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REACH Pilot Study (Rehabilitation Enhancing Aging Through Connected Health)

Maintaining Physical Independence in Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02580409
Acronym
REACH
Enrollment
75
Registered
2015-10-20
Start date
2015-01-31
Completion date
2017-07-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mobility Limitation

Keywords

health care utilization, health care costs

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALExercise 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.

Sponsors

Boston University
CollaboratorOTHER
Brandeis University
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Spaulding Rehabilitation Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
Yes

Inclusion criteria

1. Ages 65-95 years 2. Able to understand and communicate in English 3. Difficulty or task modification with walking ½ mile (6 blocks) or climbing one flight of stairs 4. Ability to continuously walk 400 m in less than 15 minutes without stopping for more than a minute at a time, sitting, leaning, or the help of another person 5. Lives in a zip code within 10 mile radius of Spaulding Cambridge Facility 6. Baseline Short Physical Performance Battery (SPPB) scores from 3-12 with \<20% of SPPB scores in the 11-12 range

Exclusion criteria

1. Presence of a terminal disease (e.g. receiving hospice services, metastatic cancer) 2. Major surgery or Myocardial Infarction in the last 6 months 3. Planned major surgery (e.g. joint replacement) 4. Planned move from the Boston area within 1.5 years 5. Mini-mental state exam (MMSE) score \<20 6. Major medical problems interfering with safe and successful testing (examples may include: history hip replacement with recurrent dislocation, uncontrolled hypertension, use of supplemental oxygen)

Design outcomes

Primary

MeasureTime frameDescription
Change in Late Life Function and Disability Index (Function Domain Only)Assessed at baseline visit and 12 months after baseline visit (1 year visit)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..

Other

MeasureTime frameDescription
Change in the Short Physical Performance Battery (SPPB)Assessed at screen visit, 6 month assessment after baseline visit and 12 months after baseline visit (1 year visit)The Short Physical Performance Battery (SPPB) is an objective physical performance assessment tool for evaluating lower extremity functioning in older persons.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
68
Total68

Baseline characteristics

CharacteristicSingle-arm Studies
Age, Continuous77.4 years
STANDARD_DEVIATION 6
BMI27.5 Kg/m^2
STANDARD_DEVIATION 4.39
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
7 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
White
55 Participants
Sex: Female, Male
Female
37 Participants
Sex: Female, Male
Male
31 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 68
other
Total, other adverse events
0 / 68
serious
Total, serious adverse events
0 / 68

Outcome results

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..

Time frame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)

ArmMeasureValue (MEAN)Dispersion
Single-arm StudiesChange in Late Life Function and Disability Index (Function Domain Only)1.67 units on a scaleStandard Error 0.55
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.

Time frame: Assessed at screen visit, 6 month assessment after baseline visit and 12 months after baseline visit (1 year visit)

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026