NCT02114879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

July 29, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 7, 2020

Completed
Last Updated

July 7, 2020

Status Verified

June 1, 2020

Enrollment Period

4 years

First QC Date

April 2, 2014

Results QC Date

May 18, 2020

Last Update Submit

June 23, 2020

Conditions

Disabling Medical EventsDisabledDepression

Keywords

Physical TherapyOccupational TherapyRehabilitationOlder adultsDepressionPhysical Functioning

Outcome Measures

Primary Outcomes (1)

  • Change in Barthel Index Score

    Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.

    Baseline and Discharge, an average of 24 days.

Secondary Outcomes (5)

  • Gait Speed (Determined by 4 or 10 Meter Walk Test)

    Discharge, an average of 24 days after baseline.

  • Distance Ambulated in 6-Minute Walk Test

    Discharge, an average of 24 days after baseline.

  • Self-reported Barthel Index

    30, 60, and 90 Days Post Admission to the SNF

  • Discharge Disposition

    Discharge, an average of 24 days after baseline.

  • Rehospitalizations

    Days 30, 60, and 90 post admission to a SNF as well as at Discharge

Study Arms (2)

Standard of Care Rehabilitation

ACTIVE COMPARATOR
Behavioral: Standard of Care Rehabilitation

Enhanced Medical Rehabilitation

EXPERIMENTAL
Behavioral: Enhanced Medical Rehabilitation

Interventions

Enhanced Medical RehabilitationBEHAVIORAL

Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.

Enhanced Medical Rehabilitation
Standard of Care RehabilitationBEHAVIORAL

Daily PT/OT provided by therapists not trained in the treatment intervention.

Standard of Care Rehabilitation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Barnes-Jewish Extended Care

St Louis, Missouri, 63105, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Alexian Brothers Sherbrooke Village

St Louis, Missouri, 63125, United States

Location

Related Publications (3)

  • 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.

    PMID: 27689608BACKGROUND

  • 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.

    PMID: 34131093DERIVED

  • 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.

    PMID: 31365113DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Emily Lenard
Organization
Washington University
lenarde@wustl.edu
314-747-5706

Study Officials

  • Eric Lenze, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 15, 2014

Study Start

July 29, 2014

Primary Completion

July 13, 2018

Study Completion

July 13, 2018

Last Updated

July 7, 2020

Results First Posted

July 7, 2020

Record last verified: 2020-06

Locations

US(3)