Implementing 3-Step Workout for Life in Home Health

July 11, 2023 updated by: University of Florida

Implementing 3-Step Workout for Life to Improve ADL Outcome in Home Health

The purpose of this project is to study how to adapt and implement the 3-Step Workout for Life program in a local home health agency. A series of learning cycles will be conducted to adjust the treatment dose and delivery mode. The specific aims include to evaluate the implementation outcomes and clinical outcomes, and to identify facilitators and barriers associated with the implementation.

Study Overview

Detailed Description

Medicare beneficiaries admitted to home health agencies are often in a frail status with decreased muscle strength and difficulty in performing activities of daily living. The purpose of the proposed research is to study how to adapt and implement the 3-Step Workout for Life program by the physical therapists and occupational therapists in a local home health agency. A series of learning cycles will be conducted to adjust the treatment dose and delivery mode, so that the program can be implemented at low cost but remains effective in improving self-care ability for Medicare beneficiaries. The specific aims include to evaluate the implementation outcomes and clinical outcomes, and to identify facilitators and barriers associated with the implementation.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • is a Medicare beneficiary
  • admitted to the partnered home health agency
  • show or experience muscle weakness
  • demonstrate functional limitation on at least one of the OASIS self-care items

Exclusion Criteria:

  • has an acute fracture with surgical or weight-bearing restrictions
  • has elective joint replacement surgery
  • has a lower extremity amputation
  • is receiving active treatment for cancer diagnosis
  • has on-going dialysis treatment
  • had acute cardiac surgery
  • with acute stroke or neurologic disorder that limits motor movements
  • in terminal stages of congestive heart failure
  • has been referred to hospice care
  • has severe cognitive deficits limiting verbal communication
  • has significant medical complications that preclude safe participation in resistance exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implementation Arm
Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care.
Participants will receive the 3-step Workout for Life program given by their physical therapy or occupational therapy providers. The program includes single-joint and multiple joint progressive resistance exercise and activities of daily living exercise training. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and lower extremity. During the activities of daily living exercise, participants will practice activities of daily living that they experience difficulty. The intervention volume, duration, and frequency will be modified to enhance practicality in a home health care setting over the implementation phase. In addition to the 3-Step Workout for Life, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-care items from the Outcome and Assessment Information Set (OASIS)
Time Frame: Change from admission to discharge which is a period of about two months
The self-care items are selected from the OASIS. OASIS is a comprehensive assessment to collect information in home health Medicare patients. The self-care items evaluate the degree of independence in seven activities: eating, oral hygiene, toileting hygiene, upper body dressing, lower body dressing, shower/bathe, and putting on/removing footwear. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). The home health care provider scores the patient based on information obtained from observation and interview. If an activity was not attempted, the reason would be documented (for example, the patient refused, not applicable because the patient did not perform this activity prior to the current illness, not attempted due to environmental limitations, medication conditions, or safety concerns). A ratio score will be computed to adjust for items that are not attempted.
Change from admission to discharge which is a period of about two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility items from the Outcome and Assessment Information Set (OASIS)
Time Frame: Change from admission to discharge which is a period of about two months

The mobility items are selected from the OASIS. The mobility items evaluate the degree of independence in the following activities: roll left and right, sit to lying, lying to sitting on side of the bed, sit to stand, chair/bed-to-chair transfer, toilet transfer, car transfer, walk 10 feet, walk 50 feet with two turns, walk 150 feet, walking 10 feet on uneven surfaces, 1 step (curb), 4 steps, 12 steps, picking up an object from the floor, wheel (use a wheelchair or scooter) 50 feet with two turns, & wheel 150 feet.

Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). The home health care provider scores the patient based on information obtained from observation and interview. If an activity was not attempted, the reason would be documented. A ratio score will be computed to adjust for items that are not attempted.

Change from admission to discharge which is a period of about two months
EuroQoL (EQ-5D-5L)
Time Frame: Change from admission to discharge which is a period of about two months
EuroQoL is a self-reported, health-related, quality of life questionnaire. It measures the quality of life on 5 domains, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 5-level scale, with a higher level indicates a better outcome.
Change from admission to discharge which is a period of about two months
Activity Measure Post Acute Care (AM-PAC): Home Care Short Form
Time Frame: Change from admission to discharge which is a period of about two months
AM-PAC home care short form is a patient-report outcome measure. It assesses patients' degree of difficulty doing daily activities, basic mobility, and functional cognition tasks (e.g., remember to take medications). A higher level indicates a better outcome.
Change from admission to discharge which is a period of about two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chiung-ju Liu, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Actual)

April 3, 2023

Study Completion (Actual)

June 5, 2023

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB202001011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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