Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach: A Pilot Study of Feasibly and Acceptability
Phase: NA
Conditions: Multimorbidity, Physical Deconditioning
Sponsor: VA Office of Research and Development

Engaging Medically Complex Veterans in Tele-Rehabilitation Using a 
Biobehavioral Approach: A Pilot Study of Feasibility and Acceptability
NCT04942613
July 14, 2022

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COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  303-724-0990 
Protocol #:  21-2773   
Project Title:  Engaging Medically Complex Veterans in Tele-Rehabilitation Using 
a Biobehavioral Approach: A Pilot Study of Feasibility and Acceptability  
Principal Investigator:  Jennifer Stevens-Lapsley MPT, PhD 
Version Date:  07.14.2022  
I.
Hypotheses and Specific Aims:
This is a single-site, randomized pilot study using a two-group (GROUP1 and GROUP2) 
crossover design. Fifty Veterans with medical complexity and deficits in physical function 
will participate. Outcomes will be assessed at baseline (pre-intervention), 6 weeks 
(intervention mid-point), 12 weeks (end of intervention), and 24 weeks. 
AIM 1: To determine the feasibility and acceptability of a multicomponent telerehabilitation 
program. 
Hypothesis 1a: 75% of Veterans will achieve ≥ 80% adherence as measured by 
attendance. 
Hypothesis 1b: At least 75% of Veterans will perceive the program as acceptable 
(≥ 4/5 on Acceptability of Intervention Measure13) and feasible (≥ 4/5 on Feasibility 
of Intervention Measure). In addition, we will monitor adverse events and 
categorize severity (mild, moderate, severe) and relatedness (definitely, probably, 
possibly). 
AIM 2: To assess the preliminary response of a multicomponent telerehabilitation using a 
two-group randomized crossover design and determine variability estimates. Outcomes 
for this aim are accelerometer-based physical activity, physical function, quality of life, and 
loneliness. 
Hypothesis 2: At program end (GROUP1 12 weeks, GROUP2 24 weeks), 
participants will have a trend of improved outcomes (accelerometer 7-day average 
step count with ActiGraph physical activity monitors (ActiGraph Inc. Pensacola FL, 
primary) compared to program start (GROUP1 baseline, GROUP2 12 weeks). In 
addition, using the pooled intervention sample, variability estimates (standard 
deviation), will be determined for change in physical activity, physical function (,30 
second sit to stand14) and self-report measures of physical function (Activity 
Measure for Post-Acute Care15), quality of life (PROMIS 29 Profile v2.016), and 
loneliness (3-item loneliness scale17 Berkman Social Disengagement Scale1). This 
will allow for sample size estimates for the subsequent larger effectiveness trial. 
AIM 3 (exploratory): Explore patient perspectives of the multicomponent telerehabilitation 
program (physical therapy, biobehavioral interventions, technology, and social support 
interventions) and how they contribute to program engagement and participation as well 
as changes in physical activity.  

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Objective 3a: Qualitatively identify factors Veterans associate with program 
engagement and participation as well as short-term changes in physical activity 
(immediately post 24-week outcome assessment); these data will deepen our 
understanding of how and why Veterans engage with the program and its 
components and identify targets for future interventions.  
Objective 3b: Qualitatively identify factors Veterans associate with maintenance of 
physical activity up to 6 months after program completion, with an emphasis on 
social support, strategies learned from biobehavioral interventions, and 
technology. These data will help identify key factors related to maintenance of 
physical activity, inform future iterations of this multicomponent program, and 
identify targets for future interventions. 
II. 
Background and Significance:  
A.1. 
Older Veterans with complex health conditions are often excluded from 
rehabilitation research 
Veterans with multiple comorbidities are one of the most vulnerable patient  populations 
as well as a large and growing proportion of Veterans Health Administration (VHA) 
beneficiaries.18 Older Veterans with complex health conditions are at high risk for 
isolation,19 disability,20 adverse health events (e.g., hospitalization and death), mental 
illness,21 and heavy healthcare utilization.20 Historically, musculoskeletal research has 
often excluded medically complex older adults, which has hindered development and 
evaluation of practical and effective rehabilitation strategies for this population. The 
reason for this selection bias is multifaceted. The population is heterogeneous in age, 
cognitive status, medical status, psychological comorbidity, living environment, and social 
support.22 In addition, this at-risk population often experiences simultaneous acute and 
chronic conditions that contribute to variability in rehabilitation outcomes and high rates of 
loss to clinical follow-up. Ethical considerations also create additional barriers to research 
participation, as many older Veterans have cognitive impairments that impact the informed 
consent process.23 However, such selection bias limits the generalizability of study 
findings and the likelihood that existing or new interventions will adequately address the 
needs of this growing population.22 Therefore, rehabilitation research targeting medically 
complex older Veterans is needed to optimize their physical function and enhance their 
life participation. 
A.2. 
Physical function is a powerful biomarker of health and clinical outcomes for older 
adults 
Although disability risk factors are complex and multifactorial, there is evidence that 
physical function alone is a powerful biomarker of overall health following hospitalization, 
and a strong independent predictor of hospital re-admission.24-27 Poor physical function is 
also associated with reduced walking ability, lower extremity weakness, and increased 
risk of falls.24,28-31 Older adults with lower levels of physical activity at home are 
approximately 6 times more likely to be readmitted within 30 days of acute hospitalization 
than those with higher levels of physical activity.24 Furthermore, objective lower extremity 
weakness is associated with increased likelihood of requiring assistance at home.32 This 

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evidence highlights the need for intensive and multimodal interventions directly 
addressing factors that contribute to low physical function and physical activity in this 
population. Most importantly, physical function is a modifiable risk factor, even in 
medically complex older adults, which previous studies suggest can be effectively 
addressed with more intensive rehabilitation strategies. 
A.3. 
Social isolation of older Veterans is associated with poor physical function 
Social isolation is also associated with poor physical function,33 and is predictive of 
rehospitalization, premature death, and poor health outcomes34 in older Veterans. Active 
older adults perceive social support and connectivity as important motivators for 
exercise.11,12 In studies of healthier populations the social connection provided by group 
exercise also boosts adherence,35 increasing long-term sustainability of exercise benefits. 
However, older Veterans with poor health status have geographic (e.g., rural) and 
physical barriers to rehabilitation participation and often experience greater social 
isolation. The use of technology, such as telehealth platforms, provides an avenue to 
address the problem of Veteran social isolation. While online social activity is a detriment 
to perceived health for young adults, older adults report feeling more social support and 
less isolation when connected online.36 Increasing Veteran social connectivity may 
augment conventional rehabilitation to improve older Veterans’ physical activity, life 
participation, and sustained outcomes. 
A.4. 
Conventional Rehabilitation Strategies are Insufficient to Produce Meaningful 
Gains 
We have found rehabilitation exercise dosage in a variety of settings often does not 
provide a meaningful physical challenge for older adults.6 Across the U.S., the content 
and intensity of conventional rehabilitation for medically complex older adults is 
substantially under-dosed.37-39 In the rare cases where resistance training is used, the 
loads are often equivalent to 2 pounds or less. This is not sufficient to induce physiologic 
adaptations.40 In contrast, high-intensity resistance training tailored to individual patient 
tolerance integrates principles of physiologic tissue overload and resistance training into 
functional rehabilitation interventions to achieve better outcomes. Despite this, clinicians 
apply conservative interventions to medically complex populations because they fear 
patient injury or expect patients to resist working at higher intensities.41,42 Yet, when 
employed correctly, there is no greater risk of injury or patient refusals.43,44 In older adults, 
high-resistance, low repetition strengthening fosters better functional outcomes than 
traditional strength training, including greater gains in strength45,46 and physical function.47 
Furthermore, data from our group suggests practice change from low-intensity to high-
intensity functional resistance interventions is influenced by patient and clinician self-
efficacy,48 which are modifiable through enhanced patient engagement and enriched 
training for rehabilitation clinicians. Furthermore, improvements in physical function are 
sustained well beyond a discrete episode of care,43 helping to protect against the decline 
that might occur with the next expected insult. 
III. 
Preliminary Studies/Progress Report:   

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B.1.1. Clinical Research Experience 
Dr. Stevens-Lapsley, PT, PhD (PI) has more than 20 years of clinical research experience 
in working with medically complex patients and interdisciplinary teams in implementing 
rehabilitation programs. Dr. Stevens- Lapsley also has prior experience with implementing 
a telerehabilitation platform for patients after total knee arthroplasty (NIA R44 AG055341). 
Dr. Lauren Abbate, MD, PhD (Co-Investigator) is the Associate Director- Clinical at the 
Eastern Colorado Health Care System (ECHCS) Geriatric Research, Education and 
Clinical Center (GRECC) and the Medical Director for the ECHCS Gerofit Program. She 
has recent experience through Gerofit with telehealth delivery of exercise interventions. 
Dr. Cory Christiansen, PT, PhD (Co-Investigator) has worked closely with Dr. Stevens-
Lapsley over the past decade and has participated in the design, implementation, and 
publication of multiple rehabilitation research studies involving a variety of older adult 
populations. Most relevant to the current proposal, the Co-I has extensive experience 
implementing biobehavioral strategies to improve physical activity in patients following 
Total Knee Arthroplasty9 and dysvascular lower limb amputation.8 Dr. Katherine Nearing, 
PhD (Co-Investigator) is the Associate Director of Education and Evaluation for the VA 
ECHCS GRECC. She will serve as the lead evaluator for this study. Dr. Jeri Forster, PhD 
(Co-Investigator) is a biostatistician who is the Director of the VA Data and Statistical Core 
for the VISN 19 Mental Illness Research, Education and Clinical Center (MIRECC). She 
will provide expertise on issues related to study design, database management, quality 
control, data analysis, and the preparation of manuscripts. Dr. Hillary Lum, MD, PhD (Co-
Investigator) clinical expertise in geriatrics within the VHA system, in addition to her 
experience with telehealth care delivery using VA Video Connect will facilitate smooth 
program implementation. 
B.1.2. Preliminary Studies 
This new line of research builds on the collective experience of the investigative team. 
The PI and Co- Investigators have worked together over the past 7 years to 1) develop 
progressive rehabilitation strategies for medically complex patients (VA RR&D I21 
RX002054, VA RR&D I01 RX001978), 2) develop and test biobehavioral strategies to 
improve physical activity for patients following dysvascular lower limb amputation8 and 
total knee arthroplasty,9 and 3) test and refine telerehabilitation delivery for patients 
following total knee arthroplasty (NIA R44 AG055341). This study will be the first to 
combine these lines of research into a coherent multicomponent program. Further, this is 
the first study to determine the safety and feasibility of telerehabilitation approaches for a 
high-risk, medically complex population. The investigative team’s collective experience 
and ongoing work in these areas positions them uniquely to lead the proposed 
investigation. 
IV. 
Research Methods 
C.1 Outcome Measures:   
Aim 1: Feasibility outcomes provide information to help determine if a larger study should 
be performed. Feasibility includes adherence, acceptability, and safety, and satisfaction. 
Additional factors may influence feasibility, and the following surveys for will be assessed 

