Building Capacity to Improve Community Participation for People Aging With Long-Term Disability Through Evidence-Based Strategies
Phase: NA
Conditions: Physical Disability
Sponsor: Washington University School of Medicine

 
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1 
 
  
Protocol for Increasing Community Participation for Individuals Aging with a Long-Term Physical 
Disability 
 
 
 
 
 
Principal Investigator 
Susan Stark, PhD*  
Washington University in St. Louis, Program in Occupational Therapy 
 
Co-investigators 
Kerri Morgan, PhD 
Washington University in St. Louis, Program in Occupational Therapy 
 
Michelle Putnam, PhD  
Simmons College, School of Social Work 
 
Aimee Wehmeier, MBA  
Paraquad, Inc 
 
*To whom correspondence should be addressed 
 
Washington University School of Medicine 
5232 Oakland Ave,  
St. Louis, MO 63110 
 
 
 
 
 
 
Version: Original, October 25, 2017 
 
 
Clinical Trial #  
 
Funding for the trial is through the National Institute on Disability, Independent Living, and Rehabilitation 
Research 
 
 
 

 
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2 
Date 
Version 
Modifications 
5/23/18 
v2.1 
Modifications were made to update the protocol with new measures for the 
cohort study, change in age inclusion criteria from 50 to 45, and change of the 
paper version to a phone version (based on feedback from the community 
organizations).  
1/31/19 
V2.2 
Modifications were made to project 3, adding a key informant interview option 
for the qualitative research to expand potential recruitment.  
11/13/19 
V2.3 
Peer support was removed from Projects 3 and 4 based on program adaptation 
study results. Updated outcome measures for Project 4 based on updated cohort 
study measures (including HRS supplemental questions and fall outcomes). 
07/21/2020 V2.4 
Updated consent process for Project 4 to include e-consent protocol. Updated 
outcomes for Project 4 to include the Falls prevention strategy survey and 
Participation frequency and importance self-efficacy scale based on the 
adaptation process. Added $5 compensation for reporting falls in Project 4. 
Updated research description of Project 4 based on adaptation results (inclusion 
of the Home Hazard Removal Program).  
 
Added supplemental COVID-19 survey measures.  
 
Updated recruitment status for Projects 2-4. Updated actual date of first 
enrollment from projected dated.  Copy-edited for clarity.  
 
12/15/2020 V2.5 
Updated questions included in Project 2, Year 3 to include COVID-19 history.  
2/1/2021 
V2.6 
Updated to add paper consent option for Project 4 due to REDCap IT issues with 
consent signature uploads.  
8/18/2021 
V2.7 
Updated to add analysis of recordings of the quarterly CBRN meetings and focus 
groups with CBRN members for Project 1. Updated statistical analysis plan for 
Project 2 based on revised outcome measures. Updated Project 3 as closed to 
recruitment. 
1/24/22 
V2.8 
Added member check with waitlist control group. Added questions about 
participants’ COVID vaccination status.  
8/18/23 
V2.9 
Added personnel and project 5 HARP CBRN 
 
 

 
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3 
Co-Authors: 
Susan Stark, PhD, OTR/L 
Program in Occupational Therapy 
Washington University School of Medicine 
 
Kerri Morgan, PhD 
Program in Occupational Therapy  
Washington University School of Medicine  
 
Marian Keglovits, OTD, MSCI, OTR/L 
Program in Occupational Therapy 
Washington University School of Medicine 
 
Emily Somerville, MSOT, OTR/L 
Program in Occupational Therapy 
Washington University School of Medicine 
 
Jessica Dashner, OTD, OTR/L 
Program in Occupational Therapy 
Washington University School of Medicine 
 
Michelle Putnam, PhD  
Simmons College, School of Social Work 
 
Aimee Wehmeier, MBA  
Paraquad, Inc 
 
Yan Yan, MD, PhD 
Division of Biostatistics 
Washington University School of Medicine 
 
Rebecca Bollinger, OTD, OTR/L 
Program in Occupational Therapy 
Washington University School of Medicine 
 
Brianna Holden, MSOT, OTR/L 
Program in Occupational Therapy 
Washington University School of Medicine 
 
 
 
 
 
 
 

 
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4 
WORLD HEALTH ORGANIZATION DATA SET 
 
Primary Registry and 
Trial Identifying 
Number 
ClinicalTrials.gov:  
Date of Registration  
 
Secondary Identifying 
Numbers 
IRB ID#: 201710186 
Source(s) of Monetary 
Support 
 
National Institute on Disability, Independent Living, and 
Rehabilitation Research 
Primary Sponsor 
 
Program in Occupational Therapy - Washington University School 
of Medicine in St. Louis, MO 
Secondary Sponsor(s) 
 
N/A 
Contact for Public 
Queries 
 
Susan Stark, PhD, OTR/L 
sstark@wustl.edu 
314-273-4114 
Department of Occupational Therapy 
Washington University School of Medicine 
5232 Oakland Ave 
St. Louis, MO 63110 
United States  
 
Contact for Scientific 
Queries 
Susan Stark, PhD, OTR/L 
sstark@wustl.edu 
314-273-4114 
Department of Occupational Therapy 
Washington University School of Medicine 
5232 Oakland Ave 
St. Louis, MO 63110 
United States  
 
 
Public Title 
 
Increasing Community Participation for Individuals Aging with a Long-
Term Physical Disability 
Scientific Title 
 
NA 
Countries of 
Recruitment 
United States 
Health Condition(s) or 
Problem(s) Studied 
 
PAwLTPD acquired prior to age 18 (e.g. Cerebral Palsy, Muscular 
Dystrophy) and those who acquire disability in adulthood (e.g. 
stroke, limb loss).  
 

 
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5 
Intervention(s) 
 
Home Modifications  
 
 
 
Key Inclusion and 
Exclusion Criteria 
 
PAwLTPD acquired prior to age 18 (e.g. Cerebral Palsy, Muscular 
Dystrophy) and those who acquire disability in adulthood (e.g. stroke, 
limb loss) 
Study Type 
 
Project 4 Testing preliminary efficacy of a program to reduce 
barriers to community participation. 
Translational Trial 
Phase I 
Allocation: Randomized 
Intervention model: Parallel Assignment 
Primary purpose: Community reintegration  
 
 
Date of First 
Enrollment 
 
November 3, 2020 
Target Sample Size 
 
50 
Recruitment 
Status 
 
Project 4, closed to recruitment  
Primary Outcome(s) 
 
Project 4 Testing Preliminary Efficacy of a Program to Reduce 
Barriers to Community Participation: 
We will test the working hypothesis that an adapted program, 
focused on resolving environmental barriers and building self-
management skills in the home and community, will be feasible 
and superior to usual care for daily activity performance and 
participation outcomes. The hypothesis is based on our previous 
work,2,3 the work of others,4-6 and our unpublished preliminary 
data. 
Aim 1. Determine the acceptability and feasibility of the adapted 
program. We will conduct a process evaluation7 of this intervention 
to evaluate the acceptability and feasibility and to aid in the 
interpretability of the trial. We will test the hypothesis that the 
adapted program will have high acceptability (80% retention), high 
fidelity by therapists (95% of elements and 90% of dose 
delivered), low safety risk (no increased rate of falls or health care 
use compared with control group), and high adherence (80% of 
modifications in use) at 6 months. 
Aim 2. Estimate the magnitude of efficacy of the adapted program 
on the primary outcome of community participation (RNL) and on 
exploratory outcomes of daily activity performance and self-
efficacy (I-HOPE) to select optimal end points for a large 
pragmatic trial. We will test the hypotheses that the adapted 
program is superior to usual care at 6 months on the primary and 
secondary end points.  
 
 
Time Points of Interest: Baseline, 1 month 

 
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6 
 
 
 
 
 
ORGANIZATIONAL STRUCTURE AND RESPONSIBILITIES 
Principal Investigator:  
Susan Stark, PhD, OTR/L 
 
Responsibilities include:  Managing the operations of the study, ensuring tasks are completed, ensuring 
compliance with quality-assurance requirements (e.g., human participant protection), preparing interim 
reports, and publication of study reports. 
 
 
Study Coordinators:  
Brianna Holden, MSOT, OTR/L and Rebecca Bollinger, OTD, OTR/L 
 
Responsibilities include: Developing all study materials including the Manual of Procedures and study 
forms, verifying informed consent from each participant, reporting Adverse Events (AEs) and Serious 
Adverse Events (SAEs), recruiting, screening, and enrolling of participants, randomizing participants; 
following and scheduling participants through study completion, protecting participants’ rights, submitting 
documents to regulatory bodies, developing and implementing quality control procedures, liaison with 
community partners. 
 
 
Data Management Committee:  
Susan Stark, PhD, OTR/L 
Yan Yan, MD 
 
Responsibilities include: Statistical design of study, data verification, developing and implementing data 
management procedures including the data flow and procedures for data entry, error identification and 
correction, preparing quarterly reports-enrollment, participant status (e.g., withdrawals), adverse events 
independent safety monitoring body reports. 
 
 

 
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Abstract  
 
Background. People with long-term physical disabilities are living longer and experiencing the challenges of 
aging, including the onset of secondary and age-related chronic health conditions. This group is at a high risk 
of diminished functional abilities and compromised participation. The aging of a population of people with 
disability poses new challenges for Long Term Supportive Service (LTSS) providers that have traditionally 
addressed either aging or disability service needs, but not both. People aging with long-term physical disability 
(PAwLTPD) are facing serious gaps in service delivery to support aging-in-place and community living in later 
life. The nexus of aging and disability and associated risk of dependence will continue to grow as the older 
population and number of people with long-term disabilities surviving to midlife and beyond increases.  
 
Purpose. We propose a Disability and Rehabilitation Research Program (DRRP) devoted to identifying and 
addressing barriers to successful community participation for people aging with long- term physical disabilities.  
 
Target populations. PAwLTPD acquired prior to age 18 (e.g. Cerebral Palsy, Muscular Dystrophy) and those 
who acquire disability in adulthood (e.g. stroke, limb loss).  
 
Goals. The purpose of the proposed DRRP is to conduct a pilot randomized controlled trial to evaluate the 
feasibility, fidelity and preliminary efficacy of an adapted intervention to address function and community 
participation for the new target population using the RE-AIM framework as the first program for dissemination 
and use within our previously developed Community Based Research Network (CBRN). The CBRN is a 
regional collaborative of centers for independent living (CILs), area agencies on aging (AAAs), and academic 
researchers. 
 
Proposed Methodological Approach. We will examine the feasibility of implementing the adapted EB program 
in the CBRN established under a previous project.   
 
Outcomes. This DRRP will expand the portfolio of EB programs that are effective in moderating the negative 
consequences of aging with disability on participation, and community living. 
 
