Enhanced Medical Rehabilitation for Disablement

Depression Clinical Trial

Official title:

Enhanced Acute Medical Rehabilitation for Disablement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951691
• Other study ID #: R34MH083868
• Secondary ID: DATR A4-GPS
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2009
• Last updated: March 18, 2014
• Start date: August 2009
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Hip Fracture
• Hip Fractures

Intervention

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.
• Treatment as usual
Standard treatment with physical and occupational therapies

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

Eric J. Lenze, MD, Helen H. Host, PhD, Mary W. Hildebrand, OTD, Nancy Morrow-Howell, PhD, Brian Carpenter, PhD, Kenneth E. Freedland, PhD, Carolyn A. Baum, PhD, David Dixon, PhD, Peter Doré, MS, Leah Wendleton, BA, Ellen F. Binder, MD.

Hildebrand, Mary W. OTD; Host, Helen H. PhD; Binder, Ellen F. MD; Carpenter, Brian PhD; Freedland, Kenneth E. PhD; Morrow-Howell, Nancy PhD; Baum, Carolyn M. PhD; Doré, Peter MA; Lenze, Eric J. MD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional recovery	Barthel Index. Secondary Measures are gait speed and 6 minute walk.	baseline, end of nursing home admission	No
Secondary	positive and negative affect	13 items assessing positive and negative affect	Measured from baseline to SNF discharge	No

External Links

•   Link
•   Link