Enhanced Medical Rehabilitation for Disablement

Phase 2

Completed

• Conditions: Hip Fracture; Depression
• Interventions: Behavioral: Enhanced acute medical rehabilitation; Behavioral: Treatment as usual

• Registration Number: NCT00951691
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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 Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-09
• Last Update Submitted: 2014-03-18
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced acute medical rehabilitation	Enhanced acute medical rehabilitation	Participants will receive enhanced acute medical rehabilitation.
Treatment as usual	Treatment as usual	Participants will receive treatment as usual.

Primary Outcome Measures

Name	Time	Method
functional recovery	baseline, end of nursing home admission	Barthel Index. Secondary Measures are gait speed and 6 minute walk.

Secondary Outcome Measures

Name	Time	Method
positive and negative affect	Measured from baseline to SNF discharge	13 items assessing positive and negative affect

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States