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Enhanced Medical Rehabilitation for Disablement

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ClinicalTrials.gov Identifier: NCT00951691
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE August 3, 2009
First Posted Date  ICMJE August 4, 2009
Last Update Posted Date March 19, 2014
Study Start Date  ICMJE August 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
functional recovery [ Time Frame: baseline, end of nursing home admission ]
Barthel Index. Secondary Measures are gait speed and 6 minute walk.
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2009)
Change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Measured at baseline and discharge from the skilled nursing facility (SNF) ]
Change History Complete list of historical versions of study NCT00951691 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
positive and negative affect [ Time Frame: Measured from baseline to SNF discharge ]
13 items assessing positive and negative affect
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2009)
Hip fracture recovery, as measured by the Hip Fracture Recovery Scale (HFRS) [ Time Frame: Measured from baseline to SNF discharge ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhanced Medical Rehabilitation for Disablement
Official Title  ICMJE Enhanced Acute Medical Rehabilitation for Disablement
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.
Detailed Description

Disabling medical events are common for elderly people, causing immobilization, requiring extensive rehabilitation, and generating fears of loss of function and need for institutionalization. Existing acute medical rehabilitation settings—skilled nursing facilities (SNFs) and inpatient rehabilitation facilities (IRFs)—often do not adequately meet the needs of depressed elders, resulting in a missed opportunity for effective and functional recovery. This study will test a new program that will enhance acute rehabilitation in SNFs to target mood, motivation, and functional recovery in the 2 to 4 weeks after hospitalization. This program, developed by the research team, increases the intensity and engagement of physical therapy (PT) and occupational therapy (OT).

Participation in this study will last until discharge from the SNF, with follow-up assessments lasting until 3 months after entry. Participants will be randomly assigned to receive either the enhanced acute medical rehabilitation or treatment as usual. Participants receiving the enhanced care will complete up to 3 hours of enhanced PT and OT per day from study entry until discharge, excluding weekends. Participants receiving treatment as usual will receive standard PT and OT. Study assessments will take place at baseline, after 8 and 15 days, and after discharge. Follow-up assessments will occur after 30, 60, and 90 days. Assessments will include questionnaires and interviews measuring positive and negative affect, and functional impairment and disability.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hip Fracture
  • Depression
Intervention  ICMJE
  • Behavioral: Enhanced acute medical rehabilitation
    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.
  • Behavioral: Treatment as usual
    Standard treatment with physical and occupational therapies
Study Arms  ICMJE
  • Experimental: Enhanced acute medical rehabilitation
    Participants will receive enhanced acute medical rehabilitation.
    Intervention: Behavioral: Enhanced acute medical rehabilitation
  • Active Comparator: Treatment as usual
    Participants will receive treatment as usual.
    Intervention: Behavioral: Treatment as usual
Publications *
  • 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; Doré, Peter MA; Lenze, Eric J. MD.
  • Eric J. Lenze, MD, Helen H. Host, PhD, Mary W. Hildebrand, OTD, Nancy Morrow-Howell, PhD, Brian Carpenter, PhD, Kenneth E. Freedland, PhD, Carolyn A. Baum, PhD, David Dixon, PhD, Peter Doré, MS, Leah Wendleton, BA, Ellen F. Binder, MD.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2012)
25
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2009)
40
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00951691
Other Study ID Numbers  ICMJE R34MH083868( U.S. NIH Grant/Contract )
DATR A4-GPS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Lenze, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric J Lenze, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP