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Enhanced Medical Rehabilitation in Older Adults (EMR)

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.
 
ClinicalTrials.gov Identifier: NCT02114879
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : June 17, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine

Brief Summary:
The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an effective treatment for older adults after disabling medical events.

Condition or disease Intervention/treatment Phase
Disabling Medical Events Disabled Depression Behavioral: Enhanced Medical Rehabilitation Behavioral: Standard of Care Rehabilitation Not Applicable

Detailed Description:

The intervention involves physical and occupational therapy for patients who have been admitted to a skilled nursing facility for therapy following a disabling medical event.

Participants in this study will be randomly assigned to receive either Enhanced or standard of care therapy, meaning they will either receive their PT (Physical Therapy)& OT(Occupational Therapy) from therapists who have been specially trained in the study intervention or from therapists with normal training. Participants will be assessed at baseline, 30, 60, and 90 days after baseline, and at the date of their discharge from the skilled nursing facility.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhanced Medical Rehabilitation in Older Adults
Actual Study Start Date : July 29, 2014
Actual Primary Completion Date : July 13, 2018
Actual Study Completion Date : July 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Standard of Care Rehabilitation Behavioral: Standard of Care Rehabilitation
Daily PT/OT provided by therapists not trained in the treatment intervention.

Experimental: Enhanced Medical Rehabilitation Behavioral: Enhanced Medical Rehabilitation
Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.




Primary Outcome Measures :
  1. Change from Baseline in Barthel Index score [ Time Frame: Baseline, Day 30, Day 60, Day 90, Discharge (expected average is 3 weeks) ]

Secondary Outcome Measures :
  1. Change from Baseline in Gait Speed (determined by 4 or 10 meter walk test) [ Time Frame: Baseline, Day 30, Discharge (expected average is 3 weeks) ]
  2. Change from Baseline in Distance Ambulated in 6-Minute Walk Test [ Time Frame: Baseline, Discharge (expected average is 3 weeks) ]
  3. Change from Baseline in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, Day 30, 60,90, Discharge (expected average is 3 weeks) ]
    only for patients with depression at baseline per SCID (Structured Clinical Interview for DSM IV)

  4. Change from Baseline in Positive and Negative Affect Scale [ Time Frame: Baseline, Day 30, 60, 90, Discharge (expected average is 3 weeks) ]

Other Outcome Measures:
  1. Instances of Re-hospitalization [ Time Frame: Day 30, 60, 90, Discharge (expected average is 3 weeks) ]
  2. Change from Baseline in living and ambulatory status [ Time Frame: Baseline, Day 30, Day 60, Day 90, Discharge (expected average is 3 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 65 and older
  • Admitted to a skilled nursing facility for post-acute care from PT and OT for 2 weeks or more.

Exclusion Criteria:

  • Language, visual or hearing barriers to participation
  • Medical illness preventing study participation or accurate data collection
  • Moderate-severe dementia (demonstrated by chart diagnosis and/or short blessed score greater than 13)
  • Progressive neurological condition such that recovery of function is not feasible
  • Patient did not have the ability to walk prior to hospitalization (e.g. paraplegic)
  • Schizophrenia or other chronic or current psychotic disorder.

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 ClinicalTrials.gov identifier (NCT number): NCT02114879


Locations
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United States, Missouri
Barnes-Jewish Extended Care
Saint Louis, Missouri, United States, 63105
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Alexian Brothers Sherbrooke Village
Saint Louis, Missouri, United States, 63125
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Eric Lenze, MD Washington University School of Medicine

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Lenze, Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02114879     History of Changes
Other Study ID Numbers: R01 MH099011A1
5R01MH099011-02 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Lenze, Washington University School of Medicine:
Physical Therapy
Occupational Therapy
Rehabilitation
Older adults
Depression
Physical Functioning
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms