Disabling Medical EventsEMRNCT02114879
Enhanced Medical Rehabilitation in Older Adults
A study testing Enhanced Medical Rehabilitation in people with Disabling Medical Events and Disabled, run by Washington University School of Medicine at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Disabling Medical Events, Disabled, Depression
- What is being tested?
- Enhanced Medical Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jul 2014to 13 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 and older
- Admitted to a skilled nursing facility for post-acute care from PT and OT for 2 weeks or more.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Barnes-Jewish Extended Care
St Louis, Missouri, 63105
Washington University School of Medicine
St Louis, Missouri, 63110
Alexian Brothers Sherbrooke Village
St Louis, Missouri, 63125
About this study
The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an effective treatment for older adults after disabling medical events.
Read the 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.
- Conditions
- Disabling Medical Events, Disabled, Depression
- Being tested
- Enhanced Medical Rehabilitation, Standard of Care Rehabilitation
- Keywords
- Physical Therapy, Occupational Therapy, Rehabilitation, Older adults, Depression, Physical Functioning
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Medical RehabilitationBehavioural
Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
Standard of Care RehabilitationBehavioural
Daily PT/OT provided by therapists not trained in the treatment intervention.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Rehabilitation | Active comparator | Not described Receives: Behavioral: Standard of Care Rehabilitation |
| Enhanced Medical Rehabilitation | Experimental | Not described Receives: Behavioral: Enhanced Medical Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Barthel Index Score
Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.
Measured: Baseline and Discharge, an average of 24 days.
Secondary outcomes (5)
Gait Speed (Determined by 4 or 10 Meter Walk Test)
Meters walked per second.
Measured: Discharge, an average of 24 days after baseline.
Distance Ambulated in 6-Minute Walk Test
Feet walked during 6 minute interval.
Measured: Discharge, an average of 24 days after baseline.
Self-reported Barthel Index
Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. Conducted as a self-report at timepoints where patient was not in an institutional setting.
Measured: 30, 60, and 90 Days Post Admission to the SNF
Discharge Disposition
Number of participants discharged from skilled nursing facility to home
Measured: Discharge, an average of 24 days after baseline.
Rehospitalizations
Assesses whether the participant was readmitted to the hospital.
Measured: Days 30, 60, and 90 post admission to a SNF as well as at Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study start29 Jul 2014
- Primary completion13 Jul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disabling Medical EventsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Eric Lenze, Washington University School of Medicine
- Investigators
- Eric Lenze, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114879
- Sponsor's protocol ID
- R01 MH099011A1
- Other IDs
- 5R01MH099011-02
- Acronym
- EMR
- Status last verified
- Jun 2020
- First submitted
- 2 Apr 2014
- Last updated
- 7 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27689608Ercal 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.
PubMed 34131093Lenze 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.
PubMed 31365113
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Medical Rehabilitation in Older Adults
- ClinicalTrials.gov ID
- NCT02114879
- Acronym / sponsor ID
- EMR / R01 MH099011A1
- Conditions
- Disabling Medical Events, Disabled, Depression
- Keywords
- Physical Therapy, Occupational Therapy, Rehabilitation, Older adults, Depression, Physical Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 29 Jul 2014 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Rehabilitation | Active comparator | Behavioral: Standard of Care Rehabilitation |
| Enhanced Medical Rehabilitation | Experimental | Behavioral: Enhanced Medical Rehabilitation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 and older
- Admitted to a skilled nursing facility for post-acute care from PT and OT for 2 weeks or more.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Medical RehabilitationDaily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity. | Behavioural | Enhanced Medical Rehabilitation |
| Standard of Care RehabilitationDaily PT/OT provided by therapists not trained in the treatment intervention. | Behavioural | Standard of Care Rehabilitation |
Primary outcome
Change in Barthel Index Score
Time frame: Baseline and Discharge, an average of 24 days.
Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.
5 secondary outcomes
Gait Speed (Determined by 4 or 10 Meter Walk Test)
Time frame: Discharge, an average of 24 days after baseline.
Distance Ambulated in 6-Minute Walk Test
Time frame: Discharge, an average of 24 days after baseline.
Self-reported Barthel Index
Time frame: 30, 60, and 90 Days Post Admission to the SNF
Discharge Disposition
Time frame: Discharge, an average of 24 days after baseline.
Rehospitalizations
Time frame: Days 30, 60, and 90 post admission to a SNF as well as at Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27689608Bland 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.
- Derived from this study: PubMed 34131093Ercal 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.
- Derived from this study: PubMed 31365113Lenze 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Lenze, MD principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Medical Rehabilitation in people with Disabling Medical Events and Disabled, run by Washington University School of Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Barthel Index Score (time frame: Baseline and Discharge, an average of 24 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02114879, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.