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at program end for Veterans and therapists: Feasibility of Intervention Measure,13 
Acceptability of Intervention Measure,13 Intervention Appropriateness Measure.13 
Satisfaction is measured by V-signals which is a survey specific to the VA; it measures 
satisfaction associated with telerehabilitation services. Additionally, we will monitor 
recruitment rate (proportion of Veterans enrolled out of those screened) and retention 
(proportion of Veterans who complete program out of all enrolled) to inform feasibility of a 
larger randomized controlled trial for effectiveness. 
Aim 2: Preliminary responses to the interventions will be determined via performance-
based and self-report measures. Physical activity behavior outcomes (hypothesis 2) will 
include average 7-day step count (accelerometry; primary), self-efficacy (Self-Efficacy for 
Exercise Scale2) and exercise readiness to change (Exercise Stages of Change).70 
Physical function outcomes will include 30 second sit to stand test,3 arm curl test,72 2-
minute step test,72 and self-report Activity Measure for Post-Acute Care (AM-PAC).15 
Social isolation and loneliness outcomes will include 3-Item Loneliness Scale17 and the 
Berkman Social Disengagement Scale.1 The PROMIS-29 v2.016 will measure quality of life 
(summative score), social support (subscale), and mental health (subscale). In addition, 
descriptive measures will be collected at baseline including demographics, medications, 
cognition (T-MoCA69), depression (Patient Health Questionnaire-9 for depression73), 
anxiety (General Anxiety Disorder-774), Mobile Device Proficiency Questionnaire,75 and 
comorbidities (Charlson Comorbidity Index68). 
Aim 3: Qualitative data will be collected primarily through semi-structured one-on-one key 
informant interviews, which will be recorded with the participant’s permission. All 
interviews will be conducted through the same virtual platform participants will have been 
using throughout program participation. To validate data and findings, additional 
qualitative data will be collected from documentation in CPRS (restricted to study-related 
documentation) and voluntary feedback provided though the veteran satisfaction survey 
(V signals—a validated survey instrument used routinely within the VA). Objective 3a: 
These interviews will be conducted within 3 weeks of program completion (12-weeks for 
participants in Group1 and 24 weeks for participants in Group2). The interviews will last 
approximately 45-60 minutes. We will purposively sample Veterans based on level of 
technology engagement [high engagers (respond to Annie ≥ 80%) versus low engagers 
(respond to Annie < 50%)] and group sessions attendance [high attendance (≥ 80%) 
versus low attendance (< 50%)]. We will continue to sample Veterans until thematic 
saturation is reached for each group. Objective 3b: We will conduct follow-up interviews 
with the Veterans who completed initial interviews (from objective 3a); these interviews 
will last approximately 30-45 minutes and will occur between 3 to 6 months following their 
initial interview.  
Description of Population to be Enrolled:   
In this study, the target population is older Veterans, including those identified as “high-
need, high-risk" by the Geriatrics & Extended Care Data & Analysis Center (GECDAC); 
this designation includes Veterans who have experienced a  significant health event in the 
last 12 months (e.g., hospitalization) and have a Frailty Index score ≥6. Veterans will be 
recruited through the VA Eastern Colorado Health Care System. Potential Veterans will be 
identified by the GECDAC and/or by providers in the Geriatric Specialty Clinic, Home 

