Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Older Adults
  • Physical Deconditioning
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 100 years
Gender
Both males and females

Description

Declines in physical function as a result of acute illness are strongly and independently associated with a number of adverse health events for older adults. Home Health (HH) physical therapy may be the ideal venue for addressing these declines in physical function because around 3 million older adu...

Declines in physical function as a result of acute illness are strongly and independently associated with a number of adverse health events for older adults. Home Health (HH) physical therapy may be the ideal venue for addressing these declines in physical function because around 3 million older adults receive HH services following discharge from acute or post-acute facilities. However, as currently structured, HH care does not appear to adequately restore function, as evidenced by poor long-term outcomes and high rates of hospital readmission. Diminished physical function has been particularly implicated as a risk factor for re-hospitalization --older adults with lower levels of ambulatory activity are 6 times more likely to be re-hospitalized than those with greater ambulatory activity. A more intensive approach to HH physical therapy for older adults has great potential to maximize physical function and reduce hospital readmissions. Therefore, the investigators have developed a high intensity home-based, progressive, interdisciplinary, multi-component (PMC) intervention that directly addresses the functional deficits seen after hospitalization. This intervention will include intensive rehabilitation, a care transitions program, and daily protein supplementation. The investigators will conduct a two-arm, randomized clinical trial (RCT) of 200 participants admitted to HH from an acute or post-acute facility. Participants will receive either 1) an intensive, PMC intervention using resistance exercise and evidenced-based motor control training to improve physical function, along with nutritional supplementation and emphasis on functionally enhanced care transitions or 2) usual care (UC) physical therapy. The primary goal of this investigation is to determine if PMC intervention, initiated upon admission to HH, improves physical function, as measured by performance and self-report assessments, more than UC physical therapy. The investigators will also examine the effects on fatigue, balance confidence, and activities of daily living. In an exploratory analysis, the effects of the PMC intervention on re-hospitalization rates, nursing home placement, emergency room visits, and falls after discharge from the acute care hospital will also be examined. All outcomes will be examined at baseline, 30, 60 (primary endpoint), 90 and 180 days. If successful in improving patient function and decreasing re-hospitalization rates, PMC intervention holds potential for future health care cost savings.

Tracking Information

NCT #
NCT02905370
Collaborators
  • National Institute of Nursing Research (NINR)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Arcadia University
Investigators
Principal Investigator: Jennifer E Stevens-Lapsley, MPT, PhD University of Colorado, Denver