 

 
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Background 
 
The United States is facing an unprecedented demographic shift. Older people are living longer and will 
constitute one-fifth of the population by 2040.8 People with long-term physical disabilities are also living longer 
and experiencing the challenges of aging.9,10 Chief among these challenges is the onset of secondary and age-
related chronic health conditions9 that can further undermine functional abilities and compromise participation, 
placing them at risk of “premature aging.” 11,12 The aging of a population of people with disability poses new 
challenges for service networks that have traditionally addressed either aging or disability service needs but 
not both.13-16 People aging with long-term physical disability (PAwLTPD) who need a holistic service approach 
are placing new demands on long-term supportive services (LTSS) providers17 and spotlighting serious gaps in 
service delivery to support aging in place and community living in later life for PAwLTPD. This growing 
segment of our population has the potential to fall through service gaps at alarming rates.14 If this group is able 
to access services, they are less likely to receive evidence-based (EB) interventions, as few have been 
evaluated for effectiveness for this emerging population. The PAwLTPD population is significantly 
understudied, as is the issue of participation in later life.18 We propose to address this critical gap in knowledge 
between the traditionally distinct bodies of aging and disability research and services to improve the lives of 
people aging with long-term disability (PAwLTPD) and to support their ability to participate in the community in 
later life. 
 
We have designed an innovative program of research and knowledge translation that bridges the fields of 
aging and disability to establish an integrative and collaborative network of researchers and practitioners aimed 
at improving community participation for people aging with physical disability.19 Central to our program is the 
application of effective translational research methods designed to increase the availability of EB practices for 
PAwLTPD combined with the creation of a self-sustaining community-based research network (CBRN) that 
includes both aging and disability partners (modeled after successful practice-based research networks 
[PBRNs]). The network will serve as both a test bed for identifying issues and determining the efficacy and 
effectiveness of new programs and a platform for disseminating and implementing new EB programs. 
Translational research methods will be used to guide the adaptation of existing highly effective EB programs 
developed for older adult populations experiencing disability and to test their efficacy for PAwLTPD in 
community settings. This transformational community-engaged research agenda will link bodies of research, 
service providers, and key stakeholders to tackle a looming crisis in the availability of effective community-
based services for PAwLTPD.  
 
Target Population and Statement of the Problem: 
Aging with long-term disability.  
 
Over the next 3 decades, the United States will experience considerable growth of its older population. By 
2050, the population aged ≥65 years is projected to double as surviving baby boomers reach age 85.20 
Advances in medicine and public health are associated with the demographic shift to an aging society. 
Improvements in health have translated into increased longevity. People with disabilities (now nearly 13% of 
our population21) have also benefitted from these medical advances and are living longer.22 Aging with a 
disability refers to the subset of people with lifelong and early onset disabilities such as cerebral palsy, post-
polio syndrome, spinal cord injury (SCI), and muscular dystrophy, to name just a few, who are surviving into 
mid- and later life.13,23 The phrase aging with disability can also be applied to people who acquire disabilities in 
midlife due to limb loss and stroke or disabling conditions such as diabetes and multiple sclerosis and who are 
also increasingly surviving into later life.24  
 
Although differences are associated with the severity of an injury or health condition, people with physical 
disabilities now have nearly normal life spans.25-30 While estimates vary with different definitions of disability, 
the best available estimates suggest about 12 million people older than 65 years are aging with early onset 
disabilities.13,31,32 What is clear is that, with increasing age (beginning at 45 years), people with disabilities 
report greater difficulty with independent living.22 People aging with early and midlife onset of physical disability 
are at risk for all common age-related impairments and chronic conditions that threaten the health and 
independence of the general middle-aged and older population. These include hypertension, heart disease, 

 
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diabetes, arthritis and other musculoskeletal disorders, falls or other injuries, obesity, depression, and cognitive 
decline.33,34 People with long-term physical disabilities experience these conditions earlier than their 
nondisabled counterparts, and that may have a greater impact on functional abilities.35 PAwLTPD 
simultaneously may confront “secondary conditions” associated with their primary disabling condition. 
Depending on the type of disabling condition, secondary conditions can include accelerated aging of organ 
systems,36,37 pain,38-40 fatigue,41,42 weakness,42 pressure ulcers,30,43 urinary tract infections,30,43 and bladder or 
bowel dysfunction.42,44 We have discovered aging-related changes in ability, and secondary health conditions 
can be more disabling and affect independence and community participation more than the primary disability 
itself among people with early and midlife-onset disability.45  
 
As personal abilities change with the aging process, PAwLTPD face increasing barriers to independence and 
community participation, yet there is a paucity of evidence on aging successfully with a disability.46 In a 
secondary analysis47 of a cohort study conducted by Gray et al45,48 of 604 people with long-term mobility 
impairments, we discovered PAwLTPD aged 50-65 years had significantly lower participation rates than those 
aged 18-49 years, as measured by the Facilitators and Barriers Survey of environmental influences on 
community participation. Strikingly, participants in the 50-65 age cohort had participation patterns similar to 
adults aged ≥65 for all destinations (eg, dining out, visiting friends, volunteering or working, shopping) except 
going to church or the pharmacy. It appears that community participation degradation patterns are similar to 
other trajectories of functional decline12 for people aging with disability. It is unknown if intervening to remediate 
environmental barriers to community participation for people early in the aging process is an effective 
mechanism to reverse the negative participation trajectory for this population.  
 
A fragmented LTSS delivery system has resulted in a gap in community-based services for PAwLTPD who 
wish to age in place. More adults with significant disabilities are living in the community as states comply with 
the Supreme Court decision Olmstead v. L.C., 527 U.S. 581,49 requiring community options to be available to 
those who need LTSS. LTSS includes a broad range of paid and unpaid medical and personal care assistance 
that people may need when they experience difficulty completing self-care tasks as a result of aging, chronic 
illness, or disability.50 Two nationwide community-based service networks offer LTSS: Centers for Independent 
Living (CILs) and Area Agencies on Aging (AAAs). LTSS offered by CILs generally targets people with 
disabilities but are not typically focused on issues of aging. LTSS offered by AAAs tends to focus on issues of 
aging and disability but do not have an independent living lens or emphasis on participation. PAwLTPD are a 
“crossover” population that potentially qualifies for both aging- and disability-related assistance and supports 
but often does not fit neatly into either service network’s model of LTSS. Although both agencies serve 
PAwLTPD, they may not have programs or services that can accommodate this population’s unique issues. It 
is unclear how well either type of organization is prepared to provide services to this growing population. 
Pending changes in the Affordable Care Act51 and Medicaid funding52 suggest that cross-network 
collaborations between CILs and AAAs may be more urgently needed to support people with disabilities to live 
in the community at all ages.  
 
The nexus of aging and disability and associated risk of dependence will continue to grow as the older 
population and the number of PAwLTPD surviving to midlife and beyond increase.23,53 Because the PAwLTPD 
population is relatively new to both disability and aging service providers, no formal definition of this population 
exists. For the purposes of this study, we will focus on PAwLTPD12,13 at greatest risk for losing their 
independence in the community. We will target PAwLTPD aged 50-65 years who are at high risk of reduced 
community participation. 
 
There is a paucity of EB LTSS programs demonstrating effectiveness in facilitating independence and 
community participation for PAwLTPD. Emerging evidence points to the importance of community participation 
for successful aging with a disability.46 Yet, no EB programs that address participation and aging in place have 
been demonstrated to be effective for PAwLTPD. Although promising programs exists for improving health 
outcomes of PAwLTPD (see “Living Well with a Disability”54,55), LTSS providers have an urgent need for 
rigorously tested programs for PAwLTPD. The Administration on Community Living places a strong emphasis 
on developing and funding EB practices among AAAs and has published rigorous standards for defining what 
is an EB practice; however, to date, few meet these criteria.56 For LTSS providers to effectively meet the needs 

 
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10 
of PAwLTPD, EB programs must be developed and deployed to community agencies such as CILs and AAAs.  
 
PAwLTPD have distinctive characteristics that vary by the nature of diagnosis, impairment, and disability.57,58 
The development of appropriate fall prevention programs, for example, may be needed for persons with MS, 
who have a higher likelihood of falling than do persons aging without disability.59 People with physical 
disabilities, however, are generally excluded from efficacy studies. There is a lack of translation of evidence 
from either disability or gerontology and rehabilitation to the unique needs of PAwLTPD.53 We intend to help 
address this problem. 
 
Research Activities Overview 
We will examine the feasibility of implementing an adapted EB program targeting function and community 
participation in the CBRN established under a previous project. Our prior projects and their relationship to the 
current study is presented in Figure 
1. In brief, our previous work 
established a regional CBRN 
consisting of a mix of CILs and 
AAAs that represent urban and 
rural communities and serve a 
diverse population. Members of this 
CBRN participated in a series of 
focus groups and key informant 
interviews with key stakeholders 
(PAwLTPD and service providers) 
to identify elements to be adapted 
from EB interventions targeting 
function and community 
participation. This adaptation forms 
the basis of this study which aims to 
test the feasibility of this adapted 
program with PAwLTPD. 
 
Methods 
 
All methods will be implemented according to the proposed study timeline, with revisions as necessary.  
 
IRB Revisions and Compliance: Updates to the IRB will be submitted during the planning process for each 
new component of the research project. Necessary IRB updates (i.e. uploading new or revised study collection 
instruments, study flyers) will be reviewed by the PI and research coordinator during weekly study team 
meetings. The research coordinator will be responsible for updates to the protocol and modifications to the IRB 
throughout the study as individual projects begin. All necessary study team members will be informed of 
proposed and accepted revisions. Human research approval will be obtained from Washington University prior 
to enrollment of any research participants for each study project. 
 
Research Design Overview  
 
Adapt an Evidence-Based Intervention for Delivery: 
Adaptation: We will conduct a series of focus groups and key informant interviews and use the findings in 
combination with findings from our prior cohort study to iteratively adapt COMPASS. We will use community-
engaged research approaches,62,63 involving key stakeholders as part of the research team, and an adaptation 
framework64 to adapt the program for delivery in the Independent Living and Aging Services Network.65 
 
Figure 1. Study Overview 

 
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Next, we will adapt the program pragmatically and culturally for delivery within existing CILs and AAAs. To 
accomplish this aim, we will use the Cultural Adaptation Process (CAP) 66 model and community-engaged 
research techniques to adapt the program while maintaining the essential elements of the intervention. CAP 
incorporates the voices of the community, providers, and treatment developer in all stages of adaptation.64 64 
The RE-AIM framework67 is designed to expand the assessment programs68 to translation and public health 
impact. Although this is not a dissemination study, we will use RE-AIM to ensure that the final intervention has 
the greatest potential for future implementation and dissemination 
(Figure 2). We will use the framework to guide adaptation of the 
intervention.68 We will use the ecological validity model69 to 
document the changes.  
 
 
Testing Preliminary Efficacy of a Program to Reduce Barriers 
to Community Participation: 
We will conduct a trial to reduce the “science to service” gap using 
the CBRN.70,71 Hybrid designs examine efficacy while conducting a 
process evaluation of an intervention.72 We anticipate that a hybrid 
approach will lead to more rapid translational gains in intervention 
uptake, more effective implementation strategies, and more useful 
information for decision makers. We will facilitate translation by 
“designing for implementation and dissemination”73 to ensure that 
findings are useful, relevant, and ready for widespread 
dissemination.74 We will use the RE-AIM framework67 (Figure 2) 
to adapt the intervention, to design the trial, and to plan for 
potential future dissemination through the CBRN.75 Cost is an important factor that influences decisions and 
uptake of interventions.76 To evaluate potential for implementation, we will examine costs to deliver the 
intervention, with engagement of CBRN members. This approach will provide CBOs with a better 
understanding of the impact of an intervention and incorporate RE-AIM metrics to aid in understanding the 
translation and sustainability of the program. 
 
