Maintaining Physical Independence in Older Adults
Phase: NA
Conditions: Mobility Limitation
Sponsor: Spaulding Rehabilitation Hospital

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I. 
BACKGROUND AND SIGNIFICANCE 
 
a. Historical background 
 
For older adults, a decline in mobility skills is a signal event, identifying higher risk for disability and 
increased healthcare utilization. Whatever the cause, the decline or loss of the ability to walk safely, climb 
stairs or get up from a chair (collectively termed “mobility skills”) are signal events. Without detection and 
intervention, deterioration of mobility skills can begin an inexorable downward spiral leading to 
dependency, morbidity, increased health care utilization and mortality.1,2 On the basis of 20 years of 
research in this area, we know that mobility limitations are largely preventable and there are opportunities 
for improving outcomes and access to quality focused care in both healthy and chronically ill older adults. It 
is estimated that without establishment of new care paradigms specific to treating mobility limitations that 
these problems alone will add an estimated $42 billion to health care costs by 2040.2 Currently there is no 
drug therapy for mobility limitations and the most efficacious treatment is rehabilitative care. 
 
Health care and health care financing in this country are largely predicated on a medical model which 
prioritizes acute, disease-specific conditions, and on the provision of medical and surgical interventions. 
However, it has been demonstrated that for older adults, following disease specific guidelines is a major 
cause of adverse health outcomes and increased costs of care.3 In contrast, rehabilitative care treats the 
functional consequences of diseases and conditions, directly addressing individual needs using a 
comprehensive integrated approach to preserve and improve physical function. Access to high quality 
rehabilitation services is a major gap in our fragmented healthcare system. There are no established models 
that focus on treating and preventing mobility decline or that can be scaled to the varied populations of 
older adults residing in the US.1,4  
 
b. Previous pre-clinical or clinical studies leading up to, and supporting the proposed research 
 
We have developed a paradigmatically novel program within the Partner’s HealthCare System that produces 
clinically meaningful improvements in physical functioning among mobility limited older adults. A video 
describing the patient care experience is available online (http://www.spauldingrehab.org/conditions-and-
treatments/live-long-walk-strong). This program is unique in a variety of ways. It uses five brief questions, 
administered in the context of a primary care visit and identifies individuals at increased risk for falls, 
mobility decline and disability. Also, it targets the most important impairments contributing to mobility 
decline, employs cognitive behavioral strategies, and motivates life style changes that maintain the 
functional gains. The benefits are observed over six to eight weeks and with only one to two visits per week.  
The magnitude of improvement observed (2.3 units on the Short Physical Performance Battery) exceeds 
thresholds of clinically meaningful improvement.5,6 Other work from our clinical laboratory at Spaulding 
Rehabilitation Hospital has guided the content of this clinical program. We have been conducting a 
longitudinal cohort study of community dwelling older adults served by the primary care practices of 
Massachusetts General Hospital and Brigham and Women’s Hospital. This NIH-funded study, known as the 
Boston Rehabilitative Impairment Study of the Elderly (Boston RISE), was developed to identify attributes 
that are most responsible for mobility decline and disability after 2 years of follow up.7 Boston RISE 

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specifically focuses on attributes that when impaired can be treated with rehabilitative care. Boston RISE has 
identified four attributes--limb strength, limb speed, range of motion and trunk muscle endurance--as being 
the attributes that are predictive of decline in both basic and advanced mobility skills among older adults.8 
All four of these attributes are targeted within our proposed rehabilitative care program, REACH 
(Rehabilitation Enhancing Aging through Connected Health). 
The pilot work of our Boston University collaborators has successfully used multiple approaches to extend 
the benefits of Physical Therapy (PT) by providing behavioral strategies to increase exercise motivation; 
remote monitoring by the PT; adaptation and progression of the exercises; and individualized videos and 
instructions of each exercise.9 In a three-month RCT of sedentary older adults with Parkinson disease, we 
compared the efficacy of physical therapy delivered with the mobile health platform to usual delivery of 
physical therapy. The mobile health platform used was an application called Wellpepper accessed with an 
iPad. Hereafter, this technology will be referred to as Wellpepper. After a three-month period of exercising a 
minimum of three days per week, the subjects who received physical therapy delivered using Wellpepper 
experienced greater improvements in exercise self-efficacy, walking endurance and time spent performing 
moderate intensity exercise compared to standard PT. Adherence to the exercise program was 81% in the 
Wellpepper group and 57% in the standard care condition.  This gap is expected to widen with observations 
over longer periods of time.  Results from our satisfaction survey reveal that all participants in the 
Wellpepper condition would like to continue the program and would recommend it to others.   This 
innovative approach to rehabilitation using mobile health technology bridges the transition from outpatient 
care through home care and finally to independent adoption and maintenance of healthy behaviors.  
We have also achieved positive long-term functional outcomes with a novel intervention applied among a 
particularly vulnerable population of mobility limited elders: those recovering from hip fracture.10 In these 
patients, we tested a simple home exercise program after standard post-operative care. With three to four 
home-based Physical Therapy visits and five subsequent monthly phone calls that provide cognitive-
behavioral strategies focused on maintaining physical activity, we observe clinically greater improvements in 
physical functioning compared to controls at six months.  This intervention utilized DVD players and videos 
to help ensure participation and compliance with the physical activity program. The physical activity 
program was evidence-based and specifically targeted the physical needs of patients recovering from hip 
fracture. Notably the clinical improvements observed were even maintained at nine months, three months 
after the intervention was discontinued, suggesting that patients can adopt these healthy behaviors. 
Methodological features of this study among hip fracture patients have informed the design of the proposed 
intervention. 
In addition to this previous work developing our intervention, our colleagues at Brandeis University’s Heller 
School have extensive experience in evaluating health care utilization and cost especially as it relates to the 
care of vulnerable older adults. The team has, for example, evaluated the feasibility and cost effectiveness 
of CMS's Lifestyle Modification Program Demonstration, a program focused on lifestyle changes around diet, 
exercise, and stress reduction on cardiovascular disease. The study included 589 participants and 3000 
matched controls and found low cost cardiac rehabilitation to be the most cost effect model. The Brandeis 
team has evaluated many other CMS demonstrations including an expansion of low vision rehabilitation 
services, expanded coverage for chiropractic services and adult day care. 