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Based Primary Care, and  inpatient and outpatient rehabilitation settings. Potential 
Veterans with whom we have a treatment relationship will be pre-screened through 
standardized chart review followed by standardized phone screen. If eligible and 
interested in participating, Veterans will provide informed consent and be enrolled in the 
study; once enrolled, they will be randomized to either a waitlist control (GROUP2) or 
experimental (GROUP1) group. Participants will complete surveys and direct observation 
(Aims 1 & 2). Veterans will also undergo performance-based assessments of physical 
activity and physical function and complete self-reported measures for physical function, 
quality of life, loneliness, social support, and mental health. 
Formal Inclusion/Exclusion Criteria 
Inclusion 
• 
≥ 60 years of age 
• 
Multiple chronic conditions (Functional Comorbidity Index68 ≥ 3) 
• 
Impaired physical function ( ≤ 10 on 30 second sit to stand) 
Exclusion 
• 
Life expectancy < 12 months 
• 
Acute or progressive neurological disorder (e.g., Amyotrophic Lateral Sclerosis, 
recent stroke) 
• 
Moderate to severe dementia without caregiver assistance (< 18 on telephone 
Montreal Cognitive Assessment (T-MoCA)69) 
• 
Unstable medical condition precluding safe participation in progressive 
rehabilitation (e.g., unstable angina) as defined by ACSM guidelines 
We plan to randomize 50 Veterans (25 randomized to each group), with the goal of having 
40 Veterans complete the study (20% attrition rate). Due to our enrollment process, we 
plan to have 70 Veterans sign the informed consent; this will allow for up to 20 Veterans to 
complete evaluation but be found ineligible based on identified exclusion criteria. The goal 
of the study is to obtain a representative sample of older Veterans at risk for, or presenting 
with, impaired physical function contributing to fall risk, physical dependence, and risk for 
hospitalization. Both sexes and all races are included in the study, however the Veteran 
population is predominantly male and Caucasian, which will be reflected in the enrollment. 
D. 
Study Design and Research Methods   
We propose a pilot, two-arm randomized trial using a waitlist control to determine the 
feasibility, acceptability, and safety (AIM 1) of a 12-week multicomponent telerehabilitation 
program. We will also assess the preliminary response (AIM 2) to this 12-week 
intervention. Participants (n=50) will be randomized to GROUP1 or GROUP2 using 
computer-generated random blocks of 2 and 4, stratified by sex. A waitlist control 
(GROUP2) will be used to simultaneously achieve the aims and ensure that all 
participants receive the intervention. Data will be collected at baseline (pre-intervention), 

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6-weeks (intervention midpoint for GROUP1), 12 weeks (intervention end for GROUP1, 
primary endpoint), and 24 weeks.  
Setting & Recruitment:  
Following consent and prior to baseline assessment and randomization, each participant 
will complete a physical therapy evaluation performed by a licensed physical therapist. 
The purpose of this evaluation is to ensure the Veteran is appropriate for the planned 
intervention and is eligible for the study. The evaluation may include standard evaluation 
tasks including but not limited to chart review, subjective history, and functional 
assessment. 
Initial evaluation, intervention, and testing will occur through telehealth via VA Video 
Connect using a site-to-home format. Dedicated telehealth rooms are available for the 
study team in the ECHCS GRECC. Veterans will have the option of using their personal 
device (e.g., tablet, computer) or a VHA-issued tablet. 
Veterans will be recruited from the Geriatric Specialty Clinic, Emergency Department, 
Home Based Primary Care, and Inpatient and Outpatient rehabilitation services through 
the VA ECHCS. Veterans also will be recruited via flyers provided to/posted on:  VA social 
media, VA GRECC (Geriatric Research Education and Clinical Center) Website; UCD 
Website, to facilities and clinicians in the VISN-19, VA CLC colleagues, in VAMC patient 
rehab discharge folders, to Colorado Visiting Nurses Association, and to non-VA clinicians 
throughout the VISN19 region.  Additionally, we are approved via DART to review VISN19 
medical records for study eligibility.  We do not anticipate any difficulties with recruitment 
because of the large volume of candidates who are currently waiting for availability of 
rehabilitation services. However, if recruitment goals are not met after six months, 
additional recruitment of Veterans will occur through established relationships with 
regional Colorado hospitals. Potential participants will be pre-screened through 
standardized chart review followed by standardized phone screen. 
Intervention 
Waitlist Control: 25 Veterans will be randomly assigned to GROUP2 for the first 12 
weeks prior to initiating the telerehabilitation program intervention. To encourage 
retention, Veterans will participate in an hour-long educational session every 2 weeks for 
a total of 6 sessions. These online educational sessions will also include a facilitated 
question/answer session. Topics will include general health management such as 
nutrition, stress reduction, and sleep hygiene. At the completion of 12 weeks, Veterans in 
GROUP 2 will crossover into the multicomponent telerehabilitation intervention. 
Multicomponent Telerehabilitation Program: 25 Veterans will be randomly assigned to 
immediately receive the multicomponent telerehabilitation program intervention 
(GROUP1). The three components include 1) individual and group progressive, high 
intensity resistance training rehabilitation, 2) biobehavioral interventions, and 3) social 
support. A physical therapist (PT) will deliver telerehabilitation, and Veterans will 
participate in 12 individual sessions and 24 group sessions over the course of 12 weeks. 

