Innovative Care of Older Adults With Chronic Heart Failure (I-COACH): A Comparative Effectiveness Clinical Trial
Phase: NA
Conditions: Heart Failure
Sponsor: University of Arkansas

Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
IRB Approval Date: August 11, 2021
NCT04304833 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 1 
Date:  7/30/2021 
 
Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I- 
COACH): A Comparative Effectiveness Clinical Trial 
Principal Investigator: 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 529 
Little Rock, AR 72205 
Telephone: +1 (501) 296-1939 
Email: LeflerLeanne@uams.edu 
Co-Investigator (s): 
Sarah J. Rhoads, PhD 
University of Tennessee Health Sciences Center 
College of Nursing 
874 Union Ave, Suite G001 
Memphis, TN 38163 
Telephone: +1 (901) 448-3176 
Email: srhoads@uthsc.edu 
Tiffany Haynes, PhD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 820 
Little Rock, AR 72205 
Telephone: +1 (501) 526-6613 
Email: TFHaynes@uams.edu 
Joseph Sanford, MD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 728 
Little Rock, AR 72205 
Telephone: +1 (501) 686-7860 
Email: JASANFORD@uams.edu 
Songthip Ounpraseuth, PhD; Co-I & Statistician 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 781 
Little Rock, AR 72205 
Telephone: +1 (501) 686-7233 
Email: STOunpraseuth@uams.edu 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 2 
Date:  7/30/2021 
 
Srikanth Vallurupalli, MD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 532 
Little Rock, AR 72205 
Telephone: +1 (501) 686-5886 
Email: SVallurupalli@uams.edu 
Jean McSweeney, PhD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 529 
Little Rock, AR 72205 
Telephone: +1 (501) 296-1982 
Email: McSweeneyJeanC@uams.edu 
Jing Jin, MPH; Statistician 
UAMS College of Public Health, Biostatistics Department 
4301 W. Markham Street 
Little Rock, AR 72205 
Phone: 501-526-6735 
E-Mail: JJIN@uams.edu
Study location: 
University of Arkansas for Medical Sciences 
Funding: 
PCORI Grant 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 3 
Date:  7/30/2021 
 
Table of Contents 
Table of Contents ............................................................................................................ 3 
Background and Rationale .............................................................................................. 4 
Specific Aims and Hypotheses ........................................................................................ 5 
Study Design and Procedures ......................................................................................... 6 
The provider-directed management model .................................................................. 7 
The mHealth care management model ........................................................................ 8 
Outcome Measures and Measurement Procedures .................................................. 10 
Compensation ........................................................................................................... 10 
Study Population ........................................................................................................... 12 
Inclusion Criteria ........................................................................................................ 12 
Exclusion Criteria ....................................................................................................... 12 
Risks and Benefits......................................................................................................... 13 
Data Handling and Recordkeeping................................................................................ 13 
Data Analysis ................................................................................................................ 14 
Ethical Considerations ................................................................................................... 17 
Dissemination of Data ................................................................................................... 18 
References .................................................................................................................... 18 
Appendices ................................................................................................................... 22 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 4 
Date:  7/30/2021 
 
