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Completed

NCT Number: NCT05411393

Synergizing Home Health Rehabilitation Therapy

The objective of this project is to pilot test an ADL (activities of daily living)-enhanced program as an adjuvant therapy to usual home health rehabilitation to improve patient outcomes. The project will compare the ADL-enhanced program plus usual care with usual care using an RCT design in home health patients.

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Key information

Conditions

Frailty Activities of Daily Living Frail Elderly Functional Status Health Services for the Aged Home Health Care Occupational Therapy Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Functional Performance Rehabilitation Treatment Outcome

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

Regaining the ability to take care of oneself after an illness or medical episode is critical for home health patients to maintain independent living at home. An ADL-enhanced program may augment the effect of home health rehabilitation therapy to support patients' self-care outcomes. Patients will be randomly assigned to two groups: one will receive the ADL-enhanced program with usual home health care, and the other will receive usual home health care. Researchers will compare outcomes in self-care activities and physical performance between the two groups to determine the effect of the ADL-enhanced program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients are eligible if they

  • are 65 years of age over older
  • are Medicare beneficiaries
  • are referred for skilled rehabilitation services at the partnered home health agency
  • have three or more comorbidities

Patients are ineligible if they have

  • acute fractures with surgical or weight-bearing restrictions,
  • elective joint replacement surgery
  • lower-extremity amputation
  • active treatment for cancer diagnosis
  • ongoing dialysis treatment
  • acute cardiac surgery,
  • acute stroke or a major neurologic disorder limiting motor movements
  • terminal stage of congestive heart failure
  • a referral to hospice care
  • severe cognitive deficits limiting verbal communication.

Treatment and study plan

ADL-enhanced program

Other

The ADL-enhanced program consists of six home visits delivered by a study occupational therapy staff. The study therapy staff will use the compensatory approach and the restorative approach during the visits to enhance patients' activity engagement. The compensatory approach uses strategies to reduce the activity demand to make every task easier. For example, using the sitting position to perform self-care tasks. The restorative approach uses strategies to increase the demand of the task to increase the patient's functional capacity. For example, carrying a full-load laundry basket versus an empty laundry basket.

Usual home health rehabilitation therapy

Other

Usual home health rehabilitation therapy is prescribed by the home health agency. It often includes occupational therapy and physical therapy delivered in one to three home visits per week for one to two months.

Primary outcomes

  1. The Motor Skills Score From the Assessment of Motor and Process Skills

    Time frame: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)

    The Motor Skills score is a subscale in the Assessment of Motor and Process Skills, which evaluates the degree of motor performance when an individual performs a challenging daily activity. The score range of the subscale ranges from -3 to +4. A higher score indicates better motor performance.

Secondary outcomes

  1. Activity Measure Post Acute Care: Home Care Short Form

    Time frame: Baseline, post-intervention (approximately 2 months from baseline), 1-month follow-up (approximately 3 months from baseline), 3-month follow-up (approximately 5 months from baseline)

    Activity Measure Post Acute Care: Home Care Short Form is a self-reported outcome measure of functional independence to live in the community. The reported T-score is a standardized score derived from raw responses, scaled to have a mean of 50 and a standard deviation of 10 in the reference population. The Basic Mobility subscale evaluates indoor and outdoor mobility; higher scores indicate better mobility performance. The Daily Activity subscale measures the ability to perform self-care tasks at home; higher scores reflect better performance in daily activities.

  2. Box and Block Test

    Time frame: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)

    The test measures motor coordination of the upper extremity through moving small wooden blocks within one minute. Each hand was tested separately. A higher score indicates better hand function.

  3. Jebsen Hand Function Test

    Time frame: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)

    The test measures upper extremity function by recording the time it takes to complete seven daily tasks, such as writing or picking up small, common objects. A longer time to complete all tasks indicates poor hand function.

  4. Timed-Up-and-Go Test

    Time frame: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)

    The test measures functional mobility by recording the time it takes to get up from a chair, walk, and return to the chair. A higher score indicates poor functional mobility.

  5. Short Physical Performance Battery

    Time frame: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)

    The test measures balance, walking speed and chair stand. The score range is from 0 to 12. A higher score indicates better physical performance of the lower extremity.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Synergizing Home Health Rehabilitation Therapy to Optimize Patients' Activities of Daily Living

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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