Enhanced Medical Rehabilitation for Disablement
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
25 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal