Daily Engagement in Meaningful Activities Professional (DEMA-Pro) Intervention for Seniors With Subjective Cognitive Decline and Living at Home
Phase: NA
Conditions: Subjective Cognitive Decline
Sponsor: Indiana University

IRB#: 2008540965 
 
Daily Engagement in Meaningful Activities Professional (DEMA-Pro) intervention for 
seniors with subjective cognitive decline and living at home 
 
Principal Investigator: Yvonne Lu, PhD, RN, FGSA, FAAN 
Professor, Department of Science Nursing Care 
Indiana University School of Nursing 
600 Barnhill Drive, NU W407 
Indianapolis, IN 46202 
 
 
Co-Investigators 
Susan E. Hickman, PhD, 
Professor, Department of Science Nursing Care 
Indiana University of School of Nursing 
 
Joan E. Haase, PhD, RN, FAAN 
Professor, Department of Science Nursing Care 
Indiana University of School of Nursing 
 
Susan M. Perkins, PhD 
Professor, Biostatistics of Department 
Indiana University School of Medicine 
 
Pei-Shiun Chang, PhD, RN, MSN, ACNP-BC 
Assistant Professor, Department of Community Health System 
Indiana University School of Nursing 
 
Jennifer Ellis, DPT, PhD, GCS 
Vice President of Research and Business Development, Gentiva Health Services, 
Inc., d/b/a Kindred at Home. 
 
 
Support Provided by: 
NIH, NIA, Protocol Number: AG0700265 
 
 
NCT#: 04796415 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version Date: 2023 09 12 
Page 1 of 1 

A. 
SPECIFIC AIMS 
Over 4.4 million Americans receive home health services after hospital or rehabilitation facility 
discharge to improve function, foster independence, promote health-related quality of life and 
sense of well-being (QoL), and decrease unnecessary hospital or nursing home stays. Among 
these patients, > 80% are 65 years or older, most manage at least two chronic conditions, and 
nearly 70% report subjective cognitive decline (SCD).1-1 SCD is an early clinical sign of 
Alzheimer’s disease and related dementia (ADRD).2-4 SCD is associated with diminished activity 
performance,5-7 poor QoL,8,9 and other adverse health outcomes (e.g., depressive 
symptoms).8,10 
Home health patients with SCD require more time, structure, and guidance to complete tasks 
and adjust to new skills and environments. Without support, they often lose their sense of 
control, have fewer personal choices,11 and disengage from meaningful activities.12,13 Meaningful 
activities are self-identified activities based on the individual’s previous life experiences, sense 
of intentionality, and goals to remain involved in desired activities and personal relationships.14,15 
In older adults, engagement in meaningful activities is associated with better physical and 
mental health, QoL, reduced risk of cognitive decline and mortality.14,16,17 Poor engagement in 
meaningful activities results in rapid patient decline18 that may otherwise be preventable. For 
those with SCD who are at risk of declining and progressing to preclinical ADRD,19 new care 
delivery models that promote engagement in meaningful activities to enhance patient outcomes 
are needed. Because informal caregivers are usually unprepared, lack confidence in their new 
caregiver role, and have difficulty providing support,1,20 it is vitally important to include these 
caregivers in new care delivery models. 
We propose a new home health care delivery model in partnership with Kindred at Home (KAH) 
Gentiva Health Services, a division of Humana that encompasses 400 sites across 40 states. 
Our proposed telephone-delivered care model, Daily Engagement in Meaningful Activities- 
Professional (DEMA-Pro) is a Positive Health intervention21 that is strengths-based, family- 
centered, and tailored to patient/caregiver goals and values. DEMA-Pro addresses the core 
problem of diminished engagement in meaningful activities among SCD patients at home by: 1) 
coaching patient-caregiver dyads to problem-solve; 2) teaching the dyads self-management and 
communication skills; and 3) enhancing naturally occurring patient-caregiver interactions 
necessary to accomplish self-identified, mutually agreed upon goals. DEMA-Pro builds on five 
preliminary studies of the DEMA intervention22-28 that demonstrated high feasibility, acceptability, 
and positive preliminary effects on health outcomes (physical function, mood, and QoL).27,28 
DEMA-Pro will be refined for delivery by home health services staff to patients with SCD and 
their informal caregivers. 
The purpose of this R61/R33 grant proposal is to conduct a pragmatic cluster randomized 
controlled trial (RCT) of DEMA-Pro to improve outcomes in home health service patients with 
SCD. In the R61 phase, we will establish the organizational structure and processes and pilot 
test DEMA-Pro in 4 KAH home health service facilities. In the R33 phase we will conduct a full 
pragmatic RCT in 40 KAH facilities to compare DEMA-Pro to usual care. In accordance with 
pragmatic trial principles, we will primarily use existing data sources including electronic 
Medicare OASIS (Outcome and Assessment Information Set) data to characterize the cohort 
and measure outcomes. R61 and R33 Specific aims are: 
R61 Phase (12 months)  
Aim 1. Establish the organizational infrastructure and programmatic processes needed to 
conduct a pragmatic cluster-randomized control trial of the DEMA-Pro intervention versus usual 
care. A Steering Committee will lead the project and coordinate the activities of 3 Work Groups: 
Regulatory and Operations; DEMA-Pro Intervention Protocol; and Data Management and 
Analysis. 
Aim 2. Pilot test the DEMA-Pro training protocol in 4 KAH North Region locations and refine as 
indicated. 

