Implementing 3-Step Workout for Life in Home Health

Not Applicable

Terminated

Conditions: Disability or Chronic Disease Leading to Disablement
Frailty

Interventions: Other: 3-Step Workout for Life

Registration Number: NCT04709783

Lead Sponsor: University of Florida

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care	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 Outcome Measures

Name	Time	Method
Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility	Discharge, on average 2 months	The mobility measure from OASIS evaluates the degree of independence in 17 mobility activities, such as roll left and right or sit to lying. 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 17 mobility activities, the ratio score of this participant is 0.17= 0.06 (17\1/17\6). The ratio score of OASIS mobility ranges from 0.17 (totally dependent on all mobility activities) to 1 (totally independent of all mobility activities). A higher ratio score means a higher ability to perform mobility tasks independently.
EuroQoL (European Quality of Life)	Discharge, on average 2 months	EuroQoL is a self-reported quality of life measure. The EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. An index score ranges from -0.59 (worst health) to 1 (best health). The EQ VAS (EuroQol_visual analogue scale) records the patient's self-rated health on a vertical visual analog scale ranging from 0 to 100. A higher score indicates better self-perceived health status.
Activity Measure of Post-Acute Care-Home Health Version	Discharge, on average 2 months	The measure evaluates the degree of difficulty in performing tasks in three domains: basic mobility, daily activities, and cognitive tasks. The raw score under each domain is then converted to a standardized T-scale score. According to the testing manual, the T-scale score range for basic mobility is from 30.36 to 70.71, for daily activities is from 22.45 to 61.92, and for applied cognition is from 9.89 to 49.40. A higher score indicates a better mobility, daily activities, or functional cognition performance. The manual does not provide information on clinically relevant thresholds or mean/SD of the T-scale.