Enhanced Medical Rehabilitation for Disablement
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hip Fracture Depression |
Behavioral: Enhanced acute medical rehabilitation Behavioral: Treatment as usual |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Enhanced Acute Medical Rehabilitation for Disablement |
- functional recovery [ Time Frame: baseline, end of nursing home admission ] [ Designated as safety issue: No ]Barthel Index. Secondary Measures are gait speed and 6 minute walk.
- positive and negative affect [ Time Frame: Measured from baseline to SNF discharge ] [ Designated as safety issue: No ]13 items assessing positive and negative affect
| Enrollment: | 25 |
| Study Start Date: | August 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Missouri | |
| Washington University in St. Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| Principal Investigator: | Eric Lenze, MD | Washington University in St. Louis |
More Information
No publications provided
| Responsible Party: | Eric Lenze, Professor of Psychiatry, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00951691 History of Changes |
| Other Study ID Numbers: | R34 MH083868, DATR A4-GPS |
| Study First Received: | August 3, 2009 |
| Last Updated: | September 24, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Washington University School of Medicine:
|
Elderly Acute Medical Rehabilitation |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Hip Fractures Behavioral Symptoms Mood Disorders Mental Disorders |
Femoral Fractures Fractures, Bone Wounds and Injuries Hip Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 23, 2013