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c. Rationale behind the proposed research, and potential benefits to patients and/or society 
 
While the importance of clinical programs targeting mobility has been highlighted in a recent JAMA editorial, 
no programs exist that can be scaled to serve the needs of older adults across the US. For example, a large 
multicenter trial recently published in JAMA, known as the LIFE study, demonstrated improvements in 
mobility outcomes after 2.6 years of follow up.11 While these findings are very promising, the approach has 
distinct drawbacks, limiting its ability to be scaled for large numbers of older adults. It required attendance 
by participants in group-based exercise classes two times per week for a long duration of time (2.6 years). In 
addition, the program was based on a model of care (use of exercise trainers) that is not currently funded by 
Medicare.  An innovative approach is needed to optimize outcomes, minimize healthcare expenditures and 
facilitate retention of gains made in the skilled setting. 
As part of healthcare reform, Medicare is now mandating that primary care physicians perform an annual 
wellness visit that prioritizes preventative care strategies. Recognizing that screening of mobility skills is well 
suited for this sort of wellness visit, our study is designed to evaluate the benefits of rehabilitative care as a 
treatment within a preventative care paradigm. Primary care physicians do not typically prescribe 
rehabilitative care in this context, and thus our program is not considered an example of standard practice. 
In Table 1, we describe some of the unique and innovative aspects of our rehabilitative care paradigm in 
contrast to the existing standard of care commonly prescribed for patients with mobility complaints. 
In addition, traditional Medicare models of reimbursement are often focused on limited, episodic care over a 
shorter period of time and reimbursed in distinct provider settings. The model we are proposing combines 
provider settings (outpatient and home care) to allow us to observe how the participant performs the 
recommended exercise program in their home environment and offer modifications to maximize safety and 
benefit within the unique limitations of their physical space. In addition, we are proposing fewer overall visits 
spread out over a longer period of time (12 months) and augmented with mobile health technology to keep 
the participant engaged as well as provide opportunities for progression or modification of the exercise 
program as needed.  The table below highlights some important differences related to the traditional 
Medicare model of skilled care and the new paradigm we are exploring. 
Table 1 
Current traditional Medicare Model 
Proposed New REACH Model 
Little to no planned contact with patients between 
skilled rehab visits 
Regular contact via phone and the iPAD via the 
Wellpepper application 
Significant variability in the quality of visual 
aids/training for home exercise performance 
High quality videos of the patients performing the 
assigned exercises with auditory feedback 
Limited course of care over a relatively short period 
of time (episodic) 
Care extended over a longer period of time with 
decreased frequency as patients assume more of 
their care independently-augmented by the 
Wellpepper app 
Impairment focused interventional strategy 
targeting limited deficits 
Function focused interventional strategy targeting 
comprehensive  aspects of mobility  
Behavioral change strategies are infrequently 
utilized in care for older adults 
Incorporation of behavioral change strategies to 
encourage long term maintenance and adoption of 
exercise behaviors 

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Care typically delivered in one setting per episode of 
care 
Mixture of home/outpatient visits to optimize safe, 
effective exercise performance and highlight 
environmental concerns 
Limited ability to progress the exercise type and 
intensity as care episodes are of shorter duration 
Extending the course of care over a longer period of 
time enabling program progression/modification/ as 
appropriate and able 
 
The proposed pilot study will evaluate the benefit of this care program on physical function and health care 
utilization. The resulting findings have the potential to change how mobility care is provided and thus to 
prevent mobility decline in older adults and broadly impact national healthcare reform initiatives. 
II. 
SPECIFIC AIMS 
 
For older adults, a decline in mobility skills is a signal event, identifying higher risk for disability and 
increased healthcare utilization. Based upon the collective research and clinical experience of our 
multidisciplinary team, we 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. The program is 
consistent with Medicare funded services, but uses a number of innovations such as mobile health 
technology to demonstrate the potential for long term benefit. This proof of concept quasi-experimental 
trial will evaluate the benefit of this unconventional care program on physical function and health care 
utilization after one year of follow up.  
 
Our project will evaluate three main objectives: 
1. In comparison to matched controls derived from the Boston RISE cohort study, we will evaluate 
the benefit of our mobility care program on physical function among 76 older adults at risk for 
mobility decline after one year of follow up. 
Hypothesis: In comparison to controls, participants in our mobility care program will have 
significantly greater improvements in physical function after one year of follow up. 
2. In comparison to matched controls derived from Medicare claims data, we will evaluate the 
impact of our mobility care program on health care utilization after one year of follow up. 
Hypothesis: In comparison to controls, participants in our mobility care program will have 
significantly fewer hospitalizations and ED visits after one year of follow up. 
3. In comparison to matched controls derived from Medicare claims data, we will evaluate the 
impact of our mobility care program on health care costs after one year of follow up. 
 Hypothesis: In comparison to controls and after accounting for the estimated per patient costs 
of our intervention, participants in our mobility care program will have significantly lower 
healthcare costs after one year of follow up. 
 
 
 

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III. 
SUBJECT SELECTION 
 
This proof of concept quasi-experimental pilot study will evaluate the benefit of a novel rehabilitative care 
program on physical function and health care utilization after one year of follow up. We will recruit 76 
community dwelling older adult primary care patients. 
 
 Inclusion criteria: 
1. Age ³ 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) 
 
Recruitment procedures will follow the same methodology utilized within the previously IRB approved 
Boston RISE cohort study.7 Prior to contacting any potential participants, Dr. Bean and his staff will convene 
educational sessions with clinicians from participating primary care practices at Mass General Hospital in 
order to familiarize their staff with the study.  To facilitate continued and regular support with recruitment 
throughout the course of the study, Dr. Steven Atlas and his research coordinator at MGH primary care are 
collaborators. They will facilitate recruitment from primary care clinics within the MGH healthcare systems. 
 
The target of the primary care-based recruitment will be adults aged 65 to 95 receiving primary care within 
clinics of the MGH, representing a diverse population of older adults. Recruitment will not specifically target 
primary care patients who have been referred to physical therapy for treatment of a specific condition that 
they manifest such as a knee injury. Rather, it is targeting older adults in need of preventative care, which is 
a novel focus for rehabilitation. Potential participants will be identified through the MGH Primary Care 
Operations Improvement (PCOI) loyalty cohort (Protocol # 2004P002796) and direct identification by 
cooperating primary care providers. This patient database (Primary Care Provider Loyalty Cohort, IRB: 
2004P002796) is stored on a password-protected server at the MGH Laboratory of Computer Science. At all 
times, data and results will be protected in conformance with the confidentiality policies of the 
Massachusetts General Hospital, the security procedures of the Laboratory of Computer Science, and the 

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applicable policies of Partners Information Systems. Upon receipt of IRB approval, this patient database will 
be securely imported into the established REDCap tracking database by Dr. Steven Atlas and his team at 
MGH. 
 
Once in REDCap, this recruitment database will be accessed initially to provide MGH primary care physicians 
with the names of their patients so that they can corroborate an individual’s eligibility and designate those 
to whom they feel that letters should be sent. Study ID’s will be assigned to the remaining potential 
participants and recruitment letters will be mailed. We may access the recruitment database during the 
course of the study for the following purposes: 
 
• 
To contact participants for payment and study-related issues 
• 
To inform design for future studies that may result from this study 
• 
For mandated reporting from the funding agency 
 
The PCOI loyalty cohort is an IRB approved validated algorithm which identifies and links all patients within 
MGH primary care practices to a specific primary care provider or, if unable to link to a specific provider, to a 
specific primary care practice. A list of potentially eligible participants will be generated by the PCOI loyalty 
cohort and organized by provider. The list will also assign a unique study ID number to each potentially 
eligible participant.  Study staff will provide MGH primary care physicians with a patient list via email or in-
person. They will eliminate any of their patients who they do not feel are appropriate for this research 
study. 
 
Initial contact with subjects will be conducted using identical methods to those of other IRB approved 
primary care-based studies at MGH. Potential subjects will be sent a letter signed by their primary care 
physician (PCP) and the Principal Investigator (PI) describing the study and offering them the opportunity to 
state their disinterest in being contacted. Disinterested individuals can indicate their wishes by checking a 
box and returning a pre paid postcard or contacting project staff directly. If the potentially eligible primary 
care patient does not return the postcard or contact us within two weeks of receiving the letter, study staff 
may contact that individual, asking about their interest in participation. Interested individuals will have their 
initial eligibility determined through completion of a 1-minute telephone questionnaire designed explicitly 
for the identification of individuals at risk for mobility decline (those who respond that they have difficulty 
with or task modification in walking a ½ mile and/or climbing one flight of stairs) and through questions 
addressing exclusion criteria.  If it is felt that a personal visit at the primary care office may increase the 
likelihood that people will agree to participate, we will arrange to conduct group educational sessions at 
primary care practices.  
 
Once someone appears eligible and expresses interest, they will be promptly scheduled for a baseline 
screening.   Based on our prior experience utilizing this recruitment strategy among older adults with 
functional limitations, we estimate that we will need to send letters to 209 potential subjects from which 
127 people (61%) will allow contact by our staff and meet basic eligibility criteria.  Of the 127, we expect 76 
people (62% of eligible) to complete the baseline visit. If recruitment is slow, measures can be taken to 
increase the rate.  For example, if we perceive that minorities are more difficult to recruit, we can put more 

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effort into recruitment at selected clinics with higher minority concentrations. If there are particular areas 
that have lower cooperation rates, we will make additional efforts to work more closely with primary care 
staff at those respective clinics in order to enhance recruitment. Additionally, we want to ensure that we 
recruit individuals with a broad range of physical functioning. Typically, exercise and rehab studies tend to 
have no difficulty in recruiting higher functioning individuals.  Thus, we will ensure that no more than 20% of 
individuals are higher functioning, scoring an 11 or 12 (out of 12) on the Short Physical Performance Battery. 
Thus, we will be monitoring baseline SPPB scores and once we have recruited 10% of cohort into either 
category of high SPPB performance, additional individuals scoring at this level will be excluded from the 
study. 
 
