Enhanced Medical Rehabilitation for Disablement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00951691
First received: August 3, 2009
Last updated: March 18, 2014
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951691

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Eric J Lenze, MD Washington University School of Medicine
  More Information

Additional 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: March 18, 2014
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 August 28, 2014