39,40,46 
8,9,41-43 
R33 Phase (48 months). 
Forty KAH home health services sites will be randomized to DEMA-Pro or usual care. DEMA- 
Pro site home health services staff will be trained as DEMA-Pro coaches who will work with 
home health service leaders to: (1) consolidate home health services DEMA-Pro procedures; 
(2) train and educate staff; and (3) facilitate DEMA-Pro coaching with patients and their family 
caregivers. The implementation period will be 18 months and all enrolled patients will be 
followed for 12 months. 
Aim 3. Compare outcomes of DEMA-Pro to Usual Care over 12 months. 
Hypotheses (H). Compared to usual care, DEMA-Pro patients will have: H 3.1(primary) higher 
physical function; H 3.2 higher overall quality of life (i.e. Sense of well-being) (QoL); H 3.3 lower 
depression, and, H 3.4. lower rates of transfers to nursing home per 1000 person days. 
Impact: By valuing and fostering a positive health model of care, an efficacious DEMA-Pro has 
potential to facilitate a paradigm shift in how elderly patients in the USA are cared for at home. 
B. SIGNIFICANCE: R61/R33 
 
Cognitive decline is a significant burden for patients, family caregivers, healthcare 
providers, and society. Subjective cognitive decline (SCD) affects significant numbers of older 
adults.1 Patients with SCD report reduced cognitive ability to function at expected levels,29- 
31 disengagement from meaningful activities,25,32 and diminished confidence in ability to manage 
daily challenges25,33,34 and other chronic illness issues.35-38 Patients with SCD also experience poor 
communication that contributes to decreased dyadic agreement regarding patient functional 
ability,33,39,40 poor quality of life (QoL), 
patient/caregiver relationship satisfaction. 
anxiety, depressive symptoms,44,45 and poor 
Family caregivers (family or friends; henceforth 
referred to as “caregivers”) often feel unprepared and lack confidence to deal with their new 
caregiving duties and daily challenges.23,46-49 With our aging population, our society faces 
increased numbers of people with SCD, high, complex demands on home health services,50,51 
and increased burden for millions of older persons, their families, healthcare providers, and the 
health care system.51-54 
 
SCD provides a critical window of time to provide early interventions to slow the onset of 
dementia and improve negative outcomes. SCD patients and their caregivers need early, 
supportive interventions from home health services staff to slow functional decline and improve 
health outcomes. While there are no proven cures or treatments for Alzheimer’s disease and 
related dementia (ADRD), there is strong evidence that combining four or five healthy lifestyle 
behaviors (i.e., heathy diet, regular exercise, cognitive stimulation, non-smoking, social activity) 
decreases risk of AD, compared to having none or only one of the five behaviors.55,56 However, 
two of these behaviors, cognitive stimulation and exercise, are less likely to be meaningful 
enough be sustained by older persons’ over time or foster engagement in additional activities.55- 
58 Very few interventions focus on SCD patients and their caregiver in home health services 
settings.55,59 The Institute of Medicine recommended research on active engagement of both 
patients and their caregivers as a fundamental feature of successful interventions,60 but few 
dyadic interventions are developed, tested, or evaluated in the home health setting.12 Tailored 
positive health interventions for SCD patients living at home are sorely needed,61 and 
opportunities to intervene before progression to moderate/advanced dementia are few. 
 
Patient-driven care and meaningful activity engagement are critical components of home 
health services. Sustained engagement in meaningful activities is essential for patient 
QoL.15,62 Home health services should optimize the abilities of patients with SCD and QoL, 
through engagement in meaningful activity.63 Unfortunately, healthcare teams often lack 
important information regarding patient goals, values, and preferences necessary to develop 
appropriate plans of care. Also, very few supportive care interventions focus on SCD patient- 

informal caregiver dyads and none promote reengagement in preferred meaningful activities to 
maximize QoL, preserve activity performance, prolong independence, and delay 
institutionalization. Current SCD interventions are rarely tailored to patient preferences, do not 
involve caregivers,55,58 and are not easily integrated into the well-established, daily routines. 
Dyadic engagement in self-selected meaningful activities may be an efficient means to: 1) 
improve patient and caregiver confidence to manage patient’s daily challenges,15,64 2) promote 
long-term engagement in meaningful activities;14,18,65 3) foster feelings of pleasure, 
connectedness, identity,14,64 autonomy, and goal directedness;14,26-28 and, 4) enhance patient 
activity performance over time14,15—all of which are important to maintain patient abilities. Mutual 
engagement in daily meaningful activities can enhance the patient-caregiver 
relationships ,15,66 and enhance both patient and caregiver QoL.25 
 