IV. 
SUBJECT ENROLLMENT 
The informed consent will be mailed or emailed to interested individuals ahead of the baseline screening 
visit. Any additional questions that arise in between the time of the phone screen and the first visit can be 
answered by telephone. The Research Coordinator or Physical Therapist will meet with potential 
participants in a private room at Spaulding Cambridge to review the consent form, review the iPad 
Information and Responsibility form, answer any questions and confirm understanding. The Principal 
Investigator will be on site or reachable by phone to answer any additional questions. The Research 
Coordinator/Physical Therapist will then obtain written consent. 
If the participant consents to participate, the study staff will administer three tests to determine the 
participant’s final eligibility for study involvement. These include: Mini Mental Status Exam,12 the Short 
Physical Performance Battery (SPPB)13 and the 400 meter walk test.14 Those eligible will have the choice of 
continuing with the baseline assessment during the screening visit or returning for the baseline assessment 
during a subsequent visit.  All baseline and one-year assessments (described below within study procedures) 
will occur at Spaulding Cambridge. Participants will undergo the initiation of the exercise/technology 
training with a licensed physical therapist at one of two locations: Spaulding Cambridge Outpatient Clinic 
(SCOC) or the Center for Neurorehabilitation at the College of Health and Rehabilitative Sciences, Sargent 
College, Boston University. Participants will choose their location based on geographical convenience 
initially until it is necessary to assign them in order to achieve equal participant numbers at each location.  
V. 
STUDY PROCEDURES 
Enrolled participants will complete in-person assessments at baseline and 12 months at SCOC. The main 
study outcome will be the Late Life Function and Disability Index (LLFDI).15 Additional assessments include: 
Hopkins Verbal Learning Test16, Trail Making (Parts A and B)17, Digit Symbol Substitution Test18, Katz 
Comorbidity Questionnaire19, depression (PHQ-9)20, Activities Specific Balance Scale (ABC)21, Barriers Specific 
Self-Efficacy Scale22, Computer Attitude Scale,23 McGill Pain Map,24 Brief Pain Inventory25, Figure 8 walk 
test,26 Grip Strength testing with a hand-held dynamometer(Jamar), 27 Single leg press strength and speed 
testing, 28 ankle/knee ROM, 29  the Trunk extensor endurance test30, 4-step stair climb and stair climb power 
test.31 All questionnaire completion will be done at a slow enough pace so as not to tire individuals. To 
minimize subject burden during the assessment visits, staff will provide ample time for breaks and resting 
between assessments. All physical performance tests will be initiated by a demonstration of technique and 

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an initial repetition/trial of minimal effort in order to ensure familiarity and safety with the procedures. If 
research staff deems a participant cannot perform a task safely, would be at risk for injury or could 
exacerbate an existing condition, then the participant will not perform that task. If adverse symptoms or 
potentially serious side effects develop during any of the testing, procedures will be terminated 
immediately. Participants may refuse any assessment. During the 12 month visit, assessments may be 
prioritized and the visit abbreviated based upon the corresponding needs and safety concerns of 
participants.  Study participants who report being unable to do in-person office visits at 12 months may be 
offered the option of having a home visit conducted by the physical therapist or research assistant. 
Additionally, those who are unable to do a home visit may be offered the option of doing a phone interview.   
At approximately 3 months, 6 months, and 9 months, study staff will contact participants over the phone to 
administer questions. Participants will be asked to self-report recent falls, hospitalizations, emergency room 
visits and prescribed physical therapy (*outside of the REACH intervention that is described in more detail 
below). During the 6 month phone call, study staff will also conduct the Late Life Function and Disability 
Index (LLFDI)15 over the phone. Since, the participants will still be participating in PT visits associated with 
the REACH intervention at the approximate 6 month time point the licensed physical therapist will perform 
the following performance based assessments during one of their clinic visits: SPPB13 and ankle/knee ROM29. 
Information regarding the participant’s performance will be shared with the participant for the purpose of: 
(1) providing feedback regarding functional performance changes, (2) enhancing participant motivation to 
continue to exercise and (3) promoting behavioral change for the adoption of a long term exercise habit. 
 

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Table 2: REACH Data Collection Time Table (*in addition to PT intervention) 
Assessment 
Estimated 
duration of 
testing 
(minutes) 
Screen 
 
Baseline 
 
3 Month 
(Phone) 
 
6 Month 
(in person 
& phone) 
 
9 Month 
(Phone) 
 
12 Month  
Informed Consent 
30 
X 
 
 
 
 
 
MMSE 
5 
X 
 
 
 
 
X 
SPPB 
10 
X 
 
 
 
X 
 
X 
 
Long Distance Corridor Walk 
 
15 
X 
 
 
 
 
X 
 
Demographic & Health History 
Questionnaire 
 
5 
  
 
X 
 
 
 
 
 
Technology Experience Survey  
2 
 
 
 
 
 
X 
Physical Activity Item 
1 
 
X 
 
 
 
 
Katz Comorbidity 
15 
 
 
X 
 
 
 
 
 
Height/Weight & Vitals 
5 
  
 
X 
 
 
 
 
X 
 
Cognitive Testing 
20-30 
  
 
 
 
 
 
Hopkins Verbal Learning Test 
  
 
 
 
 
 
Trail Making 
  
X 
 
 
 
X 
Digit Symbol Substitution Test 
  
 
 
 
 
 
 
PHQ-9  
 
5 
  
 
X 
 
 
 
