Clinical trial NCT02114879: Enhanced Medical Rehabilitation in Older Adults
Official title: Enhanced Medical Rehabilitation in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disabling Medical Events
Disabled
Depression
Keywords: Physical Therapy
Occupational Therapy
Rehabilitation
Older adults
Depression
Physical Functioning
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2014-04-15
Enrollment: 229
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an effective treatment for older adults after disabling medical events.

Detailed description: The intervention involves physical and occupational therapy for patients who have been admitted to a skilled nursing facility for therapy following a disabling medical event.

Participants in this study will be randomly assigned to receive either Enhanced or standard of care therapy, meaning they will either receive their PT (Physical Therapy)\& OT(Occupational Therapy) from therapists who have been specially trained in the study intervention or from therapists with normal training. Participants will be assessed at baseline, 30, 60, and 90 days after baseline, and at the date of their discharge from the skilled nursing facility.

Eligibility criteria: Inclusion Criteria:

* 65 and older
* Admitted to a skilled nursing facility for post-acute care from PT and OT for 2 weeks or more.

Exclusion Criteria:

* Language, visual or hearing barriers to participation
* Medical illness preventing study participation or accurate data collection
* Moderate-severe dementia (demonstrated by chart diagnosis and/or short blessed score greater than 13)
* Progressive neurological condition such that recovery of function is not feasible
* Patient did not have the ability to walk prior to hospitalization (e.g. paraplegic)
* Schizophrenia or other chronic or current psychotic disorder.

Primary outcomes:
measure: Change in Barthel Index Score
timeFrame: Baseline and Discharge, an average of 24 days.
Secondary outcomes:
measure: Gait Speed (Determined by 4 or 10 Meter Walk Test)
timeFrame: Discharge, an average of 24 days after baseline.
measure: Distance Ambulated in 6-Minute Walk Test
timeFrame: Discharge, an average of 24 days after baseline.
measure: Self-reported Barthel Index
timeFrame: 30, 60, and 90 Days Post Admission to the SNF
measure: Discharge Disposition
timeFrame: Discharge, an average of 24 days after baseline.
measure: Rehospitalizations
timeFrame: Days 30, 60, and 90 post admission to a SNF as well as at Discharge
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Extended Care
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Alexian Brothers Sherbrooke Village
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Eric Lenze, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bland MD, Birkenmeier RL, Barco P, Lenard E, Lang CE, Lenze EJ. Enhanced Medical Rehabilitation: Effectiveness of a clinical training model. NeuroRehabilitation. 2016 Oct 14;39(4):481-498. doi: 10.3233/NRE-161380.
citation: Ercal B, Rodebaugh TL, Bland MD, Barco P, Lenard E, Lang CE, Miller JP, Yingling M, Lenze EJ. Executive Function Moderates Functional Outcomes of Engagement Strategies During Rehabilitation in Older Adults. Am J Phys Med Rehabil. 2021 Jul 1;100(7):635-642. doi: 10.1097/PHM.0000000000001739.
citation: Lenze EJ, Lenard E, Bland M, Barco P, Miller JP, Yingling M, Lang CE, Morrow-Howell N, Baum CM, Binder EF, Rodebaugh TL. Effect of Enhanced Medical Rehabilitation on Functional Recovery in Older Adults Receiving Skilled Nursing Care After Acute Rehabilitation: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jul 3;2(7):e198199. doi: 10.1001/jamanetworkopen.2019.8199.