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Biobehavioral interventions will occur 1time per week for a total of 6 sessions during the 
early part of the program and 2 booster sessions during the latter part of the program. 
Social support group discussions will occur following specified group telerehabilitation 
session for a total of 12 sessions. 
Multicomponent Telerehabilitation Program Intervention and Rationale 
Progressive Rehabilitation: Progressive rehabilitation involves physiologically-tailored 
high-intensity resistance training during functional movements (e.g., sit to stand transfer, 
stair navigation), balance training, and gait retraining to appropriately challenge individuals 
to facilitate desired change.  
Physical therapists will deliver progressive telerehabilitation during both individual and 
group sessions. Individual sessions will allow for orientation, individualization, and 
familiarization of various progressive rehabilitative interventions. Virtual group sessions 
will occur with the group in a virtual environment; each Veteran will attend the group VA 
Video Connect visit from their preferred location (e.g., home). Group sessions will help 
facilitate social support. 
Biobehavioral Interventions: Our research team has extensive experience implementing 
biobehavioral interventions8,9 which are theory- and evidence-based.7,10 There will be 8 
individual sessions over the course of the 12-week program. During the early part of the 
program, the PT will deliver 6 sessions focused on behavior change techniques (Table 1). 
The PT will deliver these interventions at the end of individual progressive rehabilitation 
sessions. The first session will provide an overview of the biobehavioral program and the 
different techniques that will be discussed (e.g., self-monitoring, problem solving, action 
planning, education, barrier/facilitator identification, tailored feedback, and 
encouragement). Each session will include education on the primary topic for the day, and 
then focus on developing skills and independence applying that technique. 
Veterans will receive two individual booster sessions during the latter portion of the 
intervention. A VA-approved App (Annie App) will be used to augment the biobehavioral 
treatments. For example, daily step count can be tracked by responding to SMS text 
message prompts delivered by Annie. The Veteran is then able to view their progress 
(through mobile App or web portal) providing feedback on their performance. 
Table 1. Components of the Biobehavioral Intervention 
Intervention 
Technique 
Progression from Therapist Coaching (left) to Participant Self-Management (right) 
Education 
Therapist delivers education topic* (e.g., Self-Monitoring, 
Problems Solving, Identifying Barrier/Facilitators, Action Plans). 
Participant reports most important information 
learned. 
Self-Monitoring 
Therapist guides participant in tracking daily activity minutes & 
session participation since last visit. 
Participant tracks weekly activity minutes and 
session participation. 
Tailored Feedback 
Therapist leads collaborative review of activity and participation 
data for action plan goal setting. 
Participant leads review of activity and 
participation data and other physical activity 
goals. 

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Barrier/Facilitator 
Identification 
Therapist guides participant to identify barriers/facilitators of goal 
attainment. 
Participant self-identifies barriers and facilitators
for goal attainment. 
Promotion of 
Problem Solving 
Collaborative generation of solutions to overcome barriers to goal 
attainment. 
Participant generates solutions to identified 
barriers to goal attainment. 
Action Planning 
Collaborative activity goal generation. Therapist guides, using 5-
10% increase from daily activity minutes from previous week 
target. 
Participant-led weekly goal generation. 
Therapist ensures independence in action 
planning. 
Encouragement 
Therapist reviews plan for the next week, while encouraging 
participant on successes attained toward improved physical health. 
Participant leads the review of the plan for 
upcoming week. 
* Each week will have a specific “take-home” message linking physical activity and 
movement behavior to health. Messages will be brief and based on research evidence. 
Social Support: Social support is a key component of our program to address social 
isolation and perceptions of loneliness. We will foster a sense of community and family 
among Veterans enrolled in the program through virtual group telerehabilitation sessions 
and group discussions. During group telerehabilitation, therapists will purposefully engage 
Veterans, providing encouragement on performance while also facilitating peer support 
and encouragement. The group discussions, which occur at the end of group 
telerehabilitation sessions, will have core components to reinforce biobehavioral strategies 
and allow Veterans to share their experiences, successes, and struggles implementing 
our program. Group discussions will be iterative by encouraging Veterans to suggest 
topics for discussion and ideas for improvement. 
Outcomes: All outcomes will be evaluated by a blinded assessor. Aim 1: Feasibility 
outcomes provide information to help determine if a larger study should be performed. 
Feasibility includes adherence, acceptability, and safety, and satisfaction. Additional 
factors may influence feasibility, and the following surveys will be assessed at program 
end: Feasibility of Intervention Measure,13 Acceptability of Intervention Measure,13 
Intervention Appropriateness Measure.13 Satisfaction is measured by V-signals which is a 
survey specific to the VA; it measures satisfaction associated with telerehabilitation 
services. Additionally, we will monitor recruitment rate (proportion of Veterans enrolled out 
of those screened) and retention (proportion of Veterans who complete program out of all 
enrolled) to inform feasibility of a larger randomized controlled trial for effectiveness. 
Aim 2: Preliminary responses to the interventions will be determined via performance-
based and self-report measures. Physical activity behavior outcomes (hypothesis 2) will 
include average 7-day step count (accelerometry; primary), self-efficacy (Self-Efficacy for 
Exercise Scale2) and exercise readiness to change (Exercise Stages of Change).70 
Physical function outcomes will include 30 second sit to stand test,3 arm curl test,72 2-
minute step test,72 and self-report Activity Measure for Post-Acute Care (AM-PAC).15 
Social isolation and loneliness outcomes will include 3-Item Loneliness Scale17 and the 
Berkman Social Disengagement Scale.1 The PROMIS-29 v2.016 will measure quality of life 
(summative score), social support (subscale), and mental health (subscale). In addition, 
descriptive measures will be collected at baseline including demographics, medications, 
cognition (T-MoCA69), depression (Patient Health Questionnaire-9 for depression73), 
anxiety (General Anxiety Disorder-774), Mobile Device Proficiency Questionnaire-16,75 and 
comorbidities (Functional Comorbidity Index68). 