 
X 
 
History of Falls/Hospitalizations/ER/PT 
 
5 
  
 
X 
 
X 
 
X 
 
X 
 
X 
 
Global measures of function & disability 
 
2 
  
 
X 
 
 
 
 
X 
 
LLFDI  
 
30 
  
 
X 
 
 
X 
 
 
X 
Self-efficacy 
 
 
 
 
 
 
 
ABC scale 
15 
 
 
X 
 
 
 
 
X 
Barriers Specific 
 
 
 
 
 
 
 
 
Brief Pain Inventory 
 
5 
 
 
X 
 
 
 
 
X 
 
McGill Pain Map 
 
5 
 
 
X 
 
 
 
 
X 
 
Computer attitude scale 
 
2 
 
 
X 
 
 
 
 
X 
 
Grip Strength 
 
5 
  
 
X 
 
 
 
 
X 
 
Figure 8 
 
5 
  
 
X 
 
 
 
 
X 
 
Trunk Extensor Endurance 
 
5 
  
 
X 
 
 
 
 
 
X 
 
Range of Motion 
 
10 
  
 
X 
 
 
X 
 
 
X 
 
Leg Strength/Power 
 
20 
  
 
X 
 
 
 
 
X 
Stair Climb 
5 
 
 
X 
 
 
 
 
 
X 
4-Step Stair Climb 
5 
 
 
X 
 
 
 
 
X 
Visit Total Time 
 
 
~ 1 hr 
 
~ 2.5- 3 hr 
 
5 min 
 
~ 1 hr 
 
5 min 
 
~ 3.5- 4 hr 
 

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Upon completion of the baseline assessment, participants will be assigned to either the Boston University or 
Spaulding Cambridge Outpatient Clinic training site to begin the REACH model of rehabilitative care. 
Participants will participate in an average of 8-10 clinic or home visits that can be increased up to 16 total 
visits as needed and interspersed over a 9-month period with a physical therapist licensed in MA. During the 
clinic/home visits, the assigned exercises are video recorded using the Wellpepper clinician version of the 
exercise application 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 Wellpepper application.  PT support will be tapered over the course 
of this nine-month period as the participants become more successful at integrating exercise into their lives.  
Over the final three months of the study (months 10-12), subjects will continue to use the iPAD and the 
Wellpepper application to perform their exercises independently. The PT will not initiate communication 
with the participants; however, PT support will be available through the chat feature if participants have 
questions or concerns. 
Participants are introduced to the Wellpepper iPad platform early in the intervention phase of the study to 
ensure they are adequately trained on proper use of the iPad and the exercise application. When the iPad is 
issued to the participant, their responsibilities will be reviewed again and they will be asked to sign a form 
indicating that they understand and agree with their responsibilities (see the submitted REACH iPad 
Information and Responsibility form). The participant will receive a copy of the form and the original form 
will be kept in a locked cabinet in the research office at the Cambridge study site. Each participant will 
understand that the iPad is to be returned upon treatment completion or early withdrawal. Participants will 
be told that there will be no financial consequences if the issued iPad is damaged, lost or stolen, but that 
they should handle the iPad carefully and keep it secured against theft.  
 
Home visits are interwoven among the clinic visits to foster integration of the exercise program into daily 
routines with the support and guidance of a physical therapist. Optimizing exercise performance and 
strategizing overcoming barriers to exercising to facilitate long-term engagement in exercise will be a 
primary focus of the home visits.   The specific number of visits and the location of the visits will be 
determined by the participant and the physical therapist.  
 
During the initial PT sessions, the exercises are recorded using the clinician version of the Wellpepper 
exercise application housed on an iPad mini.  These exercises are stored on the “cloud”.  The therapist 
downloads the participant version of the Wellpepper exercise app on an iPad mini that will be provided to 
each participant to take home.  Each participant is instructed in how to open the exercise application and is 
able to view him/herself performing a subset of exercises that were uploaded by the PT (see Figure 1). The 
visual illustrations are accompanied with an audio component consisting of directions and cues from the PT 
that are tailored to each participant to ensure optimal technique when performing each exercise.  The 
number of exercises prescribed at any one time is limited to 7 exercises as studies have shown that too 
many exercises contributes to poor adherence. 32 The participant views the video prior to performing each 
exercise and is able to replay or repeat as needed.  Participants are instructed to implement the exercise 
program 5x/week for 30 minutes each session. Participant progress will be monitored and the ideal is that 
they exercise five times per week and engage in a walking program. However, we understand that this may 

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not be feasible for all participants. Therapists will be working with each participant to achieve this goal. The 
Technology Experience Survey will be administered to each participant by the study PT about a month after 
being issued the iPad to assess initial response and experience with the technology component of the 
exercise intervention. 
 
