Progressing Home Health Rehabilitation for Older Adults

Recruiting in Palo Alto (17 mi)

Overseen by Jennifer E Stevens-Lapsley, MPT, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Trial Summary

What is the purpose of this trial?

This research study explores the effects of a progressive, multi-component intervention following a stay in the hospital or rehabilitation facility. The purpose of this research study is to compare a multi-component intervention (higher intensity exercise, nutritional supplementation, and greater emphasis on functionally enhanced care transitions) with usual care physical therapy.

Research Team

Jennifer E Stevens-Lapsley, MPT, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

Inclusion Criteria

65 years of age and older

Referred to home care physical therapy following acute medical deconditioning

Chronic Obstructive Pulmonary Disease

Treatment Details

Interventions

• Progressive Multi-Component (Behavioral Intervention)
• Usual Care (Behavioral Intervention)

Participant Groups

Group I: Progressive Multi-Component (PMC) Experimental Treatment 1 Intervention

High intensity strength training protocol, daily protein supplementation, functionally enhanced transitions of care

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

Low intensity rehabilitation protocol, standard education for nutrition, standard transitions of care Name of Participant Arm updated to "Enhanced Usual Care" from "Usual Care" effective 8/16/18 to distinguish from Passive Comparator "True Usual Care" group.

Group III: True Usual Care (TUC) Active Control 1 Intervention

Real-world home health rehabilitation, real-world education for nutrition, real-world transitions of care, non-randomized observation Participants in the "True Usual Care" group will receive physical therapy following discharge from acute hospitalization. Activities and number of visits are not protocolized and are provided by real world home health care providers per physician orders. Participant Arm added effective 8/16/18.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Arcadia University

Collaborator

Trials

8

Recruited

1,000+