Disability or Chronic Disease Leading to Disablement, Frailty
Conditions
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.
Interventions
Participants will receive the modified 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. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and/or 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 exercise, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery.
Sponsors
American Occupational Therapy Foundation
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from two offices of a local home health agency. The home health therapy staff screened and referred eligible home health patients between April 2022 and March 2023. The first eligible participant was enrolled on May 26, 2022, and the last was enrolled in February 2023.
Pre-assignment details
Of 10 enrolled patients, all received the modified 3-Step Workout for Life program.
Participants by arm
| Arm | Count |
|---|---|
| Implementation Arm Participants will receive the modified 3-Step Workout for Life program and other rehabilitation services based on the plan of care.
3-Step Workout for Life: Participants will receive the modified 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. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and/or 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 exercise, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Implementation Arm |
|---|---|
| Activity Measure of Post-Acute Care-Home Health Version Applied Cognitive Domain | 44.35 T-scale score STANDARD_DEVIATION 6.92 |
| Activity Measure of Post-Acute Care-Home Health Version Basic Mobility Domain | 50.15 T-scale score STANDARD_DEVIATION 6.52 |
| Activity Measure of Post-Acute Care-Home Health Version Daily Activity Domain | 49.53 T-scale score STANDARD_DEVIATION 9.35 |
| Age, Continuous | 76.8 Years STANDARD_DEVIATION 6.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| European Quality of Life 5 Dimensions EQ-5D-5L | .49 units on a scale STANDARD_DEVIATION 0.27 |
| European Quality of Life 5 Dimensions EQ-VA | 57 units on a scale STANDARD_DEVIATION 29.08 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Ratio OASIS (Outcome and Assessment Information Set): Self-care and mobility Mobility | .63 Ratio STANDARD_DEVIATION 0.1 |
| Ratio OASIS (Outcome and Assessment Information Set): Self-care and mobility Self-care | .65 Ratio STANDARD_DEVIATION 0.08 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 6 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care
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.
Time frame: Discharge, on average 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implementation Arm | Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care | 0.93 Ratio | Standard Deviation 0.14 |
p-value: 0.01Wilcoxon (Mann-Whitney)
Secondary
Activity Measure of Post-Acute Care-Home Health Version
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.
Time frame: Discharge, on average 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implementation Arm | Activity Measure of Post-Acute Care-Home Health Version | Basic Mobility Domain | 55.77 T-scale score | Standard Deviation 7.64 |
| Implementation Arm | Activity Measure of Post-Acute Care-Home Health Version | Daily Activity Domain | 54.96 T-scale score | Standard Deviation 7.22 |
| Implementation Arm | Activity Measure of Post-Acute Care-Home Health Version | Applied Cognitive Domain | 45.44 T-scale score | Standard Deviation 5.98 |
p-value: 0.02Wilcoxon (Mann-Whitney)
Secondary
EuroQoL (European Quality of Life)
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.
Time frame: Discharge, on average 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implementation Arm | EuroQoL (European Quality of Life) | EQ-5D-5L | 0.68 score on a scale | Standard Deviation 0.22 |
| Implementation Arm | EuroQoL (European Quality of Life) | EQ-VAS | 64.5 score on a scale | Standard Deviation 22.29 |
p-value: 0.07Wilcoxon (Mann-Whitney)
Secondary
Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility
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.
Time frame: Discharge, on average 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Implementation Arm | Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility | 0.89 Ratio | Standard Deviation 0.19 |
p-value: 0.01Wilcoxon (Mann-Whitney)