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| Name | Class |
|---|---|
| Boston University | OTHER |
| Brandeis University | OTHER |
| Massachusetts General Hospital | OTHER |
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Rehabilitation Enhancing Aging through Connected Health, REACH, is designed to evaluate the benefits of a novel rehabilitative care program on physical function utilizing mobile health technology to deliver patient centered care more efficiently and health care utilization after one year of follow up.
Rehabilitation Enhancing Aging through Connected Health, REACH, is designed to evaluate the benefits of a novel rehabilitative care program on physical function utilizing mobile health technology to deliver patient centered care more efficiently and health care utilization after one year of follow up. Study staff will recruit 76 community dwelling older adult primary care patients. The same procedures that were approved by the IRB for the Boston RISE cohort study. This study was initiated in 2009 and its data is publicly archived. will be used for REACH recruitment, screening and enrollment of potential participants. This process will be centered at Spaulding Cambridge Outpatient Clinic (SCOC). Potential participants will be contacted and a brief phone screen will be conducted. Eligible and interested participants will be scheduled for the consent/screen visit. If the participant consents, the study staff will administer three tests to determine final eligibility for study involvement. These include: Mini Mental Status Exam, the Short Physical Performance Battery (SPPB) and the Long Distance Corridor Walk.
Qualified participants will complete all baseline and 1-year assessments at SCOC. The assessments include: the Late Life Function and Disability Index (LLFDI), Hopkins Verbal Learning Test, Trail Making, Digit Symbol Substitution Test, Katz Comorbidity, depression (PHQ-9), Activities Specific Balance Scale, Barriers Specific Self-Efficacy Scale, Computer Attitude Scale, McGill Pain Map, Brief Pain Inventory, Figure 8 walk test, grip strength testing, single leg press strength and speed testing, ankle/knee ROM, the trunk extensor endurance test and stair climb power test.
The exercise/technology training with a licensed physical therapist will consist of 8-10 (with the possibility of up to 16 sessions) clinic or home visits interspersed over a 9-month period and will take place after baseline at one of two locations per choice of participant: SCOC or BU Center for Neurorehabilitation. During the clinic/home visits, the assigned exercises are video recorded using the Wellpepper clinician version housed on an iPad mini. During and after the in-person visits, the PTs will remotely monitor exercise adherence, provide feedback, progress the exercise program and answer participants' questions using the chat feature of the exercise app. PT support will be tapered over the course of this 9-month period as the participants become more successful at integrating exercise into their lives using the provided technology. Over the final 3 months of the study, participants will continue to perform exercises independently with reduced PT involvement. PT support will be available through the chat feature if participants have questions or concerns.
Participants will be contacted at quarterly intervals and asked to self-report recent falls, hospitalizations, ER visits and PT (outside of their participation in this study). At 6 months the LLFDI will be administered over the phone. In addition, the PT will perform these performance based assessments during a clinic visit: SPPB, ankle/knee ROM, trunk extensor endurance test and the stair climb power test.
