Working... Menu
Trial record 44 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

Enhanced Medical Rehabilitation for Disablement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00951691
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : March 19, 2014
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Hip Fracture Depression Behavioral: Enhanced acute medical rehabilitation Behavioral: Treatment as usual Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhanced Acute Medical Rehabilitation for Disablement
Study Start Date : August 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Enhanced acute medical rehabilitation
Participants will receive enhanced acute medical rehabilitation.
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.

Active Comparator: Treatment as usual
Participants will receive treatment as usual.
Behavioral: Treatment as usual
Standard treatment with physical and occupational therapies

Primary Outcome Measures :
  1. functional recovery [ Time Frame: baseline, end of nursing home admission ]
    Barthel Index. Secondary Measures are gait speed and 6 minute walk.

Secondary Outcome Measures :
  1. positive and negative affect [ Time Frame: Measured from baseline to SNF discharge ]
    13 items assessing positive and negative affect

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00951691

Layout table for location information
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Layout table for investigator information
Principal Investigator: Eric J Lenze, MD Washington University School of Medicine

Additional Information:
Publications of Results:
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.

Other 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.

Layout table for additonal information
Responsible Party: Eric Lenze, Professor of Psychiatry, Washington University School of Medicine Identifier: NCT00951691     History of Changes
Other Study ID Numbers: R34MH083868 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: September 2012

Keywords provided by Eric Lenze, Washington University School of Medicine:
Acute Medical Rehabilitation

Additional relevant MeSH terms:
Layout table for MeSH terms
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries