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Implementing 3-Step Workout for Life in Home Health

Primary Purpose

Frailty, Disability or Chronic Disease Leading to Disablement

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3-Step Workout for Life
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implementation Arm

Arm Description

Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care.

Outcomes

Primary Outcome Measures

Self-care items from the Outcome and Assessment Information Set (OASIS)
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.

Secondary Outcome Measures

Mobility items from the Outcome and Assessment Information Set (OASIS)
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.
EuroQoL (EQ-5D-5L)
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.
Activity Measure Post Acute Care (AM-PAC): Home Care Short Form
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.

Full Information

First Posted
January 7, 2021
Last Updated
July 11, 2023
Sponsor
University of Florida
Collaborators
American Occupational Therapy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04709783
Brief Title
Implementing 3-Step Workout for Life in Home Health
Official Title
Implementing 3-Step Workout for Life to Improve ADL Outcome in Home Health
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
June 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
American Occupational Therapy Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Disability or Chronic Disease Leading to Disablement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implementation Arm
Arm Type
Experimental
Arm Description
Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care.
Intervention Type
Other
Intervention Name(s)
3-Step Workout for Life
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-care items from the Outcome and Assessment Information Set (OASIS)
Description
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.
Time Frame
Change from admission to discharge which is a period of about two months
Secondary Outcome Measure Information:
Title
Mobility items from the Outcome and Assessment Information Set (OASIS)
Description
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.
Time Frame
Change from admission to discharge which is a period of about two months
Title
EuroQoL (EQ-5D-5L)
Description
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.
Time Frame
Change from admission to discharge which is a period of about two months
Title
Activity Measure Post Acute Care (AM-PAC): Home Care Short Form
Description
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.
Time Frame
Change from admission to discharge which is a period of about two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiung-ju Liu, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26583695
Citation
Liu CJ, Jones LY, Formyduval A RM, Clark DO. Task-Oriented Exercise to Reduce Activities of Daily Living Disability in Vulnerable Older Adults: A Feasibility Study of the 3-Step Workout for Life. J Aging Phys Act. 2016 Jul;24(3):384-92. doi: 10.1123/japa.2015-0070. Epub 2015 Nov 19.
Results Reference
background
PubMed Identifier
28769559
Citation
Liu CJ, Xu H, Keith NR, Clark DO. Promoting ADL independence in vulnerable, community-dwelling older adults: a pilot RCT comparing 3-Step Workout for Life versus resistance exercise. Clin Interv Aging. 2017 Jul 19;12:1141-1149. doi: 10.2147/CIA.S136678. eCollection 2017.
Results Reference
background
PubMed Identifier
32073464
Citation
Liu CJ, Donovan J, Wolford CL. Feasibility of staff-led 3-Step Workout for Life to reduce late-life activities of daily living disability: a community-based translational study. Int J Rehabil Res. 2020 Jun;43(2):141-147. doi: 10.1097/MRR.0000000000000396.
Results Reference
background

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Implementing 3-Step Workout for Life in Home Health

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