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ActiGraph physical activity monitors (ActiGraph Inc. Pensacola FL) will be used to obtain 
an objective measure of physical activity (PA). ActiGraph activity monitors assess PA 
using accelerometry, which allows objective evaluation of the relative volume (steps/day) 
and intensity (activity counts) of physical activity with high validity and reliability.76-78 Each 
participant will wear the ActiGraph for 10 days at the beginning and end of their 
intervention window (baseline and week 12 for GROUP1, week 12 and week 24 for 
GROUP2). The ActiGraph monitor will be used only for outcome data (not intervention) 
and provides no feedback to participants. 
E.   Description, Risks and Justification of Procedures and Data Collection Tools: 
Potential Risks (Aim 1 and Aim 2) 
Study Intervention and Assessments 
We anticipate no greater risk than the minimal risk associated with standard 
telerehabilitation for Veterans participating in this study. All interventions and assessments 
are considered a part of physical therapy clinical practice. Because a physical therapist is 
not physically present with the participant during sessions, there is an increased risk for 
falls compared to in-person rehabilitation. Exercise is associated with inherent risks 
including muscle soreness, muscle strain, shortness of breath, and cardiac events. 
Precautions will be taken to minimize risks as follows: 
1. Veterans will receive education on expected side effects of exercise (muscle 
soreness, shortness of breath) and methods to reduce fall risk prior to initiation of 
interventions. Education will also include signs of distress that should be 
communicated to the study team (dizziness, light headedness, symptoms of 
myocardial infarction) 
2. Veterans will verify their physical location (address) in the event that Emergency 
Medical Services need to be alerted during the session 
3. Vital signs (blood pressure, heart rate) will be assessed pre- and post- intervention 
to monitor physiologic response to exercise (more details below); additional and 
repeated measures may be taken as indicated. Veterans will be provided with 
equipment (automated blood pressure cuff, pulse oximeter) to monitor their vital 
signs and will be instructed on proper use 
4. A licensed physical therapist will provide supervision for all study-related 
intervention and assessment activities remotely through telephone and/or VA 
Video Connect, which will afford the ability to monitor for signs of distress 
(dizziness, shortness of breath greater than expected) 
5. Interventions will be modified based on each Veteran’s physical function, fall risk 
assessment, and safety concerns (exercises performed sitting versus standing; 
standing exercises performed in close proximity to sturdy surface for hand support) 
6. In addition to the physical therapist, support personnel will be present during group 
telerehabilitation to monitor for signs of distress and assist in the event of an 
emergency 
7. Telerehabilitation sessions will be conducted when another adult is present as an 
additional safety measure  
8. Veterans will be encouraged to take rest breaks as needed to manage exercise 

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associated fatigue, shortness of breath, and thirst. 
Additional safety measures may be used based on each Veteran’s individual need (self-
reported perceived exertion, glucose monitoring). 
Vital signs are an objective indicator of physiologic response to exercise. Physical 
therapists will be trained in appropriate vital sign ranges for rest and exercise to assess 
appropriateness and safety for exercise. Prior to any exercise, the Veteran will self-assess 
blood pressure and heart rate. If blood pressure is outside of normal ranges (systolic < 
90mmHg or > 180mmHg; diastolic < 50mmHg or > 100mmHg), the Veteran will be 
instructed to rest for 10 minutes and reassess. The Veteran may assess up to 3 times 
total. If blood pressure continues to be out of normal ranges and/or the Veteran is 
experiencing symptoms (dizziness, shortness of breath, etc.), the PT will defer study 
related activities and consult with study physician. If signs or symptoms of distress occur 
during the telerehabilitation session, the Veteran will be instructed to sit and rest and self-
assess vital signs. The same procedure as above will be followed. In the event of an 
emergency, the PT will alert Emergency Medical Services through VA Video Connect. 
For the purposes of safety monitoring, all adverse events occurring during and between 
study related activities will be recorded. The physical therapist will assess for adverse 
events at the beginning of each telerehabilitation session. Falls will be defined as 
“inadvertently coming to rest on the ground, floor, or other lower level, excluding 
intentional change in position,” (World Health Organization) and characterized as 
unrelated, possibly, probably, or definitely related to study procedures. Additional fall 
information including circumstances and associated injuries will be collected. Any reported 
falls occurring outside of individual/group sessions will be discussed at the subsequent 
individual session or within 24 hours if medical care is required. Fall occurrences (injurious 
and non-injurious) and other adverse events will be reviewed on a monthly basis. Other 
exercise side-effects, such as muscle pain, fatigue, shortness of breath, and minor strains 
during therapy will be documented and monitored by Dr. Stevens-Lapsley. Based on the 
existing literature80 and our own clinical experience with rehabilitation (VA RR&D 
I01RX002417), we anticipate the frequency of these side-effects to be extremely low. 
Surveys 
We will administer surveys to enrolled patients via telephone, VA Video Connect, or CCTSI 
REDCap, dependent on Veteran preference. All collected data will be stored in CCTSI 
REDCap. Surveys will be used to assess participants’ cognition, perceptions of study-
related activities, and perceptions of physical and mental health. Participants may 
experience discomfort when answering questions about their health; patients will be 
reminded that they can choose not to answer any question and that all study data will be 
coded with a participant ID to maintain confidentiality. Research team members will 
compile data into a secure database for analysis and all data will be de-identified. The 
main risks to this portion of the trial are risks of breaching confidentiality of data. 
Interviews 
The questions outlined in the interview guides (provided with this application) explore 

