NCT02062541

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

February 12, 2014

Last Update Submit

February 1, 2017

Conditions

Functionally-Impaired Elderly

Keywords

functional assessmentrehabilitationcross-sectorial cooperation

Outcome Measures

Primary Outcomes (1)

  • 30-second-chair-stand test

    up to 14 days after admission date

Study Arms (4)

Funct. assessment+fast rehabilitation

EXPERIMENTAL

Funct. assessment+fast rehabilitation

Other: Funct. assessment+fast rehabilitation

Funct. assessment+usual rehabilitation

EXPERIMENTAL

Funct. assessment+usual rehabilitation

Other: Funct. assessment+usual rehabilitation

usual assessment+fast rehabilitation

EXPERIMENTAL

usual assessment+fast rehabilitation

Other: usual assessment+fast rehabilitation

usual assessment+usual rehabilitation

NO INTERVENTION

usual assessment+usual rehabilitation

Interventions

Funct. assessment+fast rehabilitationOTHER
Funct. assessment+fast rehabilitation
Funct. assessment+usual rehabilitationOTHER
Funct. assessment+usual rehabilitation
usual assessment+fast rehabilitationOTHER
usual assessment+fast rehabilitation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lillebaelt hospital

Kolding, 6000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24939812DERIVED

Study Officials

  • Christian B Mogensen, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 13, 2014

Study Start

June 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

DK(1)