The Daily Engagement in Meaningful Activities (DEMA) intervention is a practical, 
promising solution to improve QoL for home health service patients with SCD and 
reduce caregiver burden. To ensure effective health promotion and quality engagement, 
DEMA fosters full patient engagement, with caregiver support, to identify meaningful activities, 
assess capacity, problem-solve barriers, and establish routines for engagement. Our previous 
studies found prevention of patient disengagement requires a structured, goal-setting approach 
to foster continued or renewed engagement in diverse meaningful activities.26-28 DEMA’s highly 
person-centered approach to activity engagement begins with the patient identifying valued 
activities and addressing the individual's unique barriers to engagement. Meaningful activity 
engagement promotes patient and caregiver life satisfaction by coaching the dyad on problem- 
solving, self-management, active listening, and communication skills, and by enhancing 
naturally occurring patient/caregiver interactions to accomplish self-identified and mutually 
agreed upon goals.26,27,49 
 
Regardless of whether patients progress to ADRD, remain stable, or improve,67 patients 
and caregivers can benefit from DEMA-Pro. This R61 will lead to an R33 pragmatic trial by: 
1) creating the organizational structure in the R61 (pilot) phase to be used in the R33 phase; 2) 
recruiting participants across 4 home health service locations; 3) adapting the DEMA training 
protocol in collaboration with the KAH professional team to create DEMA-Pro; and, 4) using 
blended learning modules (i.e. electronic and in-person delivery). 
 
IMPACT. SCD is a risk factor for developing Alzheimer disease (AD).68 Over five million 
Americans had dementia in 2019, with projections of 7.1 million by 2025.51 Innovative 
interventions to address the growing demands for high quality care in this population, and foster 
both health-related quality of life, quality of life as overall sense of well-being are needed. The 
interprofessional, telephone delivered DEMA-Pro program, aimed to improve quality of care and 
patient health outcomes, offers an efficient, cost-efficient care model. 
 
C. INNOVATION: R61/R33 
 
DEMA is the first telephone-delivered intervention for patients with SCD and caregivers 
with demonstrated high feasibility, acceptability, and positive preliminary effects on 
health outcomes (physical function, mood, and QoL).27,28 DEMA is primarily telephone 
delivered (1 in-person and 5 telephone session) and 5 preliminary studies demonstrated very 
high feasibility: 98% participant consent and 94% completion,27 indicating unusually high patient 
and caregiver acceptance, minimal burden, and intervention value, compared to other studies of 
older adults with cognitive impairment (completion rates 60 to 78%).69-72 DEMA participants 
reported high satisfaction with the intervener information provided over time. Group 
comparisons, DEMA mean scores were significantly higher for overall satisfaction subscale: 

usefulness (p=.025) and ease of use (p=.038).28 Participant’s post intervention interviews 
support the helpfulness of DEMA (e.g., Patient: “(DEMA) let me know I’m not the only 
one…There are things that you can do…to resolve or make them not as big of a problem … the 
daily logs showed I was doing much more than I believed.” Caregiver: “A program like this is 
extremely important. If nobody pays any attention…there’s no improvement, there’s nothing. 
Most helpful [was] understanding the challenges of memory impairment, learning and practicing 
a variety of coping skills, and realizing I need to reach out for help without guilt feeling”.28 
 
The DEMA-Pro intervention will be the first to address the engagement constraints of 
older persons with SCD using a Positive Health approach to foster sustainable 
engagement in meaningful activities that are based on the shared values and priorities of 
both patients’ and caregivers’. There is emerging evidence that regular, personalized, and 
self-identified engagement in any meaningful activities can improve quality of life, depressive 
symptoms, anxiety, and dyad communication.14,15,65,73,74 The DEMA-Pro Program is: 1) tailored to 
patients’ activity priorities and functional abilities; 2) flexible in activity selection (e.g. one long- 
term or several short-term activities); 3) collaborative between the patient and caregiver in 
developing and executing the personalized meaningful activity plan; and; 4) relevant and 
tailored to patient/caregiver’s priority needs for written information related to the 6 priority topics 
identified and evaluated by focus groups.27,28,30,31 
 
DEMA-Pro will be the first large-scale pragmatic RCT to evaluate a telephone intervention 
embedded in existing home health services teams’ care for patients with SCD and their 
family caregivers (Aims 1-3). DEMA-Pro delivery within a pragmatic RCT increases likelihood 
of success and sustainability. Advantages of this pragmatic trial approach include: 1) 
coordinated training; 2) DEMA-Pro delivery by dedicated KAH Call Center coaches in 
collaboration with home health services providers in the field; and, 3) flexible incorporation of 
DEMA-Pro into home health services policies and procedures. For example, KAH home health 
service teams will train the KAH Call Center care coordinators to deliver DEMA-Pro and create 
DEMA-Pro care plans to be implemented by clinical staff in the field with the aim to enhance 
patient and caregiver engagement in self-selected meaningful activities in home settings. The 
field staff will be meeting regularly to support the patients in reaching their goals based on the 
plan created by the coach in the call center. DEMA-Pro will also be integrated into the home 
health services culture and existing administrative structures, which drives change in home 
health services settings. For example, the DEMA-Pro Coach will have accountability to their 
supervisors for their activities as part of their position. Internally generated benchmarking will 
increase willingness to devote time and resources by elevating the profile of this important staff 
function. 
 