 Following completion of each exercise, the participant inputs the number of sets and repetitions completed 
and the level of pain or difficulty experienced (Figure 1).  In addition, the participant can communicate with 
the PT using a chat feature to ask a question or seek clarification.  Participant’s exercise adherence is 
recorded and graphically displayed, allowing participants and the PT to track progress over the entire 
exercise program.  The Wellpepper platform uses notifications (i.e. automated prompts and reminders) to 
motivate participants to complete their exercise programs at pre-scheduled times.  Exercises are grouped 
according to degree of difficulty (bronze – easiest; silver – moderate; gold – most challenging level). 
Participants can view progress toward more challenging exercises and receive rewards (automated 
motivational messages) as they move from one level to the next. Each participant will practice using the 
application and performing the exercises over the course of the outpatient and home PT sessions.   
Daily Exercises            
  A video clip and instructions      
Communication back to the PT 
                              Figure 1. Screen shots of the mHealth Application, PT Intervention 
 
The PT will initiate and respond to each participant though the Wellpepper application over a 9 month 
period. The PT will view the dashboard remotely on the clinician version of the application to review each 
participant’s performance and progress.  In response to feedback from the participant regarding pain, level 
of difficulty and success, the PT will remove or add exercises.  The PT will also upload motivational video 
content.  These videos contain messages from the PT about the benefits of exercise. The PT also receives 
automated alerts when a participant leaves a message using the chat feature in addition to when 
participants have not performed their exercises for more than one week.  PT support will be tapered over 
the course of this nine month period as the patients become more successful at integrating exercise into 
their lives. During months 10-12, participants will continue to use the iPad and the Wellpepper application 
 
 
 

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to perform their exercises independently without PT initiated support. Participants will be able to contact 
the PT through the chat feature if questions or problems arise during the final 3 months of the study.   
 
Regarding home exercise compliance, the expectation is that the participant will comply with the assigned 
videotaped exercises, 5 days a week for 30 minutes each session throughout the duration of the 12 months 
that they are active in the study. Participants may exceed the recommendation if they so choose. The 
physical therapist will be monitoring participant home exercise compliance through the in-person visits and 
the Wellpepper App. While a 5 times per week exercise schedule is the ultimate goal, we understand that 
this may not be feasible for all participants or it may take time to work up to this frequency. In addition, we 
realize that illness or other events may interfere with regular exercise performance. Therapists will be 
working with each participant to help them achieve the 5 times per week goal. The PT will receive an alert 
when a participant has not performed their assigned exercises for more than one week. The PT will 
communicate with the participant by phone or through the Wellpepper App chat feature to determine the 
reason for non-compliance. Non-compliance with the assigned exercises will not be grounds for study 
dismal. We recognize that exercising once per week is better than not exercising at all. Our intent is to 
encourage increased exercise performance through the enhanced communication feature of the iPad and 
the Wellpepper app, not penalize a participant in any way for non-compliance.  
 
The exercises are based upon standard rehabilitative techniques advocated for older adults. They will 
address attributes known to impact mobility such as leg strength, leg speed, trunk muscle endurance, limb 
flexibility, postural stability and cardiovascular endurance.  Exercise specifics will target upright functional 
movements with progressive levels of difficulty and intensity with the goal of providing a safe, robust 
stimulus that is acceptable and most likely to produce improved function. A variety of exercises are included 
to guard against adaptation or boredom over the 12 month study. The exercises will utilize limited 
equipment and lend themselves to safe, independent performance in the home environment. See 
attachment, “Sample Exercises for REACH Study”. Each patient will be assigned up to seven exercises at any 
given time. Exercises will be progressed or modified in response to participant feedback. In addition, the 
participants will be instructed in a progressive walking program that will be monitored via participant report 
relative to the frequency and time spent in the activity. The uniqueness of this interventional protocol lies in 
the method of physical therapy delivery: 1) limited face to face treatment sessions spaced over a longer 
period of time 2) remote monitoring for an extended period 3) enhanced exercise performance with 
provision of videos/communications via the Wellpepper application.  
 
As mentioned in our “Background and Significance”, our collaborators at Brandeis have evaluated health 
care utilization in many studies, including cardiac and vision studies. They will utilize similar methodology 
and access the Medicare claims data for all of our participants. More details about their data access and 
management are provided later within the “Monitoring and Quality Assurance” section. The claims data 
requested will include the one year time period during which the participant is active in the study as well as 
the 6 months following their one-year assessment. The additional 6 months allows for an appropriate “run-
out” to account for the discrepancies between when health care utilization (such as an Emergency Room 
visit) occurs versus when the event appears in the claims data. The Heller School at Brandeis University has 
developed a comprehensive information security policy and built a secure data network to house sensitive 

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data, including Medicare claims. Brandeis has a long standing relationship with the Center for Medicaid and 
Medicare Services and houses a large volume of administrative claims that are used for a variety of 
evaluation and development activities. 
 
We will not be recruiting a control group, but selecting a matched group of participants from the Boston 
RISE cohort study as controls for aim 1, which focuses on functional outcome measures. The Boston RISE 
cohort study is a longitudinal cohort study evaluating mobility decline among older primary care patients. 
Boston RISE contains all of the primary and secondary outcome measures of the study. For outcomes 
utilizing Medicare Claims data, data is only available for a geographic region encompassing a minimum of 
250,000 individuals. Thus, for aims 2 and 3, our collaborators at Brandeis will also identify a second matched 
control group based upon scientifically relevant data elements, such as age, gender, race, chronic 
conditions, etc. 
 