Background and Rationale 
An estimated 6.5 million adults in the U.S. have heart failure (HF) with an estimated cost 
of >$30 billion annually and projections show that the prevalence will increase 46% by 
2030, because of population aging.11 One- and five-year fatality rates after HF 
hospitalization are exceptionally high at 22% & 42%.11 HF is characterized by poor 
quality of life due to a trajectory of worsening symptoms until death, but HF is amenable 
to management and prevention of symptoms. 12, 13 When symptoms occur, it is an 
indicator that hemodynamic measures are out of normal range, which requires 
intervention before symptoms accelerate into a patient crisis requiring emergent medical 
intervention.13 The most common HF symptoms also serve as warnings for impending 
crisis: chest pain, dyspnea, edema, fatigue, orthopnea, and anxiety/fear.13
The amount of support available from providers to manage daily patient symptoms and 
complications is far beyond what is feasible during episodic primary care provider 
visits.14 Self-care patient behaviors are well known to improve HF outcomes; however, 
self-care is underutilized and underappreciated while pharmacological interventions are 
seen as more important by patients, clinicians and healthcare systems.15
Recommended self-care behaviors are: accurate and timely symptom perception, daily 
management and ongoing preventive maintenance to include behaviors such as 
smoking cessation, maintenance of normal weight, regular physical activity, reducing 
dietary sodium, decreasing alcohol use, maintaining a healthy diet and cholesterol, 
monitoring blood pressure (BP), and blood glucose.15 Other prevention actions include 
annual dental exams, flu shots, health screenings and check-ups. The complex needs 
of these patients require a new vision and paradigm for delivery of health care services, 
such as an Mobile Health (mHealth) management model. mHealth technologies such as 
blue-tooth enabled BP, heart rate, weight, and pulse oximetry (POx) remote monitoring 
permit sharing of immediate real-time biometric data and video messages with providers 
& delivery of instantaneous feedback to patients before symptom crises.16
mHealth interventions have been studied worldwide in >30 low-and middle-income 
countries.17 Recent meta-analyses and systematic reviews agree mHealth monitoring is 
generally effective in reducing HF hospitalization18-23 and short term mortality.17-21, 23, 24
Research is more limited and often equivocal but found somewhat effective in 
improving quality of life,19, 20, 23-27 medication adherence,17 cardiac lifestyle behaviors 
and disease management,17, 19, 27 and sometimes patient satisfaction.20 Most studies 
used hospitalizations and mortality as primary outcomes and gaps in knowledge remain 
with important patient-centered outcomes, such as self-care, symptom management, 
functional capacity, psychological distress, and caregiver burden.16, 25, 28-30 Additionally, 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 5 
Date:  7/30/2021 
 
most studies did not stratify outcomes according to demographic variables23 or engage 
samples that were sufficiently racially/ethnically diverse.23, 27
mHealth technologies have established efficacy in the care of patients with HF, yet 
there is a decisional dilemma because HC systems, providers and payers do not know 
which care model should be used for a particular patient profile according to severity of 
HF, co-occurring multi-morbidities, or other patient characteristics or living situations, 
etc. Prevailing gaps in knowledge remain: Which patients will a mHealth model would 
work better than the traditional provider-directed model for management of HF? 
Considering patient-centered outcomes, which model improves outcomes important to 
patients, such as function, symptom control, distress, quality of life, and caregiver 
burden? 
Specific Aims and Hypotheses 
Aim 1. 
The principle aim of our proposed clinical trial is whether an enhanced mHealth care 
management model with connected health technology used in partnership with the 
healthcare system team, an older person with heart failure (HF), and their caregiver are 
more effective than a provider directed management model using non-connected home 
equipment kits. Self-care of HF, quality of life and quality care are represented by 
multiple outcome measures that are important to patients, caregivers and healthcare 
(HC) systems. Specifically, 
Aim 1a. Patient-centered outcome measures: We hypothesize that the mHealth 
model will increase measures from baseline to 3- and 6-month for the primary 
outcome of self-care management of HF1 compared to the provider-directed model. 
Further, we hypothesize that the mHealth model will increase measures from 
baseline to 3- and 6-month for secondary outcomes of Self-efficacy to manage 
symptoms, medications, & treatments2; self-care confidence2; physical function, 
sleep, social roles, (Promis 43v2.1 Health profile3); heart failure knowledge;4
satisfaction with care5; quality of life6; informational support3 and equipment usability 
(3 and 6 months),3, 7while decreasing health distress,8 anxiety, depression, fatigue, 
and pain3 compared to the provider-directed model. 
Aim 1b. Caregiver outcome measures: We hypothesize that the mHealth model will 
reduce caregiver burden,9 while increasing caregiver health10 compared to the 
provider-directed model from baseline to 6-months. 
Aim 1c. Health system outcome measures: We hypothesize that the mHealth model 
will reduce hospital admissions, 1-month readmissions, emergency department 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 6 
Date:  7/30/2021 
 