DEMA is efficiently delivered in home settings and DEMA-Pro will leverage DEMA’s 
lessons-learned through delivery as a demonstration project in one of the largest home 
health services companies in the USA (Aim 1). The DEMA-Pro Program capitalizes on our 
team’s experiences delivering a highly person-centered approach to activity engagement based 
on patient-identified valued activities and addressing the individual's unique barriers to 
engagement. Meaningful activity engagement fosters better patient physical function and quality 
of life (sense of well-being) by coaching dyad problem-solving, self-management, active 
listening, communication skills, and by enhancing the naturally occurring patient/caregiver 
interactions to accomplish self-identified and mutually agreed upon goals.26,27,49 Regardless of 
whether patients with SCD progress to AD, remain stable, or improve,67 patients and caregivers 
can benefit from DEMA-Pro. 

23-28 
Our proposed study combines multiple sources of data to comprehensively evaluate 
quality and effectiveness of DEMA-Pro when delivered through home healthcare services 
(Aim 3). Use of multiple existing databases to evaluate the quality of home health services for 
patients with SCD is extraordinarily difficult. Our use of combined data from the Medicare 
OASIS electronic health record and from KAH’s Electronic DEMA-Pro care plan is innovative 
and will enable us to meaningfully evaluate DEMA-Pro’s influence on home healthcare quality of 
care. 
 
D. APPROACH: R61/R33 
 
Following the instruction and requirements provided in RFA-18-585, this section includes 
description of: (1) preliminary studies relevant to the R61/R33 phases; (2) a conceptual model; 
(3) detailed methods to assess R61 milestones prior to R33 phase; (4) R33 milestones; and, (5) 
Potential problems and alternative solutions. 
 
D.1. Preliminary Studies. Our combined expertise is necessary for the success of this DEMA- 
Pro pragmatic pilot project. PI (Lu) has developed and led a DEMA program of research 
focused on positive health, strength-based and family-center interventions to improve the 
meaningful activities, physical function, and quality of life of older adults with cognitive 
impairment and their family caregivers in past 15 years. Dr. Hickman (Co-I) has significant 
experience with implementing and evaluating evidence-based interventions for older adults in 
real world clinical settings, including serving as an 8-year Co-I on a Centers for Medicare and 
Medicaid Services funded demonstration project in which they are implementing systematic 
advance care planning in 19 nursing facilities. Dr Haase (Co-I) has extensive experience 
developing psychosocial behavioral interventions and evaluating them in multi-site randomized 
clinical trial. Dr. Ellis (Co-I), Vice-President, Research and Business Development, Kindred at 
Home, has extensive experiences coordinating and leading efforts to guide large-scale 
implementation of healthcare delivery innovation via translation of evidence to real-world 
application in large, complex and highly-matrixed healthcare delivery organizations for over 15 
years. Dr. Perkins (Co-I) is has extensive statistical experience, serving as biostatistician or Co- 
Investigator on 33 funded studies (including NIH). Dr. Jones (Consultant), has successful 
experiences with recruitment and stakeholder engagement in home healthcare setting and 
recently conducting improving care coordination between clinicians to optimize care transitions 
to home health care (AHRQ, K08HS024569). 
 
DEMA-Pro is adapted from DEMA. DEMA was developed using NIH’s Stage Model for 
Behavioral Intervention Development95 across five preliminary studies (T32NR007066, 
P30AG10133-pilot study, K01NR010854, R21NR013755); 
all five studies were consistently 
focused on patients’ and caregivers’ self-identified needs and experiences. The studies 
demonstrated DEMA’s high feasibility and acceptability in home settings. Compared to other 
studies of older adults with cognitive impairment in which completion rates ranged from 60% to 
78%,69-72 we had a 98% consent rate and a 94% completion rate, indicating unusually high 
acceptance, minimal burden, and high intervention value.27,28 This pilot offers the unique 
opportunities to adapt DEMA to the home health service setting, delivered by centralized health 
care professionals and with evaluation support. 
 
Indiana University & Kindred at Home, Gentiva Health Services academic/corporate 
research partnership. Kindred at Home (KAH) is one of the largest home health services in the 
United States (> 400 sites in 40 states).75 Dr. Lu (PI) and KAH Vice President Dr. Ellis have 
collaborated since 2015 on preliminary studies of DEMA, which yielded 2 publications,28,76 1 
manuscript in progress, and 2 poster presentations at national and international conferences.77,78 

In her role as Vice President of Research and Business Development, Dr. Ellis facilitated a 
formal memorandum of understanding (MOU) between IU School of Nursing and KAH to 
collaborate on research and share data (Data Use Agreement No.1153529). This call for pilot 
proposals is timely, since Drs. Lu, Ellis, and the Chief Officers of KAH had already started 
exploring adapting the DEMA program for use in the home health services settings—this 
funding mechanism provides the ideal opportunity to both adapt and rigorously evaluate the 
implementation of DEMA for dissemination both within and potentially beyond KAH. (See 
attached of Letter of Support). 
 
