Trial Outcomes & Findings for REACH Pilot Study (Rehabilitation Enhancing Aging Through Connected Health) (NCT NCT02580409)
NCT ID: NCT02580409
Last Updated: 2025-12-15
Results Overview
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..
COMPLETED
NA
75 participants
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
2025-12-15
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
REACH Pilot Study (Rehabilitation Enhancing Aging Through Connected Health)
Baseline characteristics by cohort
| Measure |
Single-arm Studies
n=68 Participants
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.
|
|---|---|
|
Age, Continuous
|
77.4 years
STANDARD_DEVIATION 6.0 • n=6009 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=6009 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=6009 Participants
|
|
BMI
|
27.5 Kg/m^2
STANDARD_DEVIATION 4.39 • n=6009 Participants
|
PRIMARY outcome
Timeframe: 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..
Outcome measures
| Measure |
Single-arm Studies
n=68 Participants
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.
|
|---|---|
|
Change in Late Life Function and Disability Index (Function Domain Only)
|
1.67 units on a scale
Standard Error .55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Single-arm Studies
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place