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
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture Depression||Behavioral: Enhanced acute medical rehabilitation Behavioral: Treatment as usual||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- functional recovery [ Time Frame: baseline, end of nursing home admission ]Barthel Index. Secondary Measures are gait speed and 6 minute walk.
- positive and negative affect [ Time Frame: Measured from baseline to SNF discharge ]13 items assessing positive and negative affect
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): NCT00951691
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Eric J Lenze, MD||Washington University School of Medicine|