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Clinical Trials/NCT04709783
NCT04709783TerminatedNot Applicable

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

University of Florida1 site in 1 country10 target enrollmentStarted: May 26, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
10
Locations
1
Primary Endpoint
Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care

Study Overview

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 aim is to evaluate the implementation-related clinical and patient outcomes.

Detailed Description

Medicare beneficiaries admitted to home health agencies are often in 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 therapy and occupational therapy practitioners 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 aim is to evaluate the implementation-related clinical and patient outcomes.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Implementation Arm

Experimental

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

Intervention: 3-Step Workout for Life (Other)

Outcomes

Primary Outcomes

Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care

Time Frame: Discharge, on average 2 months

The self-care measure is from the OASIS. It evaluates the degree of independence in seven activities: eating, oral hygiene, toileting hygiene, upper body dressing, lower body dressing, showering/bathing, and putting on/removing footwear. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). A ratio score is calculated as the sum of attempted activity scores divided by the maximal total score of attempted activities. For example, if the participant is dependent on all six self-care activities, the ratio score of this participant is 0.17 (= 7\*1/7\*6). The ratio score of OASIS self-care ranges from 0.17 (totally dependent on all self-care activities) to 1 (totally independent of all self-care activities). A higher ratio score means a higher ability to perform self-care.

Secondary Outcomes

  • Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility(Discharge, on average 2 months)
  • EuroQoL (European Quality of Life)(Discharge, on average 2 months)
  • Activity Measure of Post-Acute Care-Home Health Version(Discharge, on average 2 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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