Collaborators at Brandeis University will access CMS claims data for all participants during the year of participation and for an additional six months after study participation ends to evaluate health care utilization and health care costs after 1-year of follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm studies | Other | Behavioral Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Investigators are proposing an innovative rehabilitative care program for older primary care patients at risk for mobility decline. The program targets newly identified risk factors for mobility decline and utilizes mobile health technology to deliver patient centered care more efficiently. Study participants will receive exercise instruction with a licensed physical therapist for an average of 8-10 training sessions, with the possibility of up to 16 sessions. some at home and some in the clinic. The exercise training sessions will focus on improving mobility, balance and ability to get up from a chair with the use of an exercise application (Wellpepper) being used on a study issued iPad. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Late Life Function and Disability Index (Function Domain Only) | The Late-Life Function & Disability Instrument (Late-Life FDI) is a self-report evaluative outcome instrument for community-dwelling older adults. It is designed to assess and be responsive to meaningful change in two distinct outcomes: function and disability. It is possible to measure one without the other. For this study, only the functional domain will be used. Functional limitations pertain to limitations in a person's ability to do discrete actions or activities. This domain is scaled between 0-100 with higher scores reflecting better mobility. The outcome measure is presented as a coefficient of change within a regression model evaluating baseline and follow up values of the outcome.. | Assessed at baseline visit and 12 months after baseline visit (1 year visit) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Short Physical Performance Battery (SPPB) | The Short Physical Performance Battery (SPPB) is an objective physical performance assessment tool for evaluating lower extremity functioning in older persons. | Assessed at screen visit, 6 month assessment after baseline visit and 12 months after baseline visit (1 year visit) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan F Bean, MD, MS, MPH | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital Cambridge | Cambridge | Massachusetts | 02138 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31152705 | Derived | Bean JF, Brown L, DeAngelis TR, Ellis T, Kumar VSS, Latham NK, Lawler D, Ni M, Perloff J. The Rehabilitation Enhancing Aging Through Connected Health Prehabilitation Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):1999-2005. doi: 10.1016/j.apmr.2019.04.015. Epub 2019 May 29. | |
| 28931377 | Derived | Ni M, Brown LG, Lawler D, Ellis TD, Deangelis T, Latham NK, Perloff J, Atlas SJ, Percac-Lima S, Bean JF. The rehabilitation enhancing aging through connected health (REACH) study: study protocol for a quasi-experimental clinical trial. BMC Geriatr. 2017 Sep 20;17(1):221. doi: 10.1186/s12877-017-0618-x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-arm Studies | Behavioral Intervention Exercise Intervention: Investigators are proposing an innovative rehabilitative care program for older primary care patients at risk for mobility decline. The program targets newly identified risk factors for mobility decline and utilizes mobile health technology to deliver patient centered care more efficiently. Study participants will receive exercise instruction with a licensed physical therapist for an average of 8-10 training sessions, with the possibility of up to 16 sessions. some at home and some in the clinic. The exercise training sessions will focus on improving mobility, balance and ability to get up from a chair with the use of an exercise application (Wellpepper) being used on a study issued iPad. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-arm Studies | Behavioral Intervention Exercise Intervention: Investigators are proposing an innovative rehabilitative care program for older primary care patients at risk for mobility decline. The program targets newly identified risk factors for mobility decline and utilizes mobile health technology to deliver patient centered care more efficiently. Study participants will receive exercise instruction with a licensed physical therapist for an average of 8-10 training sessions, with the possibility of up to 16 sessions. some at home and some in the clinic. The exercise training sessions will focus on improving mobility, balance and ability to get up from a chair with the use of an exercise application (Wellpepper) being used on a study issued iPad. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Late Life Function and Disability Index (Function Domain Only) | The Late-Life Function & Disability Instrument (Late-Life FDI) is a self-report evaluative outcome instrument for community-dwelling older adults. It is designed to assess and be responsive to meaningful change in two distinct outcomes: function and disability. It is possible to measure one without the other. For this study, only the functional domain will be used. Functional limitations pertain to limitations in a person's ability to do discrete actions or activities. This domain is scaled between 0-100 with higher scores reflecting better mobility. The outcome measure is presented as a coefficient of change within a regression model evaluating baseline and follow up values of the outcome.. | Posted | Mean | Standard Error | units on a scale | Assessed at baseline visit and 12 months after baseline visit (1 year visit) |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-arm Studies | Behavioral Intervention Exercise Intervention: Investigators are proposing an innovative rehabilitative care program for older primary care patients at risk for mobility decline. The program targets newly identified risk factors for mobility decline and utilizes mobile health technology to deliver patient centered care more efficiently. Study participants will receive exercise instruction with a licensed physical therapist for an average of 8-10 training sessions, with the possibility of up to 16 sessions. some at home and some in the clinic. The exercise training sessions will focus on improving mobility, balance and ability to get up from a chair with the use of an exercise application (Wellpepper) being used on a study issued iPad. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Bean | Spaulding Rehabilitation Hospital | 617 952 6813 | jfbean@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2015 | Sep 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | Kg/m^2 |
|
|
|
| Other Pre-specified | Change in the Short Physical Performance Battery (SPPB) | The Short Physical Performance Battery (SPPB) is an objective physical performance assessment tool for evaluating lower extremity functioning in older persons. | Not Posted | Assessed at screen visit, 6 month assessment after baseline visit and 12 months after baseline visit (1 year visit) | Participants |
| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
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| D001519 | Behavior |