- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03032341
Mobility Assessment Using Surrogates in Elderly Participants (MAT)
Study Overview
Status
Conditions
Detailed Description
According to the U.S. Census Bureau projections, the number of persons 65 years of age or older will increase from roughly 40 million in the year 2010, to 88.5 million in 2050, a net increase of 121%. During this same time period, the number of persons 85 years of age or older will increase by 227%; accounting for nearly 5% of the U.S. population. Mobility and functional status are important predictors of outcomes in this rapidly growing elderly population. It has shown that walking speed and physical function, measured by Short Physical Performance Battery (SPPB) are predictors of mortality in community-dwelling older men and women. It was also reported that gait speed predicts incident disability in community dwelling elderly subjects. In our prior study, we have demonstrated that, mobility, assessed using an animated video clip based assessment tool, Mobility Assessment Tool-short form (MAT-sf) predicts postoperative complications, length of stay and nursing home placement in elderly patients (>69) who were undergoing elective surgery that requires overnight hospitalization and more clinical practices use physical function and mobility as a tool to predict outcomes.
However, these assessments are not always readily available, especially in clinical situations when acute illnesses or injuries occurred without any chance to assess the baseline status, such as acute myocardial infract, rapidly progressing sepsis or catastrophic trauma. In these cases, patients are often sedated, intubated, have altered mental status, or too unstable to perform even non-invasive testing. Although some clinicians or researchers feel that surrogate can accurately assess the patients' baseline physical function and mobility status, it was never been tested.
The investigators hypothesize that mobility assessment done on surrogates, using MAT-sf will have high compatibility with the assessment done on elderly patients. Surrogates are defined as a person who spends >2 hours a day or 8 hours a week with the patient and accompany the patient to most of their medical appointments. The investigators will test the hypothesis at the Preoperative Assessment Clinic since this clinic sees high volume of elderly patients and patients at this clinic tend to have their caregiver with them during the appointments.
Investigators will enroll 20 patients in poor mobility group (MAT-sf < 51.38 in men and <45.61 in women), 20 patients into the mid-mobility group (51.38< MAT-sf≤65.5 in men and 45.61≤MAT-sf<54.02) and 20 patients into the high mobility group (MAT-sf>65.5 in men and MAT-sf>54.02 in women) for a total of 60 patients and one surrogate per patient for a total of 120 unique participants.
To assess mobility, participants will be instructed on the use of the Mobility Assessment Tool-short form (MAT-sf). The MAT-sf is a 10-item computer based assessment of mobility using animated video clips. The 10 items in the MAT-sf cover a broad range of functioning. The items include walking on level ground, a slow jog, walking outdoors on uneven terrain, walking up a ramp with and without using a handrail, stepping over hurdles, ascending and descending stairs with and without the use of a handrail, and climbing stairs while carrying bags. The items were previously selected based on individual response and information curves derived from Item Response Theory. Each item is accompanied by an animated video clip together with the responses for that question (number of minutes, number of times, yes/no). The test will be performed on an I-PAD and scores will be saved to an exportable file. The time required to do the test with instructions from the examiner is expected to be no longer than 5 minutes. While the patient is completing the MAT-sf assessment, the surrogate will be directed to a separate room to complete MAT-sf for the patient ("Do you think Mr ** can climb up this hill?) , so there is no interaction between the patient and the surrogate during the assessment. Investigators will measure the compatibility between patients-surrogates mobility using MAT-sf and will also assess the stability of surrogate MAT-sf.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 70 years and older being seen at the PAC;
- Patients who have caregiver or family who meet the criteria for surrogate as above;
- Patients scheduled for elective surgical procedures.
Exclusion Criteria:
- Patients who have a language barrier which will prohibit them from understanding the questionnaire and directions connected to the use of the MAT-sf;
- Patients who are not able to sign their own surgical consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Patient group
20 patient in poor mobility group (MAT-sf < 51.38 in men and <45.61 in women), mid-mobility group (51.38<
MAT-sf≤65.5 in men and 45.61≤MAT-sf<54.02) and high mobility group (MAT-sf>65.5 in men and MAT-sf>54.02 in women) for a total of 60 patients.
|
Surrogate group
A family member/caregiver that attends visits with the patient and will be asked to answer the Mobility Assessment Test questionnaire on behalf of the patient at the initial visit and the follow up visit 1-14 days later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in MAT-sf score between patients and surrogates
Time Frame: 1-14 days
|
Investigators will measure the compatibility between patients-surrogates mobility using MAT-sf.
|
1-14 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sunghye Kim, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00040417
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mobility Limitation
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR)RecruitingOlder Adults | Limitation, MobilityCanada
-
University of North GeorgiaUnknownRelaxation; Joint | Limitation, Mobility | Relaxation; LumbosacralUnited States
-
Centre de Recherche de l'Institut Universitaire...Completed
-
Saint Joseph Mercy Health SystemTerminatedMobility LimitationsUnited States
-
US Department of Veterans AffairsCompletedAging | Mobility LimitationsUnited States
-
National Institute on Aging (NIA)Spaulding Rehabilitation Hospital PM&RCompletedAging | Mobility LimitationsUnited States
-
Klinik ValensState Secretariat for Education Research and Innovation, Switzerland; Office...CompletedGeriatric Disorder | Mobility LimitationsSwitzerland
-
University of MalayaCompletedPressure Injury | Limitation, MobilityMalaysia
-
McGill UniversityRichard and Edith Strauss Foundation of CanadaCompletedSeniors With Mobility LimitationsCanada
-
Chang Gung Memorial HospitalCompleted