VI. 
BIOSTATISTICAL ANAYLSIS 
 
This quasi-experimental study will use a difference-in-difference (D-in-D) approach to assess the impact of 
mHealth supported PT compared to treatment as usual. We will use a strong matching algorithm, such as 
exact matching on age, sex and the propensity to participate in treatment, to ensure comparability on 
observable characteristics between treatments and control group members. For this study the propensity 
score serves as a form of data reduction, taking many diagnostic flags and reducing them to a single 
covariate. The basic model estimates the effect of treatment on the change in outcome between baseline 
and follow-up: 𝑦"# = 𝛽&+𝛽'𝑡𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡" +𝛽.𝑝𝑜𝑠𝑡"# + 𝛽3𝑡𝑟𝑒𝑎𝑚𝑒𝑛𝑡" ∗𝑝𝑜𝑠𝑡"# + 𝛾𝑐𝑜𝑛𝑡𝑟𝑜𝑙𝑠"# + 𝛼" + 𝜀"# where 
𝑦"# is cost, 𝛾𝑐𝑜𝑛𝑡𝑟𝑜𝑙𝑠"# are patient socio-demographic characteristics and 𝑡𝑟𝑒𝑎𝑚𝑒𝑛𝑡" is a 0/1 variable 
indicating treatment status. 𝛽3 is the parameter of interest, capturing the joint effect of being in the 
treatment group at time 2. For the first study object, this model can be extended to include repeated 
measures of functional status over time. This is a proof of concept pilot study and thus we may not be 
powered to observe statistically significant differences among our outcomes between groups. However, the 
effect sizes will be utilized to inform the design of larger trials. For example, meaningful differences in the 
LLFDI have been published by our group and will help interpret the magnitude of treatment effects 
observed. 
 
VII. 
RISKS AND DISCOMFORTS 
 
Common risks and discomforts 
All of the proposed measures have been validated among older adults of varying health status. The staff has 
extensive experience conducting these measures safely among older adults with mobility problems. Many of 
the assessments for this study involve minimal risk to the participants such as questionnaires, measures of 
leg strength and power using a double leg press machine, measurement of core muscle weakness, 
performance of simple balance testing, standing up from a chair, walking eight feet, and balancing with feet 
in a tandem position.  Thus the risks are expected to be similar to those risks involved in participating in a 
physical therapy program, standing, stair climbing, walking, and activities of daily living.  The balance and 
walk tests could potentially result in a fall, but the protocol includes careful personal monitoring during the 

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testing.  Lastly, there is the rare possibility that the Long Distance Corridor Walk could precipitate 
cardiovascular symptoms. A research assistant (RA) will prepare the course, provide instructions and walk 
with the participant. In addition, the RA will take vitals before and after the test. Testing may be terminated 
if participants exhibit significant physical symptoms of shortness of breath, angina, feeling faint or leg pain 
during or after the test. This test has been used successfully in the context we propose in many population-
based studies of older adults as well as the aforementioned LIFE study.11 
 
Risks and discomforts related to the exercise intervention include muscle soreness associated with 
resistance training.  This is a natural, expected phenomenon that occurs with rehabilitative exercise, 
particularly when a person has been inactive for a period of time.  This type of soreness is expected to be 
transient.  Other risks and discomforts include the possibility of muscle strain associated with improper 
technique or attempting to work with a resistance that is not appropriate.  As with any physical activity, 
there is a risk of a cardiovascular event, such as abnormal blood pressure, fainting, irregular heartbeat, or 
cardiac ischemia and heart attack. 
 
Uncommon risks and discomforts 
The criteria for discontinuing a subject's participation include the subject's request, as well as any life-
threatening or potentially disabling event.  Examples of these events include syncope, an injurious non-
accidental fall, hemodynamic collapse, stroke, transient ischemic attack, dysrhythmia, angina, myocardial 
infarction or hospitalization for acute illness. The risk for these adverse events is very low and no different 
than what would be encountered in standard outpatient geriatric rehabilitative care. The BU and SCOC sites 
care for older adults on a daily basis and the therapists employing care as part of the study are very 
experienced clinicians. Consistent with standard operating procedures for safety, if the participant 
experiences an acute life-threatening event, they will be initially assessed by the study PT and if immediate 
urgent care is required 911 will be contacted.  Any chronic, or non-life threatening event will be discussed 
with the Principal Investigator, a Physiatrist with expertise in Geriatric Rehabilitative Care who is either on 
site or reachable by phone. Additionally, we will have a study safety officer. This will be a clinician with 
Geriatric expertise that will adjudicate the safety for continued participation of any individual experiencing 
an adverse event. All events will be recorded and included in the database and reported to the IRB. Any 
participant who develops adverse events during the conduct of study protocols will be given immediate 
medical care under the direction of the PI. They will be referred to their primary care physician for ongoing 
care. It is also possible that the Safety Officer and PCP will decide a participant should temporarily stop 
participation rather than withdraw. In such cases, the PCP will need to grant clearance following recovery 
from illness/injury and prior to prior to participants resuming their participation in the study. 
 
 
VIII. 
POTENTIAL BENEFITS 
 
Participants may experience the benefits of rehabilitative care and regular exercise.  These benefits may 
include: improvements in muscular strength/power, postural stability, flexibility and endurance and 
therefore activities of daily living that utilize these attributes.  In addition, participants may experience 
positive psychological benefits of exercise and increased physical activity such as mood enhancement, stress 

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reduction, and increased self-confidence. Lastly, participants might develop a habit of regular exercise that 
would produce health benefits long after study completion.  
 
The results of this project will have great relevance for the care of older adults. The project has the potential 
to inform several fields within healthcare, including: primary care, rehabilitative care and health services 
research.  The research may improve the prevention and treatment of mobility decline in older adults, which 
in turn, may decrease healthcare costs at large. 
 
IX. 
MONITORING AND QUALITY ASSURANCE 
 
Research staff and physical therapists will be required to demonstrate competence in performing data 
collection.  Training will be based on standardized materials developed for the study.  Training will be 
provided by the PI and his lab manager who have experience in conducting all proposed study measures. 
Under the supervision of the Principal Investigator and the Research Coordinator, study staff will assess all 
data collection forms for completeness and accuracy as well as protocol compliance on a weekly basis. 
Data will be entered directly into and stored within a password protected, HIPAA compliant web-based 
application hosted by Partners HealthCare Research Computing, Enterprise: REDCap. Each participant will be 
assigned a study ID number. All data will be coded by study ID only.  No personal identifiers will be retained 
in the outcomes database. 
 
