Enhanced Medical Rehabilitation for Disablement
Primary Purpose
Hip Fracture, Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enhanced acute medical rehabilitation
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fracture focused on measuring Elderly, Acute Medical Rehabilitation
Eligibility Criteria
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Enhanced acute medical rehabilitation
Treatment as usual
Arm Description
Participants will receive enhanced acute medical rehabilitation.
Participants will receive treatment as usual.
Outcomes
Primary Outcome Measures
functional recovery
Barthel Index. Secondary Measures are gait speed and 6 minute walk.
Secondary Outcome Measures
positive and negative affect
13 items assessing positive and negative affect
Full Information
NCT ID
NCT00951691
First Posted
August 3, 2009
Last Updated
March 18, 2014
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00951691
Brief Title
Enhanced Medical Rehabilitation for Disablement
Official Title
Enhanced Acute Medical Rehabilitation for Disablement
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Depression
Keywords
Elderly, Acute Medical Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced acute medical rehabilitation
Arm Type
Experimental
Arm Description
Participants will receive enhanced acute medical rehabilitation.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced acute medical rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Standard treatment with physical and occupational therapies
Primary Outcome Measure Information:
Title
functional recovery
Description
Barthel Index. Secondary Measures are gait speed and 6 minute walk.
Time Frame
baseline, end of nursing home admission
Secondary Outcome Measure Information:
Title
positive and negative affect
Description
13 items assessing positive and negative affect
Time Frame
Measured from baseline to SNF discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Lenze, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
22863663
Citation
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.
Results Reference
result
PubMed Identifier
34766330
Citation
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.
Results Reference
derived
Links:
URL
http://journals.lww.com/ajpmr/Abstract/2012/08000/Measuring_Treatment_Fidelity_in_a_Rehabilitation.10.aspx
Description
Related Info
URL
http://dx.doi.org/10.1016/j.jamda.2012.06.014
Description
Related Info
Learn more about this trial
Enhanced Medical Rehabilitation for Disablement
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