Team experience conducting pragmatic RCTs with Alzheimer’s patient, caregivers, and 
healthcare providers. As an MPI on a R21/R33 APPROACHES pragmatic clinical trial to 
implement an advance care planning intervention for persons with ADRD in nursing facilities 
(R21 AG057463; R33 AG057463), Dr. Hickman established the infrastructure to conduct a 
pragmatic RCT, developed a training plan, collaborated with corporate partners to adapt 
intervention protocols, and is using existing federally collected data (Claims, MDS) along with 
electronic health record (EHR) data to evaluate target outcomes. 
 
 
 
 
 
 
 
 
D2. 
Conceptual Framework (see Figure 1.) A modified Donabedian79 approach to quality 
measurement guides this study. The 4 elements of the model are: 1) context, 2) process, 3) 
systems of care, and 4) outcomes. In this framework, DEMA-Pro is a process that is influenced 
by context (e.g. patients/caregiver characteristics) and systems of care (e.g. the KAH home 
health services sites), to improve intermediate (e.g. meaningful activity engagement) and 
longer-term outcomes (e.g. physical function, QoL, and reduced depression, hospitalization, 
emergency visit, and/or transfer to nursing home rates). 
 
D.3. APPROACH R61 Pilot Phase 
 
Activities to Support Aim 1: Establish the organizational infrastructure and programmatic 
processes needed to conduct a pragmatic cluster-randomized control trial of the DEMA- 
Pro intervention versus usual care. 
 
D.3.1. Establish Memorandum of Agreement. PI Lu and Dr. Ellis will work with the IU Office 
of Research Administration and KAH. Electronic copies of the signed MOU will be securely filed 
in the IUPUI research office and sent to the NIA Agency. In the R61 phase, patient recruitment 
and assessment will be done by Assessment Associates at 4 KAH sites; DEMA-Pro will be 
delivered by protocol-trained personnel at KAH’s Centralized Call Center and the resulting 
DEMA-Pro care plans will be implemented by site clinical staff. 
 
D.3.2. Establish Organizational Structure. As PI, Dr. Lu will oversee all aspects of project 
development, implementation, and analysis including human resources, NIH/NIA Program 
Officer communication, and budgetary decisions. Figure 2 depicts the organizational structure 
for both the R61 and R33 phases. 

 
 
 
 
 
 
 
 
 
 
Steering 
Committee. Responsibilities are: 1) project oversight, including collaboration between IU and 
KAH partners, coordinating workgroup tasks, and achieving project milestones, including 
primary oversight of the pilot pragmatic phase, and transition to the R33 phase; 2) monitoring 
KAH electronic and Medicare OASIS data to ensure quality of all DEMA-Pro outcome data. 
 
Regulatory and Operations Workgroup. Responsibilities are: 1) obtain a signed MOU from 
KAH, Gentiva Health Services for the DEMA-Pro trial; 2) follow the signed data use agreements 
from KAH to ensure access to electronic health record OASIS data80 and other relevant data; 3) 
oversee human subjects’ protection, obtaining Indiana University Institutional Review Board of 
Record (IRB of record) approval, and requesting an informed consent waiver for patients and 
caregivers; 4) coordinate data safety monitoring board (DSMB), convening meetings and 
supporting data safety and monitoring reporting. 
 
DEMA-Pro Intervention Protocol Workgroup. Responsibilities include adapting the DEMA 
protocol, training protocol and toolkits according to KAH’s blended learning modules for use as 
DEMA-Pro to be implemented as a new KAH initiative. In collaboration with KAH Gentiva Health 
Servcies, relevant corporate policies will be reviewed and potentially modified or created to 
support the roll-out of this new initiative. The Chief Officer (O’Sullivan) of KAH Home Health 
Services confirmed her willingness to make modifications to policies and procedures to support 
DEMA-Pro. DEMA training and intervention protocols and toolkits will be revised as DEMA-Pro 
to assure the home health services call-center care coordinators delivering DEMA-Pro coach 
are able to follow the intervention protocol. DEMA-Pro will be refined based on collaboration 
and consensus, national standards, and existing research evidence. 
 