The master list linking ID numbers to subject identifiers will reside in a separate REDCap database. This 
tracking database will contain patient contact information and will be used to (a) document all contacts with 
participants from initial scheduling calls, to study visits, through the final follow-up including telephone 
follow-up; (b) prompt staff to contact participants to schedule follow-up visits (c) generate periodic reports 
on response rates and success of follow-up contact efforts. Additional study logs tracking communications 
with participants, study progress and adverse events will also be stored on Syncplicity. Syncplicity is 
Partners-approved data storage and file sharing system. Only study staff will have access to these files on 
Syncplicity. We will use Syncplicity to share data with our collaborators at the Center for Neurorehabilitation 
at Boston University College of Health and Rehabilitation Sciences: Sargent College and the Heller School at 
Brandeis University.  
 
Exercise videos and communications with research staff via the Wellpepper application will be identified 
with the same subject ID. Wellpepper runs in a virtual private cloud on Amazon Web Services using MySQL 
and MongoDB databases. PHI is encrypted on the disk using AES256 encryption. Data is also encrypted over 
the wire using HTTPS (port 443). Wellpepper, Inc has filed the Vendor Information Security Plan (VISP) with 
Partners HealthCare.  Approval is pending for use of the Wellpepper app for compliance with safety in 
handling of personal information and compliance with HIPPA regulations. Similarly, Partners Information 
Systems will prepare all of the iPad minis so that they meet Partner’s IS security standards and can be 
disabled if a device is lost or stolen. Participants will be instructed to utilize cellular data over the course of 
their study participation and use of Wellpepper. They will be cautioned against less secure networks such as 
wireless networks that are not password-protected. 
 

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This consent form will be stored in a locked filing cabinet to which only study staff have the key. Identifying 
information about a subject will not be used during the discussion, presentation, or publication of any 
research data. 
 
The Heller School at Brandeis University has developed a comprehensive information security policy and 
built a secure data network to house sensitive data, including Medicare claims. All data is logged and tracked 
from the point of arrival to the point of data destruction. We house all original media (which in this case will 
come from CMS on an encrypted hard drive) with the original files in a locked cabinet. New hard drives are 
logged in physical media tracking book. A copy of the data files will be placed inside the Heller School secure 
domain in a folder with limited access (only people who sign the DUA can be given permission to the folder). 
All analytic files and SAS programs will be stored within the Heller School secure domain. Aggregated results 
will be exported using a sFTP. All statistical programming and project staff sign a code of personal conduct 
and agree to follow the rules of the Heller School and the governing DUA (regardless of institution). In the 
case of CMS paid claims, we cannot take any results out of the secure domain with cell sizes below 12. Both 
the programmers and site PI, Jennifer Perloff, make sure no results that violate this rule are taken outside of 
the secure domain. When the project is over the original files and aggregate data sets are destroyed using a 
triple swipe method that has been approved by CMS. The certification of destruction (COD) is sent to CMS 
and logged in the Heller School DUA tracking system. 
 
The only identifier in the Medicare claims data will be a person level ‘link key’. This is a fake ID created for 
the CMS Chronic Condition Data Warehouse and is different from the beneficiary’s Medicare number or 
Social Security Number. This number is on all claims for the individual. When we destroy the claims data, we 
destroy the person identifier. There are no other cross-walk files. The only other sensitive information is 
dates of services.  
 
For CMS projects, data use is governed by the CMS Data Use Agreement (DUA). CMS has a standard DUA 
that limits the team to the specific project described in the Privacy Board packet. The data cannot be used 
for any other purpose. The PI of the project is responsible for enforcing this and all other data security 
requirements. 
 
 
The Principal Investigator, Dr. Bean, will be responsible for monitoring the data to ensure participant safety. 
Participants will be asked to contact study staff with any adverse symptoms. The PI will speak with subjects 
to make a determination as to the seriousness and nature of the event and what appropriate treatment 
should include. Study staff will discuss participant safety and any issues that arise at weekly meetings with 
the PI and our collaborators at BU, or more frequently as needed. Dr. Bean will review the safety and 
progress of the study with collaborators on a monthly basis.  
 
Safety monitoring procedures will also be reviewed by a Safety Officer (SO). The SO will review the study 
protocol and safety-monitoring plan with all study staff prior to the start of the study. The SO will 
subsequently meet with study staff as needed to review standardized reports addressing subject symptoms 
and deviations from the study protocol. Biannual meetings will be organized with the SO to review the 

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progress of recruitment and retention of subjects, compliance with the protocol, and operating procedures 
with study staff.  
 
The Safety officer will be Sanja Percac-Lima, MD, PhD, a clinician researcher with expertise in geriatrics and 
primary care and credentialed within the Partners Healthcare System.  She will be readily accessible for 
urgent consultation, since she is from the local area. 
 
The study staff, upon discovery, will review adverse events in keeping with Partners Human Research 
Policies. All adverse events/serious adverse events will be reported to the IRB by telephone and in writing 
according to PHS guidelines. Standardized adverse event monitoring forms will be completed. Non-serious 
adverse events will be continually tracked and included in the annual report to the IRB. 
 
 
 
 
 

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