Study Participants 
 
Recruitment 
The eligibility criteria include (1) age 45-65 years; (2) self-report of difficulty with ≥2 daily activities using the 
OARS ADL scale81; and (3) onset of a physical disability 5 years prior to participation (eg, SCI, cerebral palsy, 
post-polio syndrome, stroke, amputation). We will exclude those currently institutionalized. 
 
To ensure that the sample represents people that this program will target in the future (reach),82 we will select 
a sample of 50 adults aging with a long-term disability from the St. Louis members of the CBRN or who have 
participated in our previous cohort study of PAwLTPD. The CBRN offers access to PAwLTPD who are hard to 
reach in the traditional health care system and who could benefit from the intervention. In the current cohort of 
SLAAA participants, 2526 are aged 45-65 years (people with disabilities). Paraquad serves 420 people with 
physical disabilities aged 45-65 years who meet the eligibility criteria. We will invite eligible participants to 
participate by telephone. All recruitment and study materials will be IRB approved. 
 
 
Randomization and Blinding 
Participants will be allocated using a 1:1 ratio by block randomization sequences generated a priori using a 
computerized probability model. The allocation ratio will be maintained at periodic intervals. Groups will be 
balanced for race and sex. Randomization sequence concealment will be achieved by research electronic data 
capture (REDCap)83 after baseline assessment.  
 
 
Consent 
Figure 2. RE-AIM framework used to 
adapt the program  

 
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All potential participants will be screened by trained staff using a script.  Screening will take place in person or 
over the phone. Potential participants will be given a copy of the large print informed consent document and a 
study review sheet written at an appropriate reading level. During screening, all participants will: (1) have a 
detailed explanation of the study and what is expected of them; (2) discuss potential problems that could 
interfere with participation; (3) have their questions answered; and (4) receive a large print summary of the 
study and contact information for the PI and study coordinator. Consent will occur before the baseline visit. A 
study team member will call all potential participants and will screen for inclusion criteria and invite them to 
participate in the study. The informed consent form will be explained over the phone to all potential participants 
interested in participating in the study. For potential participants who have computer access and capability, the 
formal study consent process will be conducted using a REDCap-based electronic consent form. The consent 
form has been developed in REDCap, a secure, web-based HIPAA-compliant, data collection platform with a 
user management system allowing the PI to grant and control varying levels of access to study staff. Potential 
participants would receive an email with a unique link to review the informed consent form online. After the 
research team explains the study and answers any question, the potential participants can electronically fill in 
an "Agree" button, followed by their electronic signature. Upon completion of the consent, participants are 
presented with the option to download a copy of the executed form. The research team will provide a copy of 
the executed form to the participant at the baseline visit if requested. E-consent versioning will be managed 
using the e-consent Framework in REDCap. Within the e-consent survey options, we have designated the e-
consent version number in this application as e-consent version 1. The PDF's of completed responses will 
have the timestamp, participant name, and e-consent version number inserted in the footer. Future versions of 
the e-consent will be created by making a copy of the REDCap form and revising it. The old version would be 
de-activated upon receiving IRB approval for the new version.  
 
If a participant does not have access to a computer or smart device at the time of consent potential participants 
will be provided with a copy of the informed consent in person or via US mail.  Once the potential participant 
has had time to look over the consent form, a study team member will talk with the participant by phone to 
review the study information and answer any questions. If they decide to participate, they will be asked to sign 
the electronic version of the consent using a study provided iPad at the baseline visit. If e-consent is 
unavailable, paper versions of the consent form will be used and signed either via US mail or in person at the 
baseline visit. We will email a copy of the consent form if the participant has a valid email address, otherwise 
we will download a copy and provide it to the participant. Participants will be advised in the consent form that 
there is a possibility that their medical research record, including identifying information, may be inspected and 
photocopied by officials of federal or state government agencies and the Washington University Human 
Research Protection Office (HRPO).  
 

 
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13 
Research Project Descriptions 
We propose adapting an effective program 
designed to remove barriers in the home and 
community. COMPASS is a complex intervention 
that combines 2 EB treatment strategies. The 
program will be adapted culturally and 
pragmatically. Based on preliminary data, we 
anticipate that changes to the program will include 
delivery of self-management training for 
community participation and process modifications 
to fit the existing AAA90 and CIL91,92 program 
structure. The essential elements will be 
maintained.  
 
Based on the results of previous focus groups, we 
have added additional elements to the proposed 
intervention to address fall prevention for 
PAwLTPD. An evidence-based fall prevention 
program, Home Hazard Removal Program (HARP) 
was identified and integrated into the new 
program, Removing Environmental Barriers to 
Independent Living (REBIL). HARP is based on 
the Westmead approach93 and has been shown to 
be effective in reducing falls in the home for older 
adults living in the US. 
 
Defining the treatment (Table 1). The treatment 
theory guiding the intervention is a competence-
press model that posits that removing 
environmental barriers and hazards and adding 
supports (eg, grab bars near the toilet, using 
accessible transportation) matched with the 
PAwLTPD’s unique abilities and limitations will 
improve the outcome of daily activity performance, 
safety, and participation.94 The 2 essential 
components95 of REBIL are (1) removing 
environmental barriers and home hazards and (2) 
strategy training. Both address barriers in the 
participant’s own home and community environment.96 Independence at home is addressed first. To remove 
barriers in the home, a tailored home modification intervention is provided.97-99 Tailoring is necessary, given the 
heterogeneity of participants and environments.100 Strategy training will facilitate long-term effects of the 
intervention by providing PAwLTPD self-efficacy to problem-solve emerging barriers to participation.  
 
Table 1. Program elements 
Dosage and 
timing 
One assessment session; four 75-
minute visits in the home with OT (over 
8 weeks) 
Model/Theory 
ICF model; Competence-Press theory 
Two 
Components 
(evidence- 
based 
strategies) 
 
 Home modifications and hazard 
removal (OT) 
• Assessment  
• Participants ID problems in the home 
• Tailored home modifications and 
hazard removal; shared decision 
making to select solutions 
• Active Practice in context  
 
 Strategy training (OT) 
• Participant identifies barriers and 
resources 
• Encourages self-efficacy 
Approach 
• Dose of home modification and 
hazard removal begins high and 
tapers; dose of strategy training begins 
low and increases 
• Clinician as partners; caregivers 
included 
Standardized 
elements of 
tailored 
approach 
• ID up to 10 in-home problematic 
activities 
• ID home hazards 
• ID 3 solutions (for each in-home 
problem) 
• Implement selected solutions in-
home 
• In-context training, active practice 
• ID 2 problematic community activities 
• Self-management to resolve 
community barriers 
ICF=International Classification of Functioning, 
Disability, and Health; ID=identify; OT=occupational 
therapist. 
 

 
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The conceptual model of the intervention (Figure 3). The ICF describes the mechanism of the adapted 
program. PAwLTPD have a health condition that affects their body structure and function. The home and 
community environments of PAwLTPD pose 
barriers that prevent successful and safe 
performance of daily activities and participation. 
Intervening to remove barriers and enable 
PAwLTPD to use problem-solving strategies to 
overcome barriers will improve daily activity 
performance and participation outcomes. This 
conceptual model is empirically supported by our 
recent work exploring the role of environmental 
barriers in function.101 
 
Baseline Home Visit (T1) for all Participants  
Outcomes (primary endpoints described in Table 
2) will be assessed by blinded evaluators at 
baseline and 6 months. Additional exploratory 
outcome measures are listed under the 
assessments section.  
 
Baseline and 6-month follow-up assessments will 
be conducted in the home by a trained and 
certified rater blinded to group allocation. Follow-
up assessments will be completed by a blinded 
rater who did not conduct the T1 evaluation, as 
new home modifications could reveal group assignment.  
 
Intervention 
The occupational therapists will deliver the final 
adapted program in each participant’s home and 
community. The essential elements include 
resolving barriers in the home and community and 
self-management skills to identify and resolve 
barriers. The intervention will target barriers in the 
home initially. Participants will identify target 
activities they want to address. Although problem 
areas addressed are participant-specific (tailored), 
the process to identify and address the problems is 
systematic and reproducible. All participants will 
receive identical intervention components (see 
Table 1). 
 
Waitlist Attentional Control Treatment. The waitlist 
control group will receive the adapted program after 
the 6-month follow-up is completed. Participants in 
the waitlist control group will receive interview visits 
(equivalent in time by an occupational therapy 
graduate assistant). After the six-month follow-up 
has been completed, participants in this group will be contacted and asked to participate in a validity check. 
They will then be offered treatment at the end of the follow-up period.  
 
Follow-Up Periods  
Table 2. Measures: Primary End Points and Rationale for 
Inclusion 
Reintegration 
to Normal 
Living Index 
(RNLI)48,102-105  
 
The RNLI measures the extent to which a 
person is able to complete normal life 
activities. The 11-item measure quantifies 
participation. The administration of the RNLI 
is quick and simple. Individual item scores 
are converted to 100. The RNLI can be 
administered in person or by mail.  
In-Home 
Occupational 
Performance 
Evaluation 
(I-HOPE) 106 
 
The 
I-HOPE 
is 
a 
performance-based 
assessment 
that 
can 
measure 
the 
performance of the environmental barriers 
that influence 42 activities performed in the 
home (person-environment fit).The tool also 
has a self-efficacy subscale that measures 
confidence 
performing 
activities. 
The 
instrument yields 4 subscales with high 
internal reliability (α = 0.77–0.78) and 
interrater reliability (0.94 to 1.0).106 The I-
HOPE 
will 
yield 
home 
assessment 
information and outcome activity performance 
assessment 
Figure 3. Adapted program conceptual model adapted from the 
ICF. Blue boxes represent intervention. Blue lines and green 
boxes represent the hypothesized mechanism of action. By 
reducing environmental barriers, activity and participation 
outcomes will improve. 

 
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6-month follow-up assessments will be conducted in the home by a trained and certified rater blinded to group 
allocation. Follow-up assessments will be completed by a blinded rater who did not conduct the T1 evaluation, 
as new home modifications could reveal group assignment. 
 
 
Program Revisions 
Based on data from our prior cohort study and  focus groups, we will produce adapted program materials that 
maintain the “essential ingredients” of the program but are culturally tailored and deployable within the limits of 
current CILs and the Aging Services Network. We will develop a new set of materials including procedures and 
an interventionists’ manual. 
 
To ensure fidelity to the original program, draft materials will be reviewed by Dr. Stark (developer of the original 
program) to ensure that the “essential elements” are maintained in the program. We will use the ecological 
validity and sensitivity framework 69 to document changes.  
 
The new program will be iteratively piloted with 3-6 individuals living with a long-term physical disability. The 
pilot participants will identify potential problems with acceptability of the program structure or process and 
information delivered to the participant. The program will be iteratively revised until a final program is 
sufficiently ready to deploy in a larger sample.  
 
Outcomes will be assessed by blinded evaluators at baseline and 6 months. Our goal is to optimize the design 
of future trials, so we will examine a series of measures to evaluate their utility in the trial setting. Baseline and 
6-month follow-up assessments will be conducted in the home by a trained and certified rater blinded to group 
allocation. Follow-up assessments will be completed by a blinded rater who did not conduct the T1 evaluation, 
as new home modifications could reveal group assignment. We will also track falls on a monthly basis.  
 
Assessments 
Primary Outcomes 
In-Home Occupational Performance Evaluation (I-HOPE): The I-HOPE will be used to measure current activity 
patterns of participants, identify activities that are difficult but important to them, and identify the environmental 
barriers that influence those activities (person-environment fit). The I-HOPE is a multi-step assessment that 
evaluates the performance of people doing 42 activities in the home. Using labeled pictures of each home 
activity (e.g., washing dishes, getting in and out of bed), participants identify and prioritize preferred activities for 
intervention and give a subjective performance, satisfaction, and self-efficacy score for each activity.  A trained 
rater (e.g., OT) observes the participant perform the activity and quantifies the person-environment fit (or misfit). 
The instrument yields five subscales- the activity subscale [α = 0.78 (6 items)]; performance subscale [α = 0.85 
(8 items)]; satisfaction subscale [α = 0.77 (8items)]; self-efficacy subscale [α = 0.90 (10 items)]; and the 
environmental barrier subscale [α = 0.77 (6 items)]. Intraclass correlation coefficients were calculated for the I-
HOPE subscales on a sample of 10 participants, and scores ranged from .94 to 1.0 for raters.141  
Reintegration to Normal Living Index (RNLI): The RNLI is a disability-related quality-of life-instrument that will 
be used to measure participants’ satisfaction with their home and community participation and has been 
validated on a population of community-dwelling individuals with chronic conditions.142 Participants will read 11 
statements relating to their monthly activity patterns and assign each one a score based on a 10-point ordinal 
scale with 1 indicating “does not describe my situation at all” and 10 indicating “fully describes my situation.” 
Participants will complete the RNL at home and return it by mail.  
Westmead Home Safety Assessment (WeHSA)93:  The Westmead Home Safety Assessment will be used to 
identify the number of environmental hazards in all areas of the home (e.g., seating, bedroom, medication 
management) via 72 standardized categories. Each category is specified with explicit descriptors to qualify a 
given fall hazard with a score of 0 for absent and 1 for present.  Total hazards are summed. A trained rater will 
complete the assessment at baseline and at the 6-month follow up. 
 
Exploratory Outcomes 
Health and Retirement Study1 (HRS) Activity Supplement 2015: The Health and Retirement Study is a 

 
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longitudinal study designed to address important questions on the challenges and opportunities of aging. The 
activity supplement questionnaire will be used to provide descriptive information on activity participation. 
Modifications have been made to allow for additional qualitative responses describing barriers and limitations 
to activities.  
Falls prevention strategy survey (FPSS): The FPSS is a self-report instrument addressing protective behaviors 
related to fall risk among adults.143 Response options reflect the frequency with which the respondent engages 
in twelve different fall prevention behaviors behavior (never, sometimes, regularly). 
Participation frequency, importance and self-efficacy: The participation frequency, importance and self-efficacy 
measure address four areas of participation: routines, recreation, responsibilities and relationships.144 Twenty-
five different activities are rated by the participant on a 1-5 Likert-type scale in the areas of frequency, 
importance, and self-efficacy to complete the activity.  
Falls: Calendars reporting falls and health care utilization will be collected monthly via REDCap survey (using 
an automated system and/or in person). 
Covariates 
Demographics: Basic demographic information will be collected for all participants. Information collected will 
include age, race/ethnicity, sex, gender identity, marital status, level of school, primary disability, use of a 
mobility device, and living arrangement. 
Bayliss Comorbid Conditions: The Bayliss is a multimorbidity scale that assesses the impact of different 
conditions on daily activities as a measure of disease severity, conceptualized as self-reported disease burden. 
This scale was designed in order to create a subjective measure of comorbidity, to be used especially in 
studies using QoL outcomes, where the patient’s perception plays an important role.118-120  
 
Process Evaluation 
Reach. Enrollment and retention will be tracked by the research coordinator using REDCap, an online data 
entry program. Recruitment information for each participant will include the potential participant’s initials, 
gender, birthdate, race, zip code. Reasons for denying participation in the study as well as study attrition will 
also be tracked via REDCap.   
Fidelity. In order to guarantee treatment fidelity, or our ability to provide the same treatment as planned to each 
participant, we will use a Session by Session checklist following similar methods of Weersing et al.145 This grid 
specifically outlines the pre-, during, and post-treatment visit requirements for each treatment session. It is 
designed to be a checklist in which therapists check off the action once it is completed. During weekly 
interventionist meetings, the lead therapist will review the treatment grid for each participant to guarantee the 
necessary components of the intervention are being delivered. A fidelity checklist designed to assess therapist 
adherence and competence in delivering the treatment intervention will also be used.146  
Dose. In order to effectively measure the dose of treatment provided for each participant, we will measure both 
the dose that was delivered to each person (minutes of each treatment session and number of session) as well 
as the dose received (recommendations implemented/total recommendations). We will use a spreadsheet or 
Time Log to track minutes spent in each treatment session and another spreadsheet or Prescription Log to 
track the recommendations made and implemented for each participant.  
Adherence. Adherence measures the participant’s continued use of the implemented modifications. We will 
use the standardized approach of Cumming et al.147 to calculate adherence as recommendations used/total 
recommendations. Interventionists will rate adherence with intervention at the final session by using the 
Prescription Log to track recommendations made, implemented and reasons that any recommendations were 
not implemented. Initial adherence will be a proportion of the number of recommendations implemented 
/recommendations suggested. Finally, we will determine the number of recommendations 
used/recommendations suggested at 6 months. Reasons for abandoning strategies will be examined using the 
Adherence Log, in which the participant will report on current level of use for each modification: very useful, 
somewhat useful, not at all useful, no longer use equipment. Any independence that was regained by improved 
sensorimotor performance will not count against the adherence rating.  

 
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Cost. The cost of the treatment will be measured by tracking cost of modifications and adaptive equipment for 
each participant. This will be tracked using the Invoice Form which includes both costs from the contractor as 
well as costs of any equipment ordered from a medical supply company or obtained from a community 
resource (medical equipment lending program).  The total amount of money spent on each person will be 
tracked on this form.  
Safety. To explore the safety of our study, we will measure the number of falls and the circumstances 
surrounding the falls with a self-report Fall Form used at the 6 month follow up visit. The rate and severity of 
the falls will be calculated using a standardized algorithm established by Tinetti, et al, 1988.148 We will also 
track health care utilization for participants in both groups (# of emergency room and outpatient visits, # of 
hospitalizations, and number of days in therapy) using the Health Care Utilization Form. 
 
Process Evaluation 
 
The components and data sources 
of the process evaluation are 
presented in Table 4. We will 
conduct a process evaluation to 
understand the feasibility and to 
refine the components of the 
intervention in preparation for a 
definitive trial.162 We will monitor 
recruitment metrics for all eligible 
participants including demographic 
characteristics, enrollment status, 
and reason for decline. We will 
determine the fidelity of the 
intervention by determining whether 
the intervention was delivered as 
planned and calculating the dose of 
the intervention received by both groups (number of minutes and number of sessions delivered).  
Interventionists will rate adherence at last visit as the number of recommendations implemented per 
recommendations suggested.163 Long-term adherence will be calculated as the number of recommendations 
used at 6 months per recommendations suggested. We will examine reasons for abandonment of strategies. 
Environmental modifications are not provided as part of standard care in the United States; therefore, reliable 
cost data are not available. We will track the cost of service provision (in the treatment group) to prepare for 
future cost-effectiveness studies. We will record occupational therapist time to provide services (direct and 
indirect). The hourly wage of the contractor will be estimated using wage rates for the St. Louis area as 
reported by the US Bureau of Labor Statistics.164 All materials costs will be captured from invoices. Costs will 
be estimated from the payer perspective (eg, Medicare allowable will be used to estimate covered clinical 
encounters.)165 
 
Statistical Analyses 
First, we will examine the distributional characteristics of study variables (outcomes, covariates). Basic 
descriptive statistics for each measure and the intercorrelations among study variables will provide a simple 
initial view of the sample characteristics (demographic and health-related variables). Second, we will determine 
whether participants are representative of the eligible population by comparing baseline sociodemographic 
characteristics (eg, age, gender, education) of the study population with those eligible to participate in the 
study but who declined to participate. Continuous variables will be analyzed with the appropriate parametric 
methods (eg, t test) to test for differences between the participants in the study and those who refused. 
Discrete variables will be analyzed with the appropriate nonparametric test (eg, chi-square test of association) 
to test for differences between the participants in the study and those who refused.  
 
Table 4. Process Evaluation Construct Data: Source and Form 
Reach 
Enrollment; 
retention* 
Reason eligible not enrolled; 
recruitment rate; retention rate 
Fidelity 
Implemented per 
plan^ 
Session by session checklist of each 
component  
 
Dose delivered^ 
Minutes of treatment at each session; 
number of sessions 
 
Dose received^ 
Recommendations implemented/total 
recommendations 
Adherence 
Adherence to 
recommendations+ 
Recommendations used/total 
recommendations at 6 months; cause 
of abandonment 
Costs 
Costs^ 
Final prescription and invoice 
(materials); treatment grid (time) 
Notes: Data source *Recruitment coordinator; ^Interventionist notes; + 6- and 
12-month follow-up assessment. 

 
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Next, we will use unpaired t tests and chi-square tests to compare baseline characteristics in the 2 groups for 
descriptive information (except when statistical assumptions are not met, in which case we may use Wilcoxon 
or Fisher exact tests). We will examine the process data before the efficacy analyses.170 The goal of Aim 1 is to 
examine the feasibility of conducting a larger trial by conducting a process evaluation. We will conduct 
between-group comparisons of process end points collected at 6 months (eg, health care utilization rate, 
safety, dosage delivered, and adherence rate) using unpaired t tests or chi-square tests. We will compare the 
characteristics of patients that complete the assigned intervention to those who do not for differences in 
disability severity and comorbidities. Descriptive statistics will be used for costs per participant and adherence.  
 
The goal of Aim 2 is to test the hypothesis that the adapted program will result in greater improvements in 
participation and daily activity performance than control at 6 months after intervention. Mixed-model repeated-
measures analysis of variance will be used for longitudinal analyses of variables measured at >2 time points 
(ie, Reintegration to Normal Living Index, I-HOPE). The focus of this analysis will be the significance of the 
interaction between group and time. Hypotheses will test for interactions in terms of the equality of changes 
over time in the 2 groups. Contrasts will be used in testing the null hypothesis that changes between 2 specific 
time points in one group are equal to corresponding changes in the group. I-HOPE scores will be analyzed with 
analysis of covariance with the 6-month value as the dependent variable and the baseline value as the 
covariate. For all analyses, we will determine whether required distributional and model-specific assumptions 
are satisfied. To explore the potential trial end points, we will select the best independent indicator of 
participation and compare the measures for sensitivity and statistical efficiency with data collected at 6 months 
after intervention. 
 
Sample Size Calculations  
 
Although statistical significance is not the goal of this study, we estimated a sample size using a power analysis 
for a 2-sided, 2-sample, unequal-variance t test using G*Power with a significance level of 5% and power of 
80%.173 The sample size calculation includes a correlation between baseline and follow-up measures and is 
based on analysis of change scores, which is equivalent in efficiency to the proposed analytic model. Data were 
used from a pilot study with a total of 113 community-dwelling older adults.100  We estimated the sample size for 
the mechanism of action (reducing environmental barriers). Environmental barrier mean changes in intervention 
and control groups were 26.28 (SD 18.03) and 10.09 (SD 22.27), respectively. A sample size of 50 (25 in each 
group) is needed to provide 80% power. 
 
Potential Benefits, Risks and Alternatives 
Benefits 
All participants will receive a baseline assessment provided by a registered and licensed occupational 
therapist. In addition, all participants will receive the intervention at no cost. Participants will receive $5 for each 
month that falls are reported (waitlist control will receive the intervention after the 6 month follow-up is 
completed). Participants that participate in the COVID-19 pandemic survey will be entered to win a $50 gift 
card for each survey that is completed. 
 
Risks 
Potential risks of research participation (physical, psychological, financial and legal risks among others) are 
considered minimal in all the projects (45 CFR46.404). Minimal risk may be involved as the general data 
collection procedures involve participant interviews and questionnaires that are time consuming (for 
participants receiving the intervention, 90 minutes for the initial home assessment with follow-up visits at 6 
months) and may result in fatigue or aggravation. In addition, some questions may touch on emotionally 
sensitive issues that could cause anxiety or other forms of emotional stress. The performance-based testing (I-
HOPE) involves observation of everyday activities that may result in fatigue or embarrassment. Participants will 
be informed that their involvement in this research study is voluntary and that they may choose not to 
participate or withdraw their consent at any time. Withdrawal from the study will not affect the commitment of 
the community agency to administer care, and there will be no penalty or loss of benefits to which participants 
are otherwise entitled. Participants who undergo the study visits will be given the option to reschedule the visit 

 
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or take a break at any time during the study if necessary. All research-related information will be kept 
confidential and accessible only to authorized members of the research team. 
 
Minimization of Risks and Confidentiality 
Training and Compliance. All study personnel involved in the conduct of this research will receive the required 
education on the protection of human research participants prior to the funding of this project in accordance 
with the NIH policy. We are a HIPAA-covered entity and comply with all HIPAA regulations. To protect against 
and minimize potential risks, participants will be carefully screened and evaluated.  
Safety. To minimize the risk of a fall, participants will wear a gait belt during the in-home evaluation of 
performance. Participants will be trained in the use of all modifications by a licensed and registered OT.  
Participants (newly enrolled and those still receiving any in-person study-related visits will be asked their 
COVID vaccination status.  
Minimize discomfort. To avoid or minimize symptoms of fatigue, agitation, or emotional distress due to testing, 
participants will be instructed to notify the rater or interventionist if they experience any discomfort. They will 
also be periodically questioned about their tolerance for the tests/intervention. Testing and interviews will be 
terminated if participants develop fatigue, agitation, or emotional distress.  
Protect identifiers. An ID number will be assigned to each participant. All data collected from a participant will 
be labeled with the ID number. All participant electronic and hard-copy data will be kept under double-lock 
protection. All hard-copy forms that contain personal identifiers (e.g., name, address, phone numbers) will be 
stored in a separate locked file drawer under double-lock protection. No publication or presentation of the study 
data will uniquely identify or provide sufficient information to uniquely identify participants.   
To guard against unauthorized data access, all shared-use computer systems at Washington University School 
of Medicine are protected with passwords, which are changed at four-month intervals. Only individuals with a 
particular "need to know" status are given access, and system privileges are carefully restricted. All personal 
computers are located within a secure area, and the system is locked when not in use.   
      
For data entry (in the field or from paper forms), the Washington University Division of Biostatistics Informatics 
Core will be used as a central location for data processing. Washington University belongs to a consortium of 
institutional partners that work to maintain a software toolset and workflow methodology for electronic 
collection and management of research and clinical trial data. REDCap (Research Electronic Data Capture) 
data collection projects rely on a thorough study-specific data dictionary defined in an iterative self-
documenting process by all members of the research team with planning assistance from the Division of 
Biostatistics Informatics Core. REDCap servers are securely housed in an on-site limited access data center 
managed by the Division of Biostatistics at Washington University. All web-based information transmission is 
encrypted. The data is all stored on a private, firewall protected network. All users are given individual user 
identification and passwords and their access is restricted on a role-specific basis. REDCap was developed 
specifically around HIPAA-Security guidelines and is implemented and maintained according to Washington 
University guidelines. All paper forms collected in the field with or without personal identifiers will be 
transported via locked brief cases.   
      
SAS software package will be used for data analysis. Datasets generated from these programs will be 
password protected, which will make accessing study data difficult even in the event of unauthorized computer 
access occurs. Systems connected to the Ethernet are carefully controlled, and all systems without Ethernet 
access control are insulated from the backbone by bridges or routers. The Ethernet cable itself is routed only 
through secure passageways. 
 
Adverse Event Reporting and Safety Monitoring 
Because risk in the proposed study is considered minimal, the DSMB will meet semi-annually to review overall 
study progress, safety, and efficacy. However, if more frequent monitoring is required, it will be implemented 
accordingly. At the meetings, Dr. Stark will review progress of the data collection process, evaluate any 
unanticipated or anticipated effects of study participation, and monitor the integrity and the accuracy of the data 
generated from the study. Dr. Stark will present progress in the study and interim analyses at each meeting. 

 
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Minutes of each meeting will be reported to the HRPO.  Dr. Stark will be responsible for executing 
recommendations made by the committee.  
 
All serious adverse events will be reported to the HRPO in the following time frames: a) death, immediately; b) 
life-threatening, within seven calendar days; and c) all other SAEs, within 15 calendar days using the 
Electronic Serious Adverse Event Reporting System. Should there be a serious adverse event that occurs that 
increases the risks to the participants, the study will be stopped, an investigation will be conducted, and a 
findings report will be generated before the study is resumed. 
 
Indemnity 
Washington University School of Medicine is responsible for any non-negligent damage incurred as a result of 
participating in the trial. The indemnity is renewed on an annual basis. Washington University School of 
Medicine assures that it will continue renewal of the indemnity for the duration of the trial.  
 
Ethics and Dissemination 
This protocol and the template informed consent forms will be reviewed and approved by the Washington 
University institutional review board with respect to scientific content and compliance with applicable research 
and human subjects regulations. All study personnel involved in the conduct of this research will receive the 
required education on the protection of human research participant rights. Study projects will not begin until the 
IRB has reviewed and approved all study materials. The protocol will be updated as needed and submitted to 
the IRB for review.  
 
On publication of the study results, participants will be invited to attend a community meeting during which the 
results of the study will be reported. The information will be repeated during three community sessions to be 
held during daylight hours. Participants will receive a mailing announcing the meetings and summarizing the 
study findings. The location of the meetings will be in a fully accessible auditorium with accessible parking and 
access to public transportation. A written report will be distributed, and the results will be presented by the 
study investigators, followed by a question-and-answer period. Refreshments will be served, and participants 
and their family members will be thanked for their generous support of the project. 
 
Authorship Eligibility and Contributorship 
Authorship for this study will be given to key personnel involved in study design, recruitment, data collection, 
and data analysis. There are no publication restrictions and no professional writers will be involved in the 
generation of the manuscript. S. Stark is responsible for conceptualizing study design. 
 
Funding 
Funding for the trial was through The National Institute on Disability, Independent Living, and Rehabilitation 
Research. 
 
Competing Interests 
None of the authors has conflicts of interest to disclose.  
 
References 
 
1. 
Health and Retirement Study. University of Michigan: Ann Arbor, MI, 2015. 
2. 
Stark SL. Removing environmental barriers in the homes of older adults with disabilities improves 
occupational performance. Occupation Participation and Health 2004;24(1):32-39. 
3. 
Stark SL, Landsbaum A, Palmer JL, Somerville EK, Morris JC. Client-centered home modifications 
improve daily activity performance of older adults. Canadian Journal of Occupational Therapy 2009;76 
Spec No:235-45. (In eng) 
(http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=
19757729). 

 
CONFIDENTIAL: This document is the intellectual property of the CEDAR Midwest  research group.  Acceptance of this document constitutes 
the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
21 
4. 
Gitlin LN, Winter L, Dennis MP, Corcoran M, Schinfeld S, Hauck WW. A randomized trial of a 
multicomponent home intervention to reduce functional difficulties in older adults. J Am Geriatr Soc 
2006;54(5):809-16. (In eng). DOI: 10.1111/j.1532-5415.2006.00703.x. 
5. 
Nikolaus T, Bach M. Preventing falls in community-dwelling frail older people using a home 
intervention team (HIT): Results from the randomized Falls: HIT trial. Journal of the American 
Geriatrics Society 2003;51(3):300-305. 
6. 
Wilson DJ, Mitchell JM, Kemp BJ, Adkins RH, Mann W. Effects of assistive technology on functional 
decline in people aging with a disability. Assist Technol 2009;21(4):208-17. (In eng). DOI: 
10.1080/10400430903246068. 
7. 
Linnan L, Steckler A. Process evaluation for public health interventions and research: Jossey-Bass San 
Francisco, California, 2002. 
8. 
Aging Ao. Aging Statistics. (https://aoa.acl.gov/Aging_Statistics/Index.aspx). 
9. 
LaPlante MP. Key goals and indicators for successful aging of adults with early-onset disability. 
Disability and health journal 2014;7(1):S44-S50. 
10. 
Houtenville AJ, Ruiz T. Annual compendium of disability statistics. University of New Hampshire 
2012. 
11. 
Jette A, Field MJ. The future of disability in America. National Academies Press; 2007. 
12. 
Verbrugge LM, Latham K, Clarke PJ. Aging with Disability for Midlife and Older Adults.  2017. 
13. 
Verbrugge LM, Yang L-s. Aging with disability and disability with aging. Journal of disability policy 
studies 2002;12(4):253-267. 
14. 
LaPlante MP. Key goals and indicators for successful aging of adults with early-onset disability. Disabil 
Health J 2014;7(1 Suppl):S44-50. DOI: 10.1016/j.dhjo.2013.08.005. 
15. 
Simonsick EM, Kasper JD, Phillips CL. Physical disability and social interaction: factors associated 
with low social contact and home confinement in disabled older women (The Women's Health and 
Aging Study). J Gerontol B Psychol Sci Soc Sci 1998;53(4):S209-17. 
(https://www.ncbi.nlm.nih.gov/pubmed/9679522). 
16. 
Torres-Gil F, Putnam M. The growing pains of aging: Disability, aging and baby boomers. Healthy 
aging: Challenges and solutions 1999:261-283. 
17. 
Reinhard SC, Kassner E, Houser A, Mollica R. Raising expectations: A state scorecard on long-term 
services and supports for older adults, people with physical disabilities, and family caregivers. 
Washington, DC: AARP 2011. 
18. 
Martin LG, Freedman VA, Schoeni RF, Andreski PM. Trends in disability and related chronic 
conditions among people ages fifty to sixty-four. Health Affairs 2010;29(4):725-731. 
19. 
Salvador-Carulla L, Putnam M, Bigby C, Heller T. Advancing a research agenda for bridging ageing 
and disability. International journal of integrated care 2012;12(8). 
20. 
Ortman JM, Velkoff VA, Hogan H. An aging nation: the older population in the United States. 
Washington, DC: US Census Bureau 2014:25-1140. 
21. 
U.S. Census Bureau. American Community Survey 1-Year Estimates: Disability Characteristics. 2015. 
22. 
Courtney-Long EA, Carroll DD, Zhang QC, et al. Prevalence of disability and disability type among 
adults—United States, 2013. MMWR Morb Mortal Wkly Rep 2015;64(29):777-83. 
23. 
Washko MM, Campbell M, Tilly J. Accelerating the translation of research into practice in long term 
services and supports: a critical need for federal infrastructure at the nexus of aging and disability. 
Journal of gerontological social work 2012;55(2):112-125. 
24. 
Vos T, Barber RM, Bell B, et al. Global, regional, and national incidence, prevalence, and years lived 
with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic 
analysis for the Global Burden of Disease Study 2013. The Lancet 2015;386(9995):743. 
25. 
Hemming K, Hutton JL, Pharoah PO. Long‐term survival for a cohort of adults with cerebral palsy. 
Developmental Medicine & Child Neurology 2006;48(2):90-95. 
26. 
Strauss D, Brooks J, Rosenbloom L, Shavelle R. Life expectancy in cerebral palsy: an update. 
Developmental Medicine & Child Neurology 2008;50(7):487-493. 

 
CONFIDENTIAL: This document is the intellectual property of the CEDAR Midwest  research group.  Acceptance of this document constitutes 
the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
22 
27. 
Strauss D, Ojdana K, Shavelle R, Rosenbloom L. Decline in function and life expectancy of older 
persons with cerebral palsy. NeuroRehabilitation 2004;19(1):69-78. 
28. 
Finlayson M, Van Denend T, Hudson E. Aging with multiple sclerosis. Journal of Neuroscience Nursing 
2004;36(5):245&hyhen. 
29. 
Samsa GP, Patrick CH, Feussner JR. Long-term survival of veterans with traumatic spinal cord injury. 
Archives of Neurology 1993;50(9):909-914. 
30. 
Whiteneck GG, Charlifue S, Frankel H, et al. Mortality, morbidity, and psychosocial outcomes of 
persons spinal cord injured more than 20 years ago. Spinal Cord 1992;30(9):617-630. 
31. 
Schiller JS, Lucas JW, Ward BW, Peregoy JA. Summary health statistics for US Adults: National health 
interview survey, 2010. Vital and Health Statistics Series 10, Data from The National Health Survey 
2012(252):1-207. 
32. 
Iezzoni LI, McCarthy EP, Davis RB, Siebens H. Mobility difficulties are not only a problem of old age. 
Journal of general internal medicine 2001;16(4):235-243. 
33. 
Kinne S, Patrick DL, Doyle DL. Prevalence of secondary conditions among people with disabilities. 
American Journal of Public Health 2004;94(3):443-445. 
34. 
Jette A, Field MJ. The future of disability in America: National Academies Press, 2007. 
35. 
Molton IR, Terrill AL, Smith AE, et al. Modeling secondary health conditions in adults aging with 
physical disability. Journal of aging and health 2014:0898264313516166. 
36. 
Adkins RH. Research and interpretation perspectives on aging related physical morbidity with spinal 
cord injury and brief review of systems. NeuroRehabilitation 2004;19(1):3-13. 
37. 
Bauman WA, Spungen AM. Disorders of carbohydrate and lipid metabolism in veterans with paraplegia 
or quadriplegia: a model of premature aging. Metabolism 1994;43(6):749-756. 
38. 
McColl MA, Charlifue S, Glass C, Lawson N, Savic G. Aging, gender, and spinal cord injury. Archives 
of physical medicine and rehabilitation 2004;85(3):363-367. 
39. 
Schwartz L, Engel JM, Jensen MP. Pain in persons with cerebral palsy. Archives of physical medicine 
and rehabilitation 1999;80(10):1243-1246. 
40. 
Ullrich PM, Jensen MP, Loeser JD, Cardenas DD, Weaver FM. Pain among veterans with spinal cord 
injury. Journal of rehabilitation research and development 2008;45(6):793. 
41. 
Jensen MP, Kuehn CM, Amtmann D, Cardenas DD. Symptom burden in persons with spinal cord 
injury. Archives of physical medicine and rehabilitation 2007;88(5):638-645. 
42. 
Patti F, Ciancio MR, Reggio E, et al. The impact of outpatient rehabilitation on quality of life in multiple 
sclerosis. Journal of neurology 2002;249(8):1027-1033. 
43. 
Savic G, Short D, Weitzenkamp D, Charlifue S, Gardner B. Hospital readmissions in people with 
chronic spinal cord injury. Spinal Cord 2000;38(6):371. 
44. 
Murphy KP, Molnar GE, Lankasky K. MEDICAL AND FUNCTIONAL STATUS OF ADULTS WTH 
CEREBRAL PALSY. Developmental Medicine & Child Neurology 1995;37(12):1075-1084. 
45. 
Gray DB, Hollingsworth HH, Stark S, Morgan KA. A subjective measure of environmental facilitators 
and barriers to participation for people with mobility limitations. Disability and Rehabilitation 
2008;30(6):434-457. 
46. 
Molton IR, Yorkston KM. Growing Older With a Physical Disability: A Special Application of the 
Successful Aging Paradigm. The Journals of Gerontology Series B: Psychological Sciences and Social 
Sciences 2016:gbw122. 
47. 
Stark S, Hollingsworth H, Morgan K, Gray D. Differential patterns of participation between older and 
younger adults with mobility impairments.  Gerontological Society of America’s 59th Annual Meeting. 
Dallas, TX: The Gerontologist; 2006:130. 
48. 
Gray DB, Hollingsworth HH, Stark SL, Morgan KA. Participation survey/mobility: Psychometric 
properties of a measure of participation for people with mobility impairments and limitations. Archives 
of Physical Medicine and Rehabilitation 2006;87(2):189-197. 
49. 
Olmstead v. L.C. 1999. 

 
CONFIDENTIAL: This document is the intellectual property of the CEDAR Midwest  research group.  Acceptance of this document constitutes 
the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
23 
50. 
Reaves EL, Musumeci M. Medicaid and long-term services and supports: A primer. Washington, DC: 
The Kaiser Family Foundation, May 2015;8. 
51. 
Protection P, Act AC. Patient protection and affordable care act. Public Law 2010;111:48. 
52. 
Rosenbaum S, Rothenberg S, Gunsalus R, Schmucker S. Medicaid’s Future: What Might ACA Repeal 
Mean? Issue brief (Commonwealth Fund) 2017;2:1. 
53. 
Putnam M. Bridging network divides: Building capacity to support aging with disability populations 
through research. Disability and health journal 2014;7(1):S51-S59. 
54. 
Ravesloot CH, Seekins T, Cahill T, Lindgren S, Nary DE, White G. Health promotion for people with 
disabilities: development and evaluation of the Living Well with a Disability program. Health Education 
Research 2007;22(4):522-531. DOI: 10.1093/her/cyl114. 
55. 
Ravesloot C. Living Well with a Disability, a self-management program. MMWR supplements 2016;65. 
56. 
AOA. Disease Prevention and Health Promotion Services (OAA Title IIID). 
(https://aoa.acl.gov/AoA_Programs/HPW/Title_IIID/Index.aspx). 
57. 
Molton I. Prevalence and impact of secondary health conditions in individuals aging with, and aging 
into, disability. Paper presented at the Annual Scientific Meeting of the Gerontological Society of 
America, San Diego, California 2012. 
58. 
Charlifue S, Jha A, Lammertse D. Aging with spinal cord injury. Physical medicine and rehabilitation 
clinics of North America 2010;21(2):383-402. 
59. 
Finlayson ML, Peterson EW. Falls, aging, and disability. Physical medicine and rehabilitation clinics of 
North America 2010;21(2):357-373. 
60. 
Mays GP, Hogg RA. Expanding delivery system research in public health settings: lessons from 
practice-based research networks. Journal of public health management and practice: JPHMP 
2012;18(6):485. 
61. 
Mays G. Leading improvement through inquiry: practice-based research networks in public health. 
Leadership in Public Health 2011;9(1). 
62. 
Israel BA, Schulz AJ, Parker EA, Becker AB. Review of community-based research: assessing 
partnership approaches to improve public health. Annual review of public health 1998;19(1):173-202. 
63. 
Minkler M, Wallerstein N. Community-based Participatory Research for Health. San Francisco, CA: 
Jossey-Bass, 2003. 
64. 
Domenech Rodriguez MM, Baumann AA, Schwartz AL. Cultural adaptation of an evidence based 
intervention: From theory to practice in a Latino/a community context. American journal of community 
psychology 2011;47(1-2):170-186. DOI: 10.1007/s10464-010-9371-4. 
65. 
Burgio LD, Collins IB, Schmid B, Wharton T, McCallum D, DeCoster J. Translating the REACH 
Caregiver Intervention for Use by Area Agency on Aging Personnel: the REACH OUT Program. The 
Gerontologist 2009;49(1):103-116. DOI: 10.1093/geront/gnp012. 
66. 
Domenech-Rodriguez M, Wieling E. Developing culturally appropriate evidence based treatments for 
interventions with ethnic minority populations. Voices of color: First person accounts of ethnic minority 
therapists 2004:313-333. 
67. 
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion 
interventions: The RE-AIM framework. American Journal of Public Health 1999;89(9):1322-1327. 
68. 
Green LW, Glasgow RE. Evaluating the relevance, generalization, and applicability of research issues in 
external validation and translation methodology. Evaluation & the Health Professions 2006;29(1):126-
153. 
69. 
Bernal G, Bonilla J, Bellido C. Ecological validity and cultural sensitivity for outcome research: Issues 
for the cultural adaptation and development of psychosocial treatments with Hispanics. Journal of 
Abnormal Child Psychology 1995;23(1):67-82. 
70. 
Stetler CB, McQueen L, Demakis J, Mittman BS. An organizational framework and strategic 
implementation for system-level change to enhance research-based practice: QUERI Series. 
Implementation Science 2008;3(1):30. 

 
CONFIDENTIAL: This document is the intellectual property of the CEDAR Midwest  research group.  Acceptance of this document constitutes 
the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
24 
71. 
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: 
combining elements of clinical effectiveness and implementation research to enhance public health 
impact. Medical Care 2012;50(3):217-226. 
72. 
March JS, Silva SG, Compton S, Shapiro M, Califf R, Krishnan R. The case for practical clinical trials 
in psychiatry. American Journal of Psychiatry 2005;162(5):836-846. 
73. 
Brownson RC, Jacobs JA, Tabak RG, Hoehner CM, Stamatakis KA. Designing for dissemination among 
public health researchers: Findings from a national survey in the United States. American Journal of 
Public Health 2013;103(9):1693-1699. DOI: 10.2105/ajph.2012.301165. 
74. 
Califf RM, Berglund L, for the Principal Investigators of the National Institutes of Health C, 
Translational Science A. Linking scientific discovery and better health for the nation: The first three 
years of the NIH's Clinical and Translational Science Awards. Academic Medicine 2010;85(3):457-462 
10.1097/ACM.0b013e3181ccb74d. 
(http://journals.lww.com/academicmedicine/Fulltext/2010/03000/Linking_Scientific_Discovery_and_Be
tter_Health_for.19.aspx). 
75. 
Klesges LM, Estabrooks PA, Dzewaltowski DA, Bull SS, Glasgow RE. Beginning with the application 
in mind: Designing and planning health behavior change interventions to enhance dissemination. Annals 
of Behavioral Medicine 2005;29(2):66-75. 
76. 
Sleet DA, Moffett DB, Stevens J. CDC's research portfolio in older adult fall prevention: A review of 
progress, 1985-2005, and future research directions. Journal of Safety Research 2008;39(3):259-267. 
DOI: http://dx.doi.org/10.1016/j.jsr.2008.05.003. 
77. 
Stark S, Somerville E, Keglovits M, et al. Protocol for the home hazards removal program (HARP) 
study: a pragmatic, randomized clinical trial and implementation study. BMC Geriatrics 2017;17(1):90. 
(In eng). DOI: 10.1186/s12877-017-0478-4. 
78. 
Stark S, Somerville E, Keglovits M, et al. Protocol for the home hazards removal program (HARP) 
study: a pragmatic, randomized clinical trial and implementation study. Bmc Geriatr 2017;17 (In 
English). DOI: ARTN 90 
10.1186/s12877-017-0478-4. 
79. 
Stark S, Keglovits M, Somerville E, et al. Home Hazard Removal to Reduce Falls Among Community-
Dwelling Older Adults: A Randomized Clinical Trial. JAMA Network Open 2021;4(8):e2122044-
e2122044. DOI: 10.1001/jamanetworkopen.2021.22044. 
80. 
Agency for Healthcare Research and Quality. Register Your Network. (https://pbrn.ahrq.gov/pbrn-
registry/register-your-network). 
81. 
Alden D, Austin C, Sturgeon R. A correlation between the geriatric depression scale long and short 
forms Journal Of Gerontology 1989;44:124-25. 
82. 
Relton C, Torgerson D, O'Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: 
introducing the "cohort multiple randomised controlled trial" design. BMJ 2010;340. DOI: 
10.1136/bmj.c1066. 
83. 
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture 
(REDCap)a metadata-driven methodology and workflow process for providing translational research 
informatics support. Journal of biomedical informatics 2009;42(2):377-381. 
84. 
North American Care Primary Research Group. PBRN Research Good Practices (PRGP). 
(http://www.napcrg.org/Portals/51/Documents/PBRN%20Conf%20Handouts/PRGP%202014-09-
29.pdf). 
85. 
Dolor RJ, Campbell‐Voytal K, Daly J, et al. Practice‐based Research Network Research Good Practices 
(PRGPs): Summary of Recommendations. Clinical and translational science 2015;8(6):638-646. 
86. 
Agency for Healthcare Research and Quality. Toolkits. 
(http://www.ahrq.gov/professionals/education/ahrq-toolkits.html). 
87. 
French S, Godwin M, Gotlib A, Graham ID, Leboeuf-Yde C. Creating a chiropractic practice-based 
research network (PBRN): enhancing the management of musculoskeletal care. CANADIAN 
CHIROPRACTIC ASSOCIATION 2014:8. 

 
CONFIDENTIAL: This document is the intellectual property of the CEDAR Midwest  research group.  Acceptance of this document constitutes 
the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
25 
88. 
Minasian LM, Carpenter WR, Weiner BJ, et al. Translating research into evidence‐based practice. 
Cancer 2010;116(19):4440-4449. 
89. 
Ribisl KM, Walton MA, Mowbray CT, Luke DA, Davidson WS, Bootsmiller BJ. Minimizing 
participant attrition in panel studies through the use of effective retention and tracking strategies: 
Review and recommendations. Evaluation and Program Planning 1996;19(1):1-25. 
90. 
Klein SI, Rosage L, Shaw G. The role of occupational therapists in home modification programs at an 
area agency on aging. Physical & Occupational Therapy in Geriatrics 2000;16(3-4):19-37. 
91. 
Tomita MR, Moffat M, Usiak DJ, Moffat J. Profile of centers for independent living based on the 
National CIL Management Database. Journal of Vocational Rehabilitation 2004;20(1):21-34. 
92. 
Bowen RE. The use of occupational therapists in independent living programs. American Journal of 
Occupational Therapy 1994;48(2):105-112. 
93. 
Clemson L, Fitzgerald MH, Heard R. Content validity of an assessment tool to identify home fall 
hazards: The Westmead Home Safety Assessment. British Journal of Occupational Therapy 
1999;62(4):171-179. 
94. 
Lawton M, Namehow L. Ecology and the aging process. In: Eisdorfer CL, Lawton MP, eds. Psychology 
of Adult Development and Aging. Washington DC: American Psychological Association; 1973:619-
674. 
95. 
Whyte J, Hart T. It's more than a black box; It's a Russian doll: Defining rehabilitation treatments. 
American Journal of Physical Medicine & Rehabilitation 2003;82(8):639-652. 
(http://journals.lww.com/ajpmr/Fulltext/2003/08000/It_s_More_Than_a_Black_Box__It_s_a_Russian_
Doll_.12.aspx). 
96. 
Dobkin BH. Strategies for stroke rehabilitation. The Lancet Neurology 2004;3(9):528-536. DOI: 
http://dx.doi.org/10.1016/S1474-4422(04)00851-8. 
97. 
Wagner SL, Davis EHC, Gouthous L, Wallace J, LoGerfo M, Kent D. Preventing disability and 
managing chronic illness in frail older adults: A randomized trial of a community-based partnership with 
primary care. J Am Ger Soc 1998;46:1191-8. 
98. 
Schulz R, Burgio L, Burns R, et al. Resources for enhancing Alzheimer's caregiver health (REACH): 
Overview, site-specific outcomes, and future directions. The Gerontologist 2003;43(4):514-520. 
99. 
Kreuter MW, Skinner CS. Tailoring: What's in a name? Health Educ Res 2000;15(1):1-4. DOI: 
10.1093/her/15.1.1. 
100. 
Stark S, Keglovits, M., Lieberman, D., and Arbesman, M. Effectiveness of home modification 
interventions on participation for community-dwelling adults and older adults: A systematic review. 
American Journal of Occupational Therapy (in press). 
101. 
Hammel J, Magasi S, Heinemann A, et al. Environmental barriers and supports to everyday 
participation: A qualitative insider perspective from people with disabilities. Archives of Physical 
Medicine and Rehabilitation 2015;96(4):578-588. 
102. 
Wood-Dauphinee S, Williams JI. Reintegration to normal living as a proxy to quality of life. Journal of 
Chronic Diseases 1987;40(6):491-499. 
103. 
Wood-Dauphinee SL, Opzoomer MA, Williams JI, Marchand B, Spitzer WO. Assessment of global 
function: The Reintegration to Normal Living Index. Archives of Physical Medicine and Rehabilitation 
1988;69(8):583-590. 
104. 
Clarke PJ. Handicap in stroke survivors. Disability and Rehabilitation 1999;21(3):116-123. DOI: 
doi:10.1080/096382899297855. 
105. 
Daneski K, Coshall C, Tillingand K, Wolfe CDA. Reliability and validity of a postal version of the 
Reintegration to Normal Living Index, modified for use with stroke patients. Clinical Rehabilitation 
2003;17(8):835-839. 
106. 
Stark SL, Somerville EK, Morris JC. In-Home Occupational Performance Evaluation (I-HOPE). The 
American Journal of Occupational Therapy 2010;64(4):580-589. 
107. 
Krueger RA, Casey MA. Focus groups : A practical guide for applied research2015. 
108. 
Morgan D. The Focus Group Kit. Thousand Oaks, CA: Sage, 1998. 

 
CONFIDENTIAL: This document is the intellectual property of the CEDAR Midwest  research group.  Acceptance of this document constitutes 
the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
26 
109. 
Bertrand JT, Brown JE, Ward VM. Techniques for analyzing focus group data. Evaluation review 
1992;16(2):198-209. 
110. 
Rabiee F. Focus-group interview and data analysis. Proceedings of the Nutrition Society 
2004;63(04):655-660. 
111. 
Strauss AL, Corbin J. Basics of Qualitative Research : Techniques and Procedures for Developing 
Grounded Theory. 2nd ed. Thousand Oaks, California: Sage, 1998. 
112. 
Onwuegbuzie AJ, Dickinson WB, Leech NL, Zoran AG. A qualitative framework for collecting and 
analyzing data in focus group research. International Journal of Qualitative Methods 2009;8(3):1-21. 
113. 
Leech NL, Onwuegbuzie AJ. An array of qualitative data analysis tools: A call for data analysis 
triangulation. School Psychology Quarterly 2007;22(4):557. 
114. 
Creswell JW, Miller DL. Determining validity in qualitative inquiry. Theory into Practice 
2000;39(3):124-130. 
115. 
Lincoln YS, Guba EG. Naturalistic inquiry. Newbury Park, CA: Sage, 1985. 
116. 
Clement S, Pickering A, Rowlands G, Thiru K, Candy B, de Lusignan S. Towards a conceptual 
framework for evaluating primary care research networks. The British Journal of General Practice 
2000;50(457):651-652. (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1313777/). 
117. 
Fenton E, Harvey J, Sturt J. Evaluating primary care research networks. Health Services Management 
Research 2007;20(3):162-173. 
118. 
Bayliss EA, Ellis JL, Shoup JA, Zeng C, McQuillan DB, Steiner JF. Association of patient-centered 
outcomes with patient-reported and ICD-9–based morbidity measures. The Annals of Family Medicine 
2012;10(2):126-133. 
119. 
Bayliss EA, Ellis JL, Steiner JF. Barriers to self-management and quality-of-life outcomes in seniors 
with multimorbidities. The Annals of Family Medicine 2007;5(5):395-402. 
120. 
Bayliss EA, Ellis JL, Steiner JF. Seniors’ self-reported multimorbidity captured biopsychosocial factors 
not incorporated into two other data-based morbidity measures. Journal of clinical epidemiology 
2009;62(5):550-557. e1. 
121. 
Bureau USC. How Disability Data are Collected from The American Community Survey. 
122. 
Galvin JE, Zweig Y. The AD-8: The Washington University Dementia Screening Test. Family Medicine 
2013;25(3):367-382. 
123. 
Cook KF, Bamer AM, Amtmann D, Molton IR, Jensen MP. Six patient-reported outcome measurement 
information system short form measures have negligible age-or diagnosis-related differential item 
functioning in individuals with disabilities. Arch Phys Med Rehabil 2012;93:1289-1291. DOI: 
10.1016/j.apmr.2011.11.022. 
124. 
Noonan VK, Cook KF, Bamer AM, Choi SW, Kim J, Amtmann D. Measuring fatigue in persons with 
multiple sclerosis: Creating a crosswalk between the Modified Fatigue Impact Scale and the PROMIS 
Fatigue Short Form. Quality of Life Research 2012;21(7):1123-1133. DOI: 10.1007/s11136-011-0040-3  
125. 
Cella D, Riley W, Stone A, et al. The Patient -Reported Outcomes Measurement Information System 
(PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-
2008. J Clin Epidemiol 2010;63(11):1179-1194. DOI: 10.1016/j.jclinepi.2010.04.011. 
126. 
Revicki DA, Chen W-H, Harnam N, et al. Development and psychometric analysis of the PROMIS pain 
behavior item bank. Pain 2009;146(1-2):158-169. 
127. 
Chen W-H, Revicki D, Amtmann D, Jensen MP, Keefe FJ, Cella D. Development and Analysis of 
PROMIS Pain Intensity Scale. Quality of Life Research 2012;20:18. 
128. 
Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS® measures of self-
efficacy for managing chronic conditions. Quality of Life Research 2017;26(7):1915-1924. 
129. 
Campbell‐Sills L, Stein MB. Psychometric analysis and refinement of the connor–davidson resilience 
scale (CD‐RISC): Validation of a 10‐item measure of resilience. Journal of traumatic stress 
2007;20(6):1019-1028. 
130. 
Reeve BBH, R. D., Bjorner JB, Cook KF, et al. Psychometric evaluation and calibration of health-
related quality of life item Medical Care 2007;45(5 Suppl 1):S22-S31. 

 
CONFIDENTIAL: This document is the intellectual property of the CEDAR Midwest  research group.  Acceptance of this document constitutes 
the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
27 
131. 
Amtmann DA, Cook KF, Jensen MP, et al. Development of a PROMIS item bank to measure pain 
interference. Pain 2010;150(1):173-182. 
132. 
Hahn EA, DeVellis RF, Bode RK, et al. Measuring social health in the patient-reported outcomes 
measurement information system (PROMIS): item bank development and testing. Quality of Life 
Research 2010;19(7):1035-1044. 
133. 
Hahn EA, Beaumont JL, Pilkonis PA, et al. The PROMIS satisfaction with social participation measures 
demonstrated responsiveness in diverse clinical populations. Journal of clinical epidemiology 
2016;73:135-141. 
134. 
Whiteneck GG, Gerhart KA, Cusick CP. Identifying environmental factors that influence the outcomes 
of people with traumatic brain injury. J Head Trauma Rehabil 2004;19(3):191-204. 
135. 
Law M, Petrenchik T, King G, Hurley P. Perceived environmental barriers to recreational, community, 
and school participation for children and youth with physical disabilities. Arch Phys Med Rehabil 
2007;88(12):1636-1642. 
136. 
Hahn EA, DeWalt DA, Bode RK, et al. New English and Spanish social health measures will facilitate 
evaluating health determinants. Health Psychology 2014;33(5):490. 
137. 
Organization WH. Survey tool and guidance: rapid, simple, flexible behavioural insights on COVID-19: 
29 July 2020. 2020. 
138. 
University JH. COVID-19 COMMUNITY RESPONSE SURVEY GUIDANCE. April 6 2020 
(https://www.nlm.nih.gov/dr2/JHU_COVID-19_Community_Response_Survey_v1.3.pdf). 
139. 
Harris P. Appendix G8: COvid-19 Participant Experience (COPE) Survey. April 15 2020 
(https://www.nlm.nih.gov/dr2/COPE_Survey_NIH_All_of_Us_Clean_4.27.20.pdf). 
140. 
Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health 
summary scores from the patient-reported outcomes measurement information system (PROMIS) global 
items. Quality of Life Research 2009;18(7):873-880. 
141. 
Stark S, Somerville E, Morris J. In-Home Occupational Performance Evaluation. American Journal of 
Occupational Therapy in press. 
142. 
Wood-Dauphinee S, Opzoomer M, Williams J, Marchand B, Spitzer W. Assessment of global function: 
The Reintegration to Normal Living Index. Archives of physical medicine and rehabilitation 
1988;69(8):583-590. 
143. 
Finlayson ML, Peterson EW, Fujimoto KA, Plow MA. Rasch validation of the falls prevention strategies 
survey. Archives of physical medicine and rehabilitation 2009;90(12):2039-2046. 
144. 
Yorkston KM, Kuehn CM, Johnson KL, Ehde DM, Jensen MP, Amtmann D. Measuring participation in 
people living with multiple sclerosis: A comparison of self-reported frequency, importance and self-
efficacy. Disability and Rehabilitation 2008;30(2):88-97. DOI: 10.1080/09638280701191891. 
145. 
Weersing VR, Rozenman M, Gonzalez A. Core components of therapy in youth: Do we know what to 
disseminate? Behavior Modification 2009;33(1):24-47. 
146. 
Hildebrand MW, Host HH, Binder EF, et al. Measuring treatment fidelity in a rehabilitation intervention 
study. American journal of physical medicine & rehabilitation/Association of Academic Physiatrists 
2012;91(8):715. 
147. 
Cumming RG, Thomas M, Szonyi G, Frampton G, Salkeld G, Clemson L. Adherence to occupational 
therapist recommendations for home modifications for fall prevention. American Journal of 
Occupational Therapy 2001;55(6):641-648. 
148. 
Tinetti ME, Speechley M, Ginter SF. Risk Factors for Falsl among Elderly PErsons Living in the 
Community. New England Journal of Medicine 1988;319(26):1701-1701. 
149. 
Kroenke K, Wu J, Yu Z, et al. Patient Health Questionnaire Anxiety and Depression Scale: Initial 
Validation in Three Clinical Trials. Psychosom Med 2016;78(6):716-727. (In eng). DOI: 
10.1097/PSY.0000000000000322. 
150. 
Fillenbaum G. Multidimensional Functional Assessment of Older Adults. New York: Psychology Press; 
1988. 

 
CONFIDENTIAL: This document is the intellectual property of the CEDAR Midwest  research group.  Acceptance of this document constitutes 
the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
28 
151. 
Fillenbaum GG, Smyer MA. The Development, Validity, and Reliability of the Oars Multidimensional 
Functional Assessment Questionnaire1. Journal of Gerontology 1981;36(4):428-434. DOI: 
10.1093/geronj/36.4.428. 
152. 
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly 
persons. Journal of the American Geriatrics Society 1991;39(2):142-8. (In eng). DOI: 10.1111/j.1532-
5415.1991.tb01616.x. 
153. 
Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of 
the Falls Efficacy Scale-International (FES-I). Age and Ageing 2005;34(6):614-619. DOI: 
10.1093/ageing/afi196. 
154. 
Kempen GIJM, Yardley L, Van Haastregt JCM, et al. The Short FES-I: a shortened version of the falls 
efficacy scale-international to assess fear of falling. Age and Ageing 2007;37(1):45-50. DOI: 
10.1093/ageing/afm157. 
155. 
Clemson L, Cumming RG, Heard R. The Development of an Assessment To Evaluate Behavioral 
Factors Associated With Falling. The American Journal of Occupational Therapy 2003;57(4):380-388. 
DOI: 10.5014/ajot.57.4.380. 
156. 
Clemson L, Bundy AC, Cumming RG, Kay L, Luckett T. Validating the Falls Behavioural (FaB) scale 
for older people: a Rasch analysis. Disability and Rehabilitation 2008;30(7):498-06. (In eng). DOI: 
10.1080/09638280701355546. 
157. 
Clemson L, Roland M, Cumming RG. Types of hazards in the homes of elderly people. The 
Occupational Therapy Journal of Research 1997;17(3):200-213. 
158. 
Ferris FL, 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. 
American journal of ophthalmology 1982;94(1):91-6. (In eng). 
159. 
Beck RW, Moke PS, Turpin AH, et al. A computerized method of visual acuity testing: adaptation of the 
early treatment of diabetic retinopathy study testing protocol. American journal of ophthalmology 
2003;135(2):194-205. (In eng). DOI: 10.1016/s0002-9394(02)01825-1. 
160. 
Skinner HA. The drug abuse screening test. Addictive behaviors 1982;7(4):363-71. (In eng). DOI: 
10.1016/0306-4603(82)90005-3. 
161. 
Blow F. Michigan Alcoholism Screening Test- Geriatric Version (MAST-G). Ann Arbor, MI: 
University of MIchigan alcohol Research Center; 1991. 
162. 
Goodman RM, Wandersman A, Chinman M, Imm P, Morrissey E. An ecological assessment of 
community-based interventions for prevention and health promotion: Approaches to measuring 
community coalitions. American journal of community psychology 1996;24(1):33-61. 
163. 
Cumming RG, Thomas M, Szonyi G, Frampton G, Salkeld G, Clemson L. Adherence to occupational 
therapist recommendations for home modifications for falls prevention. The American Journal of 
Occupational Therapy 2001;55(6):641-648. 
164. 
U.S. Department of Labor: Bureau of Labor Statistics. National Compensation Survey: Summary. 
(http://www.bls.gov/ncs/summary.htm#ocs.). 
165. 
Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-Effectiveness in Health and Medicine. 1 ed. New 
York: Oxford University Press, 1996. 
166. 
Cook KF, Bamer AM, Amtmann D, Molton IR, Jensen MP. Six patient-reported outcome measurement 
information system short form measures have negligible age-or diagnosis-related differential item 
functioning in individuals with disabilities. Arch Phys Med Rehabil 2012;93(7):1289-1291. 
167. 
Amtmann D, Bamer AM, Kim J, Chung H, Salem R. People with multiple sclerosis report significantly 
worse symptoms and health related quality of life than the US general population as measured by 
PROMIS and NeuroQoL outcome measures. Disability and health journal 2018;11(1):99-107. 
168. 
Molton I, Cook KF, Smith AE, Amtmann D, Chen W-H, Jensen MP. Prevalence and impact of pain in 
adults aging with a physical disability: Comparison to a US general population sample. The Clinical 
journal of pain 2014;30(4):307-315. 

 
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the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior written approval. 
29 
169. 
Jensen MP, Smith AE, Bombardier CH, Yorkston KM, Miró J, Molton IR. Social support, depression, 
and physical disability: age and diagnostic group effects. Disability and health journal 2014;7(2):164-
172. 
170. 
Oakley A, Strange V, Bonell C, Allen E, Stephenson J. Health services research: process evaluation in 
randomised controlled trials of complex interventions. BMJ: British Medical Journal 
2006;332(7538):413. 
171. 
Plow MA, Finlayson M, Gunzler D, Heinemann AW. Correlates of participation in meaningful activities 
among people with multiple sclerosis. Journal of Rehabilitation Medicine 2015;47(6):538-545. 
172. 
Crawford A, Hollingsworth HH, Morgan K, Gray DB. People with mobility impairments: Physical 
activity and quality of participation. Disability and Health Journal 2008;1(1):7-13. 
173. 
Faul F, Erdfelder E, Lang A-G, Buchner A. G* Power 3: A flexible statistical power analysis program 
for the social, behavioral, and biomedical sciences. Behavior research methods 2007;39(2):175-191.