Separate meetings will be conducted with each KAH site (n=4) recruiting participants and with 
home health services corporate leadership to discuss opportunities and potential barriers to 
implementing DEMA-Pro at the site. DEMA-Pro will be refined based on this feedback and 
further reviewed with representatives from all 4 sites. Based on feedback, DEMA-Pro materials 
will be refined and finalized for KAH training and delivery. 
A minimum of three KAH call-center care coordinators will be designated DEMA-Pro coaches 
will receive in-depth training (approximately 8 hours) and hard-copies of the protocol, sample 
template workflows, educational handouts (i.e. Self-Management Toolkits), and tips for 
navigating common barriers. Training will include specific information about the principles of 
problem-solving for patients with SCD and their family caregivers. Core expectations for DEMA- 
Pro include education provided to KAH staff with dedicated time to coordinate and facilitate 
discussions with SCD patients and their caregivers. Based on our previous DEMA study 
personnel training, DEMA-Pro delivery to SCD patients and caregivers requires 60 minutes for 
each of the six weekly calls. Dedicated time and flexible schedules are important for the DEMA- 

Pro coach to facilitate conversations with SDC patients and their caregivers. Consistent with the 
principles of a pragmatic trial, instructions for the DEMA-Pro coach will be highly flexible.81 
 
Per standard operating procedures, a Clinical Assessment Associate at each KAH site will 
collect and enter data into the electronic health record-OASIS. This Associate will receive one- 
hour of training to ensure data collection fidelity at both admission and discharge data collection 
times. In addition, a 20 minutes online video will be provided to other home health services field- 
based staff to orient them to the goals and processes of DEMA-Pro and to support their use of 
the DEMA-Pro care plans with patients in the home setting. These KAH home health services 
field-based staff include registered nurses, physical therapists, occupational therapists, and 
social workers. The DEMA-PRO coach communicate with to the field-based staff through 
electronic DEMA-Pro care plan. Adaptations to the DEMA-Pro Self-Management Toolkit, 
workflows, and educational materials will be made following the pilot. 
 
Data Management and Analysis Workgroup. This group is responsible for obtaining and 
monitoring all KAH facility and patient data. Based on power calculations, we need 40 KAH 
home health services locations (20 intervention and 20 control sites, 25 patients/per site; a total 
of 1000 patients) for the R33 clinical trial phase. This workgroup is responsible for: 1) data 
management required to link data sources in preparation for analysis and for the actual 
analysis; 2) data collection protocol and data transfer processes; and 3) the REDCap data 
management system for the QoL outcome. In Month 2, initial data collection protocol and 
process for integrating KAH electronic data sources will be tested to determine if any data 
revisions are necessary. To assess completeness and accuracy of , an electronic health record- 
OASIS dataset tool,80 will be compared to the KAH hospitalization rate, or/and transfer to 
nursing home rate to determine whether the process of merging was accurate. For example, 
validity checks will be performed to insure all participant hospitalizations and transfers to nursing 
homes are captured. This also will provide an opportunity to pilot test data cleaning procedures 
and initial analytic capabilities of the merged data set. 
 
Activities to Support Aim 2, Pilot test the DEMA-Pro training protocol in 4 KAH North 
Region sites and refine as indicated. 
 
D.3.3.1 Pilot Study Setting. KAH, Gentiva Health Services is a subsidiary of Humana and 
annually provides home health services to >500,000 patients at > than 400 United States sites 
in over 40 states.75 KAH employs teams of clinicians who provide in-home visits with the support 
of clinicians who provide support and monitoring by phone from the KAH-wide call-center. Call- 
center care coordinators will deliver DEMA-Pro intervention via telephone. The expected 
outcome of each session is a DEMA-Pro plan/revised plan for engagement in meaningful 
activity over the next week. The home health field-base staff will review the electronic weekly 
DEMA-Pro care plan with participants and support patient and caregiver engagement in 
meaningful activity according to latest plan. See Table 1 for R61 (pilot) phase potential number 
of staff and admissions rates at potential sites. 
 
Table 1. R61 KAH North Region Sites and Numbers of Site Staff and Patient Admissions 
in 2018 
Location 
Number of Staff* 
2018 Patient Admissions 
North Region Location No. 1 
20 
659 
North Region Location No. 2 
20 
554 
North Region Location No. 3 
38 
900 

North Region Location No. 4 
18 
347 
Total 
96 Staff 
2460 Patient Admissions 
*Staff includes nurses, physical therapists, occupational therapists, and speech therapists. 
D.3.3.2. R61 Study Population. There are two study populations. 
1) KAH staff including call-center care coordinators, clinical assessment associates, field- 
based therapists, and clinical operational coordinator; 
2) Home health service patients aged > 60 years with SCD, with an OASIS- Cognition 
Function Subscale Score of 1 or 2 (0 = alert/oriented, able to focus and shift attention, 
comprehends and recalls task directions independently; 1 = Requires prompting [cuing, 
repetition, reminders) only under stressful or unfamiliar conditions; 2 = Requires assistance and 
some direction in specific situations [for example, on all tasks involving shifting of attention] or 
consistently requires low stimulus environment due to distractibility; 3 = Requires considerable 
assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall 
directions more than half the time; 4 = Totally dependent due to disturbances such as constant 
disorientation, coma, persistent vegetative state, or delirium. 
 
D.3.3.3. R61 Data Elements. 
Data elements include home health services characteristics (size, rural/urban location), patient 
characteristics (demographics, cognitive status, and functional status), patient outcomes, and 
feasibility of DEMA-Pro training and delivery. Consistent with the principle of pragmatic clinical 
trials,82,83 primarily existing data will be used to evaluate outcomes. See Table 2 for Outcomes, 
Measures and Electronic Data Sources. 
 
The primary study outcome is physical function, assessed using existing OASIS Activity Daily 
Living and Instrumental Activity Daily Living (ADL/IADLs) subscales.80 Secondary outcomes are 
QoL, depression, the rates of hospitalization, emergency room admission, and transfers to a 
nursing home. We will use OASIS to assess rates of hospitalization, emergency room visits, and 
transfer to nursing home.80 QoL (Sense of Well-being) will be measured with the NIH Toolbox- 
Psychological Well-being Short-From.84,85 Depression will be assessed using the OASIS-PHQ-2 
subscale. DEMA-Pro training acceptability, delivery confidence, and ability to meet goals will be 
assessed using of the existing KAH online learning management system and tools and will be 
analyzed by the Data Management Workgroup. 
 
Table 2. R61 Data Elements: Patient, Staff, and Outcomes 
Patient Data 
Measure(s) 
OASIS-Da 
Other 
Sources 
Demographics 
Patient Characteristics 
M0010, M0014, M0020, 
M0030, M0050, M0066, 
M0069, M0140, M0100, 
M1000, M1021; M1023, 
M1028, M1033, M1100, 
M1200 
Cognitive status 
Cognitive Function 
M1700 
DEMA-Pro care plan 
DEMA-Pro Care Plan and Daily 
Meaningful Activity Log 
KAH -DEMA- 
Pro care 
plan b 
Staff Data 
Staff Experiences of DEMA- 
Pro training and delivery 
Feasibility and Acceptability of DEMA- 
Pro training and delivery survey 
KAH LMSc 
Outcomes Data 

Physical Function, 
(Primary Outcome) 
Activities of Daily Living/Instructive 
Activities of Daily Living 
M1800, M1819, M1820, 
MM1830, M1840, 
M1845, M1850, M1870, 
QoL (Sense of Well- 
Being) 
NIH ToolBox: Psychosocial Well-being- 
Short-Form 
REDCap 
Depression 
PHQ-2 
M1730 
Hospitalization Rate 
Frequency of rehospitalization rate 
M2410 
Number, Types of ER 
visits 
Frequency unplanned urgent care or 
hospital ER care 
M2301, M2041 
Nursing Home Transfers 
Frequency of transfers to nursing home 
care 
M2410 
aOASIS-D = Outcome and Assessment Information Set Data; bKAH electronic DEMA-Pro Care 
Plan; cKAH LMS = Kindred at Home Learning Management Systems. 
 
D.3.3.4. R61 Data Collection Protocol. Patient data will be obtained by a KAH Clinical 
Assessment 
Associate at start of care date, date of any re-admission, and discharge date, using existing 
KAH electronic data sources including electronic health record-OASIS, Electronic DEMA-Pro 
Care Plan, learning management system (LMS) and REDCap. 
 
Staff data related to orientation, training, DEMA-Pro delivery and data collection will be obtained 
from DEMA-Pro coaches, Clinical Assessment Associates, and home health field-based 
staff. The KAH call-center Care Coordinator will complete the Weekly Activity Engagement 
Form through the electronic KAH E DEMA-Pro care plan data are used by KAH to identify 
quality improvement opportunities, evaluate the quality of service provided and guide 
operational decisions. Items specific to DEMA-Pro outcome s (i.e., QoL) will be added to the 
KAH home health services REDCap system. KAH staff perception of feasibility of and 
satisfaction with DEMA-Pro training and delivery survey questions will be added to and entered 
into KAH LMS. 
 
To establish acceptability of the blended learning modules to train home health providers to 
deliver DEMA-Pro, the Intervention Protocol Workgroup will: 1) review corporate policies 
relevant to DEMA-Pro implementation at KAH; 2) adapt the DEMA intervention protocol, training 
protocol, and Self-Management Toolkit, into blended learning modules and training materials; 3) 
develop the 15-minute orientation video for KAH home health services field-based staff in 
Month 4, at the KAH Education/Training Center in Atlanta, and 4) work with KAH clinical 
operational coordinators to ensure the training protocols are aligned with KAH policies. 
The Data Management and Analysis Workgroup will: 1) integrate the feasibility and satisfaction 
survey questions of DEMA-Pro training and delivery into the KAH online system; 2) ensure the 
KAH trained staff (i.e. call-center care coordinators, clinical assessment associates, home 
health service field-based staff) complete the feasibility DEMA-Pro training survey after training 
sessions and the satisfaction survey (within 48 hours of completing training session) in the KAH 
online system as following the KAH policies; 3) complete the survey data analysis; and 4) 
provide the results to the steering committee and the funding agency quarterly. PI Lu and the 
project manager will work with the DEMA-Pro intervention protocol work group to train KAH staff 
using the modified training protocol, developed blended teaching modules, and training 
materials. 
 
To assess feasibility of the DEMA protocol as delivered by trained call-center care coordinators, 
PI Lu will work with the Project Manager and the DEMA-Pro Intervention Protocol Workgroup to 

ensure trained KAH call-center care coordinators can follow the DEMA-Pro protocol and deliver 
the sessions through telephone. 
To assess acceptability and quality of study data using the electronic health record- OASIS 
data collection tool, KAH Electronic DEMA-Pro care plan, and other measures (e.g., QoL), Dr 
Lu, the (TBD) Project Manager, and the Data Management and Analysis Workgroup will: 1) 
extract necessary home health services OASIS administrative data, and generate preliminary 
statistics; 2) access the acceptability and quality of study specific data such as electronic health 
record from the OASIS data set, the KAH electronic DEMA-Pro care plan, the REDCap Data 
(e.g. QoL), and KAH online learning management system (e.g. feasibility of DEMA-Pro training 
and delivery survey data). 
 
D.3.3.5. R61 Intervention Monitoring data will be obtained and monitored within the DEMA- 
Pro REDCap and KAH electronic DEMA-Pro care plan data bases, as modified by the Steering 
Committee. These modifications are necessary both to monitor the use of the intervention and 
to support best clinical practice. A goal will be to minimize the burden on staff and maximize the 
integration of monitoring into existing clinical systems, consistent with the goals of a pragmatic 
clinical trial. Specifically, the KAH electronic DEMA-Pro care plan will capture: 1) When a 
DEMA-Pro is held; 2) what is discussed (check box), 3) who are involved; 4) length of 
discussion, and 5) outcomes (e.g. code status documentation “Weekly Activity 
Engagement”). The DEMA-Pro coach will be given an assignment list of 5 home health patients 
with SCD with a total of 20 telephone session monthly approach; the project staff will work with 
the DEMA-Pro coach and the KAH Clinical Operations Coordinator to determine procedures for 
generating this monthly assignment list. If a patient or family caregiver is approached by phone, 
but declines or does not engage (e.g., passive refusal) after three phone call attempts, the 
DEMA-Pro coach will document this outcome in the electronic DEMA-Pro care plan. 
 
D.3.3.6. R61 Phase Data Analysis. Analytic Plan. Aim 1 will not require quantitative analysis. 
The data collected for Aim 2 will be analyzed with descriptive methods. Item responses will be 
tabulated and scale scores for acceptability and feasibility summarized by means and standard 
deviations (or medians and 25th and 75th percentiles if the data is skewed). Acceptability, 
feasibility, and satisfaction data will be summarized separately for DEMA-Pro coaches, clinical 
assessment associates, and home health field-based staff. With respect to patient outcomes, 
our primary goals are to examine the data collected from the EHR for quality and ensure it can 
be captured and merged efficiently and appropriately. We will also generate descriptive 
statistics for all patient outcomes collected through the EHR to help us to identify any data 
issues, such as missing data patterns, that could influence the implementation of the pragmatic 
RCT. Cronbach’s alpha will be calculated for multi-items scales. 
 
D.3.3.7. R61Go/No-Go Criteria, Milestones and Timeline. The Go/No-Go Criteria are 
established per the RFA guidance to identify the milestones that must be achieved during the 
R61 phase to qualify for the transition from the R61 to the R33 phase. The R61 Go/No-Go 
criteria are: 1) Establish partnerships with the KAH home health services as demonstrated by 
executed memoranda of understanding and data use agreements; 2) Obtain access to 
necessary administrative data including OASIS, KAH electronic DEMA-Pro care plan, REDCap 
and KAH LMS; 3) Produce the DEMA-Pro protocol; and 4) Pilot test the DEMA-Pro Program 
and generate preliminary feasibility data. Milestones and the study timeline are in Table 3. 
 
Table 3. R61 (Pilot) Milestones and Timeline. 
Milestones 
Months: 1 2 3 4 5 6 7 8 9 10 11 12 
Start-UP: hire staff, obtain IRB approvals; establish goal timelines the 
Steering Committee and the three Workgroups 

Obtain MOU with the KAH, and establish DMSB 
Submit data access requests to: HHS for OASIS database and to KAH 
for access to DEMA-Pro care plan and LMS data bases 
Identify pilot sites and DEMA Program interveners, Review/adapt HHS 
EHR policies and procedures. 
Refine DEMA in-person training delivery to blended learning 
models for DEMA-Pro 
Pilot test DEMA-Pro training and revise as needed 
Access and analyze process and outcome data from OASIS and KAH 
DEMA-Pro care plan and LMS databases 
Extract, link and verify accuracy of data 
Assess value of and ease of obtain outcomes measures for use in R33 
Note: IRB = Institutional Review Board; MOU = Memoranda of Understanding; HHS = Home Health 
Services; EHR= Electronic Health Record; DSMB = Data Safety and Monitoring Board; OASIS = 
Outcome and Assessment Information Set; LMS = Learning Management System; DEMA-Pro = Daily 
Engagement Meaningful Activity Professional