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Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility

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ClinicalTrials.gov Identifier: NCT04300413
Recruitment Status : Suspended (On hold due to COVID-19 outbreak)
First Posted : March 9, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

During a hospital stay, older adults often become physically deconditioned and lose their ability to perform activities of daily living. Afterwards, they commonly require rehabilitation in a skilled nursing facility to regain independence. Even at discharge, however, many older adults are still far below their pre-hospitalization level of function making them at risk for adverse events such as falls, rehospitalizations, and loss of independence. Two reasons for inadequate outcomes may include that 1) physical and occupational therapy interventions are delivered at too low an intensity to incur substantial physiological gains, and 2) residents are largely sedentary outside of structured therapy time. These two problems represent critical targets for interventions that optimize care in skilled nursing facilities. Therefore, the investigators designed High-Intensity Rehabilitation + Mobility (HeRo), a patient-centered approach to skilled nursing facility care that incorporates a combination of high-intensity (i.e. high resistance, low repetition) functionally-based resistance training along with a structured mobility program outside of therapy time.

HeRo includes: 1) a team approach to patient-centered care; 2) a physical activity intervention that incorporates principals of behavioral economics, which uses incentives, goal setting, and gamification to optimize patient engagement and health outcomes and 3) a challenging, high-intensity rehabilitation intervention that pushes patients to expand their limits. The investigators expect that HeRo will improve physical function and physical activity while reducing sedentary time for older adults in the skilled nursing facility. The study team will assess the feasibility and acceptability of HeRo for multiple stakeholders including patients, physical and occupational therapists, nursing staff, and administration. This research will improve patient care in the skilled nursing facility environment, getting older adults on a fast track to developing independence after a hospital stay.


Condition or disease Intervention/treatment Phase
Physical Disability Other: High-Intensity Rehabilitation plus Mobility (HeRo) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single arm study but will use two historical cohorts as comparison groups to assess outcomes: 1) usual care and 2) high-intensity, functionally based resistance training alone. The historical cohorts were included in a previous study (Clinical Trials Registry identifier: E2193-P). This design will include independent cohorts of patients within a single SNF, using the facility as its own control. This design optimally controls for facility-level variables that vary widely between SNFs and may influence care delivery, such as staffing levels, staff experience, and productivity standards.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility
Actual Study Start Date : February 16, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-Intensity Rehabilitation plus Mobility (HeRo)
The HeRo group will receive a behavior-change intervention based in the principals of behavioral economics to improve mobility. Physical and occupational therapists have been trained to deliver a high-intensity, functional intervention as the standard of care in this skilled nursing facility.
Other: High-Intensity Rehabilitation plus Mobility (HeRo)
Progressive, high-intensity strengthening and functional intervention coupled with structured mobility based in principals of behavioral economics.




Primary Outcome Measures :
  1. Gait Speed [ Time Frame: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days ]
    Time it takes to walk 4 meters (meters per second)


Secondary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days ]
    Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests


Other Outcome Measures:
  1. Patient Satisfaction Survey [ Time Frame: At date of discharge after their stay in the Skilled Nursing Facility, (approximately 21 days after admission). ]
    8 question survey on patient satisfaction, scoring each question on a 1-10 scale (1=not at all and 10=extremely)

  2. Physical Activity (upright time) [ Time Frame: Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days). ]
    Percent waking hours spent upright measured using ActivPAL devices

  3. Physical Activity (sedentary time) [ Time Frame: Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days). ]
    Time spent in sedentary bouts measured using ActivPAL devices

  4. Treatment fidelity [ Time Frame: At least 2 observations per provider per year throughout duration of study (approximately 2 years), 2 additional observations scheduled if compliance is <80% on objective fidelity checklist. ]
    Provider intervention compliance with high-intensity rehabilitation (PT and OT) and mobility (nursing staff) using a fidelity checklist



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults over 50 who are admitted to a skilled nursing facility following hospitalization
  • Qualify to receive at least physical therapy services
  • Ambulatory prior to hospitalization

Exclusion Criteria:

  1. Patients with neurological disorders such as acute stroke or acute traumatic brain injury
  2. Patients on hospice care
  3. Patient with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription):

    1. Recent unstable fracture
    2. Advanced congestive heart failure
    3. Bone metastasis sites
    4. Tumors in strengthening target areas
    5. Acute Illness
    6. Recent myocardial infarction (within 3-6 weeks)
    7. Weight bearing restrictions on graft or fracture sites
    8. Exposed tendon or muscle
    9. Absence of pedal pulses
    10. Presence of fistula
    11. Platelet levels <50,000/μL
  4. Weight-bearing precautions and inability to ambulate prior to hospitalization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300413


Locations
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United States, Colorado
Veterans Community Living Center at Fitzsimmons
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Jennifer Stevens-Lapsley, PT, PhD University of Colorado School of Medicine
Publications:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04300413    
Other Study ID Numbers: 19-2490
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No