Effect of Functional Assessment and Immediate Rehabilitation of ED Admitted Elderly With Reduced Functional Performance

February 1, 2017 updated by: Christian Backer Mogensen, University of Southern Denmark

Background: Illness and hospitalisation, even of short duration, pose separate risks for permanently reduced functional performance in elderly medical patients. Functional assessment in the acute pathway will ensure early detection of declining performance and form the basis for mobilisation during hospitalisation and subsequent rehabilitation. For optimal results rehabilitation should begin immediately after discharge.

The aim of this study is to investigate the effect of a systematic functional assessment in the emergency departments (ED) of elderly medical patients with reduced functional performance when combined with immediate post-discharge rehabilitation.

Method/design: The study is a two-way factorial randomised clinical trial. Participants will be recruited among patients admitted to the ED who are above 65 years of age with reduced functional performance. Patients will be randomly assigned to one of four groups: 1) functional assessment and immediate rehabilitation; 2) functional assessment and usual rehabilitation; 3) usual assessment and immediate rehabilitation; 4) usual assessment and usual rehabilitation.

Primary outcome: 30-second chair-stand test administered at admission and two weeks after discharge.

We hypothesise that such assessment in the ED or/and immediate rehabilitation will result in sustained or improved performance in comparison to regimen in which neither of these interventions are offered.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

336

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Kolding, Denmark, 6000
        • Lillebaelt Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medical patients of 65 years of age or older admitted to the ED
  • Can speak and understand Danish
  • Resident in either of the two included municipalities
  • Can report personal data and decide on consent
  • Are able to sit on an chair and perform ≤ 9 repetitions at the 30-s. chair-stand test

Exclusion Criteria:

  • Patients suffering from a progressive neurological or cognitive deficit or disease.
  • Patients ordinarily unable to walk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Funct. assessment+fast rehabilitation
Funct. assessment+fast rehabilitation
Other: Funct. assessment+fast rehabilitation
EXPERIMENTAL: Funct. assessment+usual rehabilitation
Funct. assessment+usual rehabilitation
Other: Funct. assessment+usual rehabilitation
EXPERIMENTAL: usual assessment+fast rehabilitation
Other: usual assessment+fast rehabilitation
NO_INTERVENTION: usual assessment+usual rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30-second-chair-stand test
Time Frame: up to 14 days after admission date
up to 14 days after admission date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Sygehus Lillebaelt

Investigators

  • Principal Investigator: Christian B Mogensen, PhD, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (ESTIMATE)

February 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SLB-ED-02-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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