Clinical trial NCT01872637: Improving Function, Participation and Function After Acute Hospitalization in Older Adults
Official title: Improving Activity, Participation And Function After Acute Hospitalization In Older Adults With Multiple Chronic Conditions: Phase II Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Older Adults
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Arcadia University
First posted: 2013-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hospitalization increases the risk for new disability in older adults. In the current health care system, home health physical therapy is understudied and often does not return older adults to prior levels of function. The proposed evidence-based multicomponent intervention that combines high intensity strength training and motor control based systems of gait and balance training will advance clinical practice by providing an intervention strategy for practitioners. If successful, improving patient function and decreasing re-hospitalization rates and falls will have large cost saving implications.

Detailed description: Background: Hospitalized older adults are 59.8 times more likely to develop disability than those who are not hospitalized. No studies have examined the effectiveness of Home Health (HH) physical therapy on improving function in older adults with multiple co-morbidities after hospitalization. Our goal is to enable older adults with multiple chronic conditions to recover function by providing adequate content and dose of intervention after hospitalization. This intervention is designed to work within the existing Medicare system and has potential for immediate clinical impact.

Purpose: The primary aim of our study is to determine if a progressive multi-component (PMC) intervention, initiated upon discharge from an acute care hospital, improves gait speed at the end of one 60-day episode of care, more than documented usual care (UC) physical therapy. We hypothesize that there will be a greater improvement in gait speed measured for the PMC group compared to the UC group following one episode of care. Benefits of PMC will be apparent at the end of usual care and will increase further at the end of the 60 day episode of care (primary endpoint).

Design: We propose to conduct a single blind randomized two arm clinical trial (RCT) in older adults discharged from acute care and referred to HH physical therapy. Both interventions (PMC \& UC) will be Medicare-reimbursed. All assessments and interventions will occur in the patients' homes.

Methods: Twenty individuals who are 65 years of age or older with multiple co-morbid conditions will be enrolled.

Eligibility criteria: Inclusion Criteria:

* 65 years or older
* referred to home care physical therapy
* have at least 3 comorbid conditions
* ambulatory without human assistance prior to hospitalization

Exclusion Criteria:

* acute lower extremity fractures with weight-bearing restriction
* elective joint replacement surgery
* active cancer diagnosis
* acute cardiac surgery
* lower extremity amputation
* referred to hospice home health physical therapy
* dialysis
* hospice care

Primary outcomes:
measure: Gait Speed
timeFrame: 60 days
Secondary outcomes:
measure: Modified Physical Performance Test (mPPT)
timeFrame: 60 days
measure: Late-Life Function and Disability Instrument (LLFDI)
timeFrame: 60 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Medical Campus
state: Colorado
city: Glenside
country: United States
facility: Arcadia University
state: Pennsylvania
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer E Stevens-Lapsley, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arcadia University
name: Kate Mangione, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: