NCT00951691

Brief Summary

This study will develop and test a new program of enhanced medical rehabilitation for elderly people who have had an acute disabling medical event and are admitted to a skilled nursing facility for post-acute rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2009

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

Study Start

First participant enrolled

August 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 19, 2014

Status Verified

September 1, 2012

Enrollment Period

2.4 years

First QC Date

August 3, 2009

Last Update Submit

March 18, 2014

Conditions

Hip FractureDepression

Keywords

ElderlyAcute Medical Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • functional recovery

    Barthel Index. Secondary Measures are gait speed and 6 minute walk.

    baseline, end of nursing home admission

Secondary Outcomes (1)

  • positive and negative affect

    Measured from baseline to SNF discharge

Study Arms (2)

Enhanced acute medical rehabilitation

EXPERIMENTAL

Participants will receive enhanced acute medical rehabilitation.

Behavioral: Enhanced acute medical rehabilitation

Treatment as usual

ACTIVE COMPARATOR

Participants will receive treatment as usual.

Behavioral: Treatment as usual

Interventions

Enhanced acute medical rehabilitationBEHAVIORAL

Daily up to 3-hour sessions of enhanced physical and occupational therapies (see Lenze et al, "Enhanced Medical Rehabilitation Increases Therapy Intensity and Engagement and Improves Functional Outcomes in Postacute Rehabilitation of Older Adults: A Randomized-Controlled Trial." J American Medical Director's Association, 2012 for details and outcome data.

Enhanced acute medical rehabilitation
Treatment as usualBEHAVIORAL

Standard treatment with physical and occupational therapies

Treatment as usual

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to Barnes Extended Care nursing home
  • Acute disablement
  • (criterion dropped) Clinically depressive symptoms, including a score of 15 or greater on the Hamilton Depression Rating Scale (HAM-D) and depressed mood or anhedonia present more days than not since the fracture

You may not qualify if:

  • Unable to provide informed consent due to dementia and severe persistent delirium
  • Inability to cooperate with the protocol
  • Cardiac or other medical instability that would preclude carrying out high intensity exercises
  • Language, visual, or hearing barriers to participation
  • Presence of pelvic fractures that do not involve the proximal femur
  • Presence of metastatic cancer, including cancer that causes a pathological fracture
  • Bilateral acute hip fractures
  • Lifetime psychosis or mania
  • Alcohol or substance dependence within 6 months, or current (prior to hip fracture) alcohol or substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • Hildebrand, Mary W. OTD; Host, Helen H. PhD; Binder, Ellen F. MD; Carpenter, Brian PhD; Freedland, Kenneth E. PhD; Morrow-Howell, Nancy PhD; Baum, Carolyn M. PhD; DorĂ©, Peter MA; Lenze, Eric J. MD.

    BACKGROUND

  • Lenze EJ, Host HH, Hildebrand MW, Morrow-Howell N, Carpenter B, Freedland KE, Baum CA, Dixon D, Dore P, Wendleton L, Binder EF. Enhanced medical rehabilitation increases therapy intensity and engagement and improves functional outcomes in postacute rehabilitation of older adults: a randomized-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):708-12. doi: 10.1016/j.jamda.2012.06.014. Epub 2012 Aug 3.

    PMID: 22863663RESULT

  • Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.

    PMID: 34766330DERIVED

Related Links

MeSH Terms

Conditions

Hip FracturesDepression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesBehavioral SymptomsBehavior

Study Officials

  • Eric J Lenze, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 19, 2014

Record last verified: 2012-09

Locations

US(1)