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
|Condition or disease||Intervention/treatment||Phase|
|Disabling Medical Events Disabled Depression||Behavioral: Enhanced Medical Rehabilitation Behavioral: Standard of Care Rehabilitation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|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.
- Change from Baseline in Barthel Index score [ Time Frame: Baseline, Day 30, Day 60, Day 90, Discharge (expected average is 3 weeks) ]
- 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) ]
- Change from Baseline in Distance Ambulated in 6-Minute Walk Test [ Time Frame: Baseline, Discharge (expected average is 3 weeks) ]
- 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)
- Change from Baseline in Positive and Negative Affect Scale [ Time Frame: Baseline, Day 30, 60, 90, Discharge (expected average is 3 weeks) ]
- Instances of Re-hospitalization [ Time Frame: Day 30, 60, 90, Discharge (expected average is 3 weeks) ]
- Change from Baseline in living and ambulatory status [ Time Frame: Baseline, Day 30, Day 60, Day 90, Discharge (expected average is 3 weeks) ]
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
|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|
|Principal Investigator:||Eric Lenze, MD||Washington University School of Medicine|