Enhanced Medical Rehabilitation for Disablement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhanced Acute Medical Rehabilitation for Disablement

Conditions
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Hip Fracture, Depression

Intervention / Treatment
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* Behavioral: Enhanced acute medical rehabilitation
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced acute medical rehabilitation<br>Participants will receive enhanced acute medical rehabilitation. | Behavioral: Enhanced acute medical rehabilitation<br>* 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.<br>|
| Active Comparator: Treatment as usual<br>Participants will receive treatment as usual. | Behavioral: Treatment as usual<br>* Standard treatment with physical and occupational therapies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional recovery | Barthel Index. Secondary Measures are gait speed and 6 minute walk. | baseline, end of nursing home admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive and negative affect | 13 items assessing positive and negative affect | Measured from baseline to SNF discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Acute Medical Rehabilitation