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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

August 3, 2009
August 4, 2009
March 19, 2014
August 2009
January 2012   (Final data collection date for primary outcome measure)
functional recovery [ Time Frame: baseline, end of nursing home admission ]
Barthel Index. Secondary Measures are gait speed and 6 minute walk.
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) ]
Complete list of historical versions of study NCT00951691 on ClinicalTrials.gov Archive Site
positive and negative affect [ Time Frame: Measured from baseline to SNF discharge ]
13 items assessing positive and negative affect
Hip fracture recovery, as measured by the Hip Fracture Recovery Scale (HFRS) [ Time Frame: Measured from baseline to SNF discharge ]
Not Provided
Not Provided
 
Enhanced Medical Rehabilitation for Disablement
Enhanced Acute Medical Rehabilitation for Disablement
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Hip Fracture
  • Depression
  • 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
  • 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
  • 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.
 
Completed
25
40
January 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00951691
R34MH083868( U.S. NIH Grant/Contract )
DATR A4-GPS
Not Provided
Not Provided
Not Provided
Eric Lenze, Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Eric J Lenze, MD Washington University School of Medicine
Washington University School of Medicine
September 2012

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