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

NCT ID: NCT02062541

Last Updated: 2017-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Functionally-Impaired Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Funct. assessment+fast rehabilitation

Funct. assessment+fast rehabilitation

Group Type EXPERIMENTAL

Funct. assessment+fast rehabilitation

Intervention Type OTHER

Funct. assessment+usual rehabilitation

Funct. assessment+usual rehabilitation

Group Type EXPERIMENTAL

Funct. assessment+usual rehabilitation

Intervention Type OTHER

usual assessment+fast rehabilitation

usual assessment+fast rehabilitation

Group Type EXPERIMENTAL

usual assessment+fast rehabilitation

Intervention Type OTHER

usual assessment+usual rehabilitation

usual assessment+usual rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Funct. assessment+fast rehabilitation

Intervention Type OTHER

Funct. assessment+usual rehabilitation

Intervention Type OTHER

usual assessment+fast rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sygehus Lillebaelt

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Christian Backer Mogensen

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian B Mogensen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

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Lillebaelt hospital

Kolding, , Denmark

Site Status

Countries

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Denmark

References

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Bruun IH, Norgaard B, Maribo T, Schiottz-Christensen B, Mogensen CB. The effect on physical performance of a functional assessment and immediate rehabilitation of acutely admitted elderly patients with reduced functional performance: the design of a randomised clinical trial. BMJ Open. 2014 Jun 17;4(6):e005252. doi: 10.1136/bmjopen-2014-005252.

Reference Type DERIVED
PMID: 24939812 (View on PubMed)

Other Identifiers

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SLB-ED-02-2014

Identifier Type: -

Identifier Source: org_study_id

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