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perceptions of the program and how the different components of the program impacted 
participation and/or physical activity behavior change. Generally, participants will be asked 
to reflect on their experiences during the program. Questions do not delve into personal 
issues, but rather require individuals to be circumspect and to talk in terms of generalities. 
For this reason, we do not anticipate that the nature of the questions/ topics explored will 
cause participants any emotional or psychological distress. To the contrary, we will 
emphasize that aspects of their experience in relation to the telerehabilitation program that 
they choose to share can help the study team improve the program to optimize the benefit 
for Veterans. The opportunity to have their input potentially improve services and care for 
other Veteran tends to be viewed positively by Veteran peers. As is customary, members 
of the research team will communicate that participation in these interviews is voluntary, 
they can ask questions at any time, they can decline to respond to any question, they can 
stop or withdraw their participation at any time, and decisions to decline to participate or 
answer any question will not affect their healthcare. 
The time required to participate in the interview and any associated inconvenience this 
may cause is also a potential risk. We will explain that interviews are estimated to require 
an hour of the individual’s time, and we will schedule interviews on a day and at a time 
convenient for them. Participants who are being invited to take part in an interview will 
have completed a 12-week telehealth program, during which they consistently (2-3x/week) 
demonstrated the ability and willingness to take part in virtual activities for an hour in 
duration. This commitment is similar to the requirement of participating in the interview. 
We will use the same virtual, secure platform (VA Video Connect) to conduct the 
interviews so the technology will be familiar to each person. Therefore, we do not 
anticipate this aspect of participating in the interview to cause any undue stress.   
General Risks 
As with all clinical research studies, there is the general risk of breach of confidentiality or 
data security. To minimize this risk, only the minimal necessary data will be collected, and 
we strive to maintain confidentiality. Only the researchers team members involved in the 
study will have access to the data that is collected. Paper data will be kept in locked filing 
cabinets in locked offices of the VA researchers. Electronic data will be stored and 
managed in a password protected computerized database that is behind a firewall (i.e., 
REDCap). 
All assessments and interventions in this study are considered to be low risk. We believe 
we have minimized risks by applying usual safeguards for instructing participants in 
physical activity and for conducting telerehabilitation. Side effects, such as muscle pain, 
fatigue, minor sprains or strains, or falls during testing will be recorded by the physical 
therapist and monitored by Dr. Stevens-Lapsley. As indicated previously, we anticipate 
the frequency of these side effects to be extremely low based upon existing literature and 
our own clinical experience with the intervention. 
We will maximize the safety of our participants with the following procedures: 
1. Individuals with absolute contraindications to testing and training will be excluded 
based on the inclusion/exclusion criteria. 

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2. Prior to initiating any study-related activities during a telerehabilitation session, 
participants will be asked to identify their physical location (address) if Emergency 
Medical Services need to be alerted for any reason during the session. 
3. All study-related intervention and assessment activities will be supervised by a 
licensed physical therapist. Physical therapists will conduct a falls risk assessment 
at the first telehealth sessions to determine the participants’ level of function and 
potential needs for support and safety during the session (e.g., use of hand-held 
support on a countertop during exercise); this approach will reduce the risk for falls 
and injury. Additionally, interventions and assessments will not be conducted for 
patients who are unable to perform the tasks (by patient report or clinicians’ 
judgment). 
4. Furthermore, when at all possible, sessions will be conducted when another adult 
is present as an additional safety measure. 
5. When completing surveys with potentially sensitive questions, participants will be 
reminded that they can choose not to answer any question and that all data is only 
linked to a participant ID in order to maintain confidentiality and anonymity. 
   F.   Potential Scientific Problems:   
Mobile-Health technology: Durability and continued functionality of technology is a 
concern when using any technology. The mobile-health tablets used in this study have 
been implemented for standard-of-care use for a variety of purposes currently in the VA 
ECHCS. If a tablet becomes dysfunctional, replacement units are available so that an 
immediate back-up unit can replace the dysfunctional unit. The VHA will provide mobile- 
health technical support for the duration of the study. Finally, the intervention is not 
dependent on type of tablet used, so changes in mobile-health tablets in the future will not 
necessitate a change in intervention. 
Lack of long-term follow-up: Creating a change in physical activity behavior for an older 
adult population is a major challenge. We will collect data out to 24 weeks (GROUP1) to 
determine maintenance of intervention effects. We expect that activity changes may be 
reduced at the 24-week time period for GROUP1 compared to the 12-week test point, but 
that the activity will continue to be higher than baseline, based on data from studies of 
patients with other chronic diseases.79 
Heterogeneity of medically complex older adults: Medically complex older adults are 
heterogenous in age, cognitive status, medical status, psychological comorbidity, living 
environment, and social support.22 Additionally, they experience acute exacerbations of 
chronic conditions impacting their response to treatment and contributing to high drop-out 
rates among this population. To accommodate for this from our experiences, we 
anticipated a higher attrition rate (20%) and adjusted enrollment accordingly. 
G.   Data Analysis Plan:   
Analysis Plan. Analyses will be performed in SAS v 9.4 or above and hypothesis tests will 
be two-sided, assuming an alpha level of 0.05. Participant characteristics and outcome 
variables will be summarized using means, standard deviations (SD), medians, ranges, N 
and percent, as appropriate. 

