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Completed

NCT Number: NCT00951691

Enhanced Medical Rehabilitation for Disablement

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced acute medical rehabilitation

Behavioral

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

Behavioral

Standard treatment with physical and occupational therapies

Primary outcomes

  1. functional recovery

    Time frame: baseline, end of nursing home admission

    Barthel Index. Secondary Measures are gait speed and 6 minute walk.

Secondary outcomes

  1. positive and negative affect

    Time frame: Measured from baseline to SNF discharge

    13 items assessing positive and negative affect

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Enhanced Acute Medical Rehabilitation for Disablement

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 4, 2009
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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