at a rehabilitation centre in the municipality, readmission to hospital, the use of healthcare services and death?
3. To what extend can home rehabilitation be implemented according to finances? Materials and methods: Patients at the age 18 years or more admitted to the stroke unit at the University Hospital of Gentofte. The patients were eligible when meeting the following criteria: symptoms of stroke, need of rehabilitation tree days after admission, living in own home in the Municipality of Gentofte, Lyngby-Taarbaek or Rudersdal and Modified Rankin Score between 0 and 3.
The trial was conducted as a randomised controlled trial. The control group patients were rehabilitated according to normal procedure. The intervention group patients were rehabilitated according to normal procedure and were additionally rehabilitated at home during admission and four weeks after discharge.

Detailed Description

Objectives were to assess the efficacy of home-based stroke rehabilitation compared to standard care in stroke patients using an interventional, randomised, safety/efficacy open-label trial and parallel assignment. The setting was single-center, stroke unit at the University Hospital of Copenhagen, Gentofte, although patients were recruited through a collaboration of several municipalities.
Participants were eligible patients with a clinical diagnosis of stroke and focal neurological deficits hospitalised in a stroke unit for more than three days and in need of rehabilitation.
Interventions patients were randomised to home-based rehabilitation during hospitalization and for up to 4 weeks after discharge to replace part of usual treatment and rehabilitation services. Control patients received treatment and rehabilitation following usual guidelines for the treatment of stroke patients.
Main outcome measures 90 days post-stroke, modified Rankin Scale, and motor rehabilitation, cognitive abilities, quality of life and treatment-associated economy as secondary outcomes.

Conditions

Interventions

  • Standard Care Behavioral
    Intervention Desc: Standard care during hospital stay and in the municipality after discharge
    ARM 1: Kind: Experimental
    Label: Control
    Description: Control patients treated following standard care procedures in our department with no interference from the interventional team.
  • Home rehabilitation Other
    Intervention Desc: Home rehabilitation during hospital stay and after discharge
    ARM 1: Kind: Experimental
    Label: 1
  • Regular rehabilitation Other
    Intervention Desc: Regular rehabilitation during hospital stay and in the municipality after discharge
    ARM 1: Kind: Experimental
    Label: 2
  • Home-based rehabilitation Other
    Other Names: Rehabilitation at home
    Intervention Desc: Rehabilitation at home during hospital stay and after discharge
    ARM 1: Kind: Experimental
    Label: Intervention
    Description: Patients treated by an interdisciplinary, intersectoral and interventional team responsible for providing home-based rehabilitation.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Health Services Research
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Can early home rehabilitation affect the degree of independence, quality of life and the possibility of discharge to own home and influence the length of admission at a rehabilitation centre in the municipality and readmission to hospital 180 days No
Secondary To what extend can home rehabilitation be implemented according to finances? 180 No
Primary modified Rankin Scale 90 days No
Secondary EuroQol-5Dâ„¢ quality of life measurement 90 No
Secondary Barthel-100 Index 90 No
Secondary Motor Assessment Scale 90 No
Secondary CT-50 Cognitive Test 90 No

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