Improving Function, Participation and Function After Acute Hospitalization in Older Adults

Frail Older Adults Clinical Trial

Official title:

Improving Activity, Participation And Function After Acute Hospitalization In Older Adults With Multiple Chronic Conditions: Phase II Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872637
• Other study ID #: 10-0432
• Secondary ID: Innovator's Fund
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: May 15, 2017
• Start date: June 2011
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Older Adults

Intervention

Behavioral:
• Progressive Multi-Component Intervention

• Usual Care

Locations

Country	Name	City	State
United States	University of Colorado Denver, Anschutz Medical Campus	Aurora	Colorado
United States	Arcadia University	Glenside	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Arcadia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Speed	Time it takes to walk a 4 meter path, key to independent functioning	60 days
Secondary	Modified Physical Performance Test (mPPT)	Assesses 7 different tasks. Based on the time taken to complete the tasks, a score from 0 (unable to complete) to 4 (performed quickly and easily) if given for each task. A maximal score of 28 is given, including tasks that involved the upper and lower extremity function.	60 days
Secondary	Late-Life Function and Disability Instrument (LLFDI)	Evaluates limitation and frequency of taking part in 16 major life tasks in its disability component, and 32 functional tasks in its functional component, of which 14 tasks comprise basic lower extremity function.	60 days