Clinical trial NCT02905370: Progressing Home Health Rehabilitation for Older Adults
Official title: Progressing Home Health Rehabilitation Paradigms for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Physical Deconditioning
Keywords: Home Health
Rehabilitation
High Intensity
Hospital Associated Deconditioning
Functional Mobility
Physical Function
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Arcadia University
First posted: 2016-09-19
Enrollment: 353
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study explores the effects of a progressive, multi-component intervention following a stay in the hospital or rehabilitation facility. The purpose of this research study is to compare a multi-component intervention (higher intensity exercise, nutritional supplementation, and greater emphasis on functionally enhanced care transitions) with usual care physical therapy.

Detailed description: Declines in physical function as a result of acute illness are strongly and independently associated with a number of adverse health events for older adults. Home Health (HH) physical therapy may be the ideal venue for addressing these declines in physical function because around 3 million older adults receive HH services following discharge from acute or post-acute facilities. However, as currently structured, HH care does not appear to adequately restore function, as evidenced by poor long-term outcomes and high rates of hospital readmission. Diminished physical function has been particularly implicated as a risk factor for re-hospitalization --older adults with lower levels of ambulatory activity are 6 times more likely to be re-hospitalized than those with greater ambulatory activity. A more intensive approach to HH physical therapy for older adults has great potential to maximize physical function and reduce hospital readmissions. Therefore, the investigators have developed a high intensity home-based, progressive, interdisciplinary, multi-component (PMC) intervention that directly addresses the functional deficits seen after hospitalization. This intervention will include intensive rehabilitation, a care transitions program, and daily protein supplementation. The investigators will conduct a two-arm, randomized clinical trial (RCT) of 200 participants admitted to HH from an acute or post-acute facility. Participants will receive either 1) an intensive, PMC intervention using resistance exercise and evidenced-based motor control training to improve physical function, along with nutritional supplementation and emphasis on functionally enhanced care transitions or 2) usual care (UC) physical therapy. The primary goal of this investigation is to determine if PMC intervention, initiated upon admission to HH, improves physical function, as measured by performance and self-report assessments, more than UC physical therapy. The investigators will also examine the effects on fatigue, balance confidence, and activities of daily living. In an exploratory analysis, the effects of the PMC intervention on re-hospitalization rates, nursing home placement, emergency room visits, and falls after discharge from the acute care hospital will also be examined. All outcomes will be examined at baseline, 30, 60 (primary endpoint), 90 and 180 days. If successful in improving patient function and decreasing re-hospitalization rates, PMC intervention holds potential for future health care cost savings.

Eligibility criteria: Inclusion Criteria:

1. 65 years of age and older
2. Referred to home care physical therapy following acute medical deconditioning
3. Have at least 3 comorbid conditions including those listed below:

   * Chronic Obstructive Pulmonary Disease
   * Gastrointestinal Bleed
   * Urinary Tract Infection
   * Pneumonia
   * Chronic ulcerative wounds
   * Diabetes
   * Hypertension
   * Depression/mental health
   * Irritable Bowel Syndrome
   * Hernia
   * Post-op pancreatic surgery
   * Osteoporosis/OA/RA/Gout
   * Heart Disease
   * Hypercholesterolemia
   * Peripheral Arterial Disease
   * Spinal Stenosis
   * Dehydration
   * Syncope
   * Atrial fibrillation
   * Hypo/Hyperthyroid
   * Renal Failure (no dialysis)
   * Post-op bowel surgery
   * Congestive Heart Failure
4. Be ambulatory without human assistance prior to hospitalization
5. Be English-speaking

Exclusion Criteria: (one or more):

1. Acute lower extremity fracture with weight-bearing restriction
2. "Elective" joint replacement surgery
3. Lower extremity amputation
4. Acute cardiac surgery
5. Terminal illness
6. Active cancer treatment in which exercise is contraindicated
7. Deep vein thrombosis/pulmonary embolus (DVT/PE)
8. Recent stroke (within 1 yr)
9. Score of \<20 on SLUMS (as of 08.16.2018, revised to exclusion #14)
10. Inability to ambulate 10 feet without human assistance at time of hospital discharge
11. Gait Speed \<0.3m/s or \>1.0 m/s
12. Progressive neurodegenerative diagnosis (e.g. Parkinson's, MS, ALS)
13. Use of illegal substances
14. Clinical discretion of study physician to exclude patients who are determined to be unsafe and/or inappropriate to participate in high intensity rehabilitation as defined by the inclusion/exclusion criteria
15. Active involvement of Adult Protection Services
16. Current dialysis treatment
17. Prisoners or those on probation or other alternative sentencing

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change in SPPB from baseline to 60 days post randomization
Secondary outcomes:
measure: Modified Physical Performance Test (mPPT)
timeFrame: Change in mPPT from baseline to 60 days post randomization
measure: Fast walking speed (4MW)
timeFrame: Change in 4MW from baseline to 60 days post randomization
measure: ActivPAL
timeFrame: Change in physical activity from baseline to 60 days post randomization
measure: Falls Efficacy Scale-International
timeFrame: Change in Falls Efficacy Scale-International from baseline to 60 days post randomization
measure: Fatigue Severity Scale (FSS)
timeFrame: Change in FSS from baseline to 60 days post randomization
measure: Patient Activation Measure (PAM)
timeFrame: Change in PAM from baseline to 60 days post randomization
measure: Grip Strength
timeFrame: Change in Grip Strength from baseline to 60 days post randomization
Other outcomes:
measure: Falls, Emergency Department visits, nursing home days, hospitalizations
timeFrame: Quantification of falls, ED visits, nursing home days, and hospitalizations at 30, 60, 90, and 180 days post randomization
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer E Stevens-Lapsley, MPT, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Falvey JR, Mangione KK, Nordon-Craft A, Cumbler E, Burrows KL, Forster JE, Stevens-Lapsley JE. Progressive Multicomponent Intervention for Older Adults in Home Health Settings Following Acute Hospitalization: Randomized Clinical Trial Protocol. Phys Ther. 2019 Sep 1;99(9):1141-1149. doi: 10.1093/ptj/pzz069.