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Aim 1. The percent of Veterans (1) achieving ≥ 80% adherence and (2) scoring ≥4/5 on 
the Acceptability of Intervention Measure will be calculated with associated 95% exact 
binomial confidence intervals. We will additionally calculate the proportion of adverse 
events that are found to be possibly, probably, or definitely related to the intervention. 
Aim 2. Given the small samples, the median change from baseline to 12 weeks for those 
randomized to the intervention will be compared between the groups using a Wilcoxon 
rank-sum test for each outcome of interest (7-day average step count as primary). 
Estimates of variability (SD) in the change from pre to post-intervention for the pooled 
sample completing the intervention (N=40) will be calculated for each outcome and 
reported with 95% CIs. These estimates and the CIs will inform sample size calculations 
for a future effectiveness trial. 
Aim 3: Semi-structured interviews will be recorded with permission and professionally 
transcribed. The accuracy and completeness of transcripts will be validated by a member 
of the study team. Thematic analysis will be conducted by two researchers as described 
by Fereday and Muir-Cochrane52 using a hybrid deductive-inductive analysis approach. A 
codebook will guide systematic analysis. The initial codebook will be developed using key 
constructs from Social Cognitive Theory, Technology Acceptance Model,53 and emerging 
social isolation theory specific to older adults.54 Constructs will also be added to the 
codebook as new concepts emerge inductively throughout analysis. Multiple passes will 
be taken through the data to support iterative and reflexive processing of key insights 
salient to the research questions and hypotheses outlined for the study. Coding from both 
researchers will be compared and any disagreements/discrepancies will be resolved 
through weekly processing discussion meetings. Results will be transferred to a matrix to 
organize the data by salient themes and support further interpretation.    
Data Management: 
Interviews will be recorded with permission from the participant by a member of the study 
team. Sound files will be encrypted using the Olympus DS-9000 Digital Voice Recorder (a 
VA-approved device). The audio file will be transferred securely using box.com. The 
interviews will be transcribed by a contracted employee of Transcription Outsourcing LLC, 
a VA-approved vendor. Once transcripts are complete, these Word documents and the 
associated sound files will be downloaded and saved on a shared network drive 
accessible only by research personnel of the university; once files are downloaded and 
saved to the shared network drive, the associated sound file and transcript will be deleted 
from box.com. These data will be stored electronically on a secure network drive 
(maintained by the university) in subfolders with a complex directory path. Study staff will 
use password-protected computers maintained by and/or located at the university to 
process information collected for this study. Any hard copies of data collected during 
interviews (i.e., transcripts and hand-written notes) will be stored in a locked filing cabinet 
to which only designated members of the research study team will have access. The key 
to this filing cabinet will be kept in a separate, secure location. The participant’s study ID 
will be used to label the electronic and hard copies of the data obtained for this study 
(e.g., sound files, associated transcripts, or interview notes).  
 

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If parts of an interview are featured in a report (e.g., a quote is used to represent a given 
theme and/or a composite story is featured to illustrate a common scenario/experience), 
we will confirm that there is no identifying information included. Names will be masked. 
For example, when sharing findings resulting from this study, specific names would be 
replaced in text with a descriptor such as [physical therapist] or [spouse]. 
H.  Summarize Knowledge to be Gained:   
The VA has established rehabilitation programs for inpatient, home, and outpatient 
settings, but these typically require in-person attendance, address one area of functional 
impairment, and under-dose the intensity of rehabilitation. Further, Veterans often face 
barriers to attending in-person appointments; for example, living in rural locations, lack of 
transportation, or limited social support. As a result, many Veterans continue to have 
residual physical function limitations that prevent them from participating in life roles, 
navigating their home and the community, and participating in continued rehabilitation 
exercises in the community setting. It is unclear how telehealth strategies could be 
effectively and safely utilized to provide rehabilitation services to Veterans who lack 
access to these important services. Indeed, telehealth platforms offer a solution to 
overcome access barriers (rurality, transportation), but no current research applies 
telerehabilitation to medically complex older Veterans. 
The current study will assess the feasibility, acceptability, and safety of the multi-
component rehabilitation program for high risk, high need Veterans with multiple 
comorbidities and functional deficits. Additionally, response to the multicomponent 
telerehabilitation program will also be measured to determine preliminary effectiveness. 
Study findings will guide refinement of telerehabilitation methods, so they are effective, 
easily implemented, and safe. This study will provide critical insight for providers regarding 
telerehabilitation for medically complex older Veterans and its utilization to improve 
physical function and concurrently reduce the impact of social isolation. 
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82.