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

NCT00626353 | Completed DMC

• 1 other identifier: H-A-2007-0027
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the effect of interdisciplinary home rehabilitation of patients with acute stroke. The trial seeks to evaluate:

1. 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. 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. 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.

Conditions

Acute Stroke

Keywords

Stroke; rehabilitation; motor recovery; cognition; quality of life

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale

  To investigate differences in the modified Rankin Scale among intervention and control patients at the inclusion time point and 90 days later.

  90 days

Secondary Outcomes (4)

• EuroQol-5D™ quality of life measurement

  90

• Barthel-100 Index

  90

• Motor Assessment Scale

  90

• CT-50 Cognitive Test

  90

Other Outcomes (2)

• Body Mass Index

  90

• Economy

  90

Study Arms (2)

Intervention

EXPERIMENTAL

Patients treated by an interdisciplinary, intersectoral and interventional team responsible for providing home-based rehabilitation.

Other: Home-based rehabilitation

Control

ACTIVE COMPARATOR

Control patients treated following standard care procedures in our department with no interference from the interventional team.

Other: Standard care

Interventions

Home-based rehabilitation OTHER

Rehabilitation at home during hospital stay and after discharge

Also known as: Rehabilitation at home

Intervention

Standard care OTHER

Standard care during hospital stay and in the municipality after discharge

Also known as: Regular rehabilitation stroke treatment

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or more,
• Symptoms of stroke,
• Need of rehabilitation tree days after admission,
• Living in own home,
• Modified Rankin Score between 0 and 3

You may not qualify if:

• Terminal care,
• Discharged from another department, Living in nursery home,
• Can not understand the Danish language,
• Memory difficulties

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Ministry of the Interior and Health, Denmark: collaborator

Study Sites (1)

University hospital of Gentofte

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Finn Roenholt, PhD

  University Hospital of Copenhagen, Gentofte Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MA, PhD

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: July 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

DK (1)