visits, and 6-month mortality of HF participants while increasing satisfaction with 
care,5  compared to the provider-directed model. 
Aim 2. 
We aim to explore associations of outcome measures with certain patient 
characteristics to determine which patients benefit the most from each care model, 
considering important patient-centered characteristics such as function, HF severity, 
rurality, and other demographic characteristics; and considering location of caregivers, 
and HC system outcomes such as emergency department visits and readmissions. 
Aim 3. 
We aim to explore whether changes in self-efficacy,2 HF knowledge,4 and/or skills1
mediate the effect of self-care management.1
Study Design and Procedures 
This will be a single-blinded comparative effectiveness randomized controlled trial 
conducted in a real-world setting. Subjects with HF and their caregivers (dyads) will be 
recruited and randomly assigned to one of two study arms: 
•
a provider-directed management model (with home monitoring equipment), a
standard care-plus, OR
•
an enhanced-mHealth care management model (with connected monitoring
equipment).
Both groups will receive HF guideline-directed usual care, defined by the American 
Heart Association and College of Cardiology HF Guidelines13 with widely demonstrated 
effectiveness12 and have the same opportunity for education, nutrition counseling, nurse 
management, and HC provider access. This is usual care at UAMS. 
Recruitment: Research participants will be recruited consecutively from the UAMS 
Medical Center. The project director will receive a daily list from UAMS bioinformatics 
core via UAMS secure/encrypted email of patients admitted to the hospital with a 
primary or secondary diagnosis of heart failure. Patients will be visited by the research 
team when they are stable and likely the day of discharge from the hospital (that way, 
likely the family/caregiver will be here as well). At that time, information will be given to 
the patient (and family/caregiver if present) about the study. If they would like to, we will 
obtain consent from both the patient and the caregiver if agreeable. Alternatively, they 
can think and talk about whether they want to participate and we will follow up after 
return home. 
See section on participants and human subject protection for more details on 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 7 
Date:  7/30/2021 
 
recruitment & consent. 
The randomization will be generated using a computer algorithm using random 
permuted blocks (of differing size) to ensure balance over time in the numbers allocated 
to intervention groups and to avoid study staff anticipating the next treatment allocation. 
Randomization will be centrally generated by Co-I Ounpraseuth and study staff who 
allocate interventions will be blinded to both the sequence and size of the blocks. 
Participants will be randomized then they will complete baseline measures (self- 
reported survey measures, see Table 1.). Because all participants & caregivers will 
participate in the same recruitment procedures, measure timelines, and will receive 
monitoring equipment, participants will be blinded to their assigned group and will not be 
informed of which is the active intervention group. Both groups will receive standard 
education provided by the hospital and clinic providers, in addition the study staff will 
emphasize portions of the standard education provided regarding emergency situations 
that require immediate action from the patient and/or caregiver such as; hypertension 
crisis, stroke signs and symptoms, and signs and symptoms of heart attack.  
The provider-directed management model is the current standard of care in the 
treatment of patients with HF including guideline-based HF care and a fee-for-service 
payment model in which the number of services and procedures that are provided are 
billed. Patients are typically scheduled for provider visits at a periodic interval rather 
than on patient needs, preferences, or circumstances.36 Care delivery is based on 
convenience of provider and sometimes on priority-based queues, that is If patients are 
having problems, they typically call the providers office or set up an appointment to visit 
the clinic weekdays and get priority scheduled. If problems occur at a different time, 
they frequently go to the emergency department (ED) at a local hospital36 or UAMS. 
Caregiver burden is substantial in this model considering the patients’ problem solving, 
care, and transportation needs.16 Our previous research35 confirmed both the traditional 
call/wait approach and ED alternative as usual means of provider communications. 
However, in this study, we are supplementing standard care by providing and training 
each patient in the use of an analog kit: (not internet connected) weight scale, blood 
pressure cuff, pulse oximeter, and a Log for recording their vital sign measures. Patients 
will be trained on the equipment and told to obtain a reading of weight, BP, and POx 
saturation every morning when they arise. Participants will make appointments, receive 
consultations, case-management, and resolve problems through in-person 
appointments or telephone communications as usually scheduled during the 6-month 
study follow-up. 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 8 
Date:  7/30/2021 
 
Subjects will be instructed to record their daily readings on a paper log provided by the 
research team. These monitoring devices will not transmit readings to a centralized  
location and no one will be alerted to out-of-range readings or compliance with taking 
daily vital sign measures. At the front page of the log, normal ranges will be described 
with brief instructions about what participants/caregivers should do if their readings are 
out-of-range. These instructions will be developed with guidance from 
physicians/providers in the cardiology department. Per protocol, participants will be 
instructed to telephone the provider’s office or the standard “on-call” line for further 
consultation and evaluation as needed. The number of provider visits will be collected 
using the electronic medical record and patient self-report). Patients will be encouraged 
to bring their vital sign measure logs to their provider appointments. Logs will be 
collected at the completion of their participation in the study. The log data will be 
recorded and saved for further data analysis. 
The mHealth care management model. We will provide each patient randomized to 
this group with a weight scale, blood pressure cuff, & pulse oximeter (POx) kit 
connected to a Bluetooth-paired Android Health Tablet over the 6 months. This will 
allow real-time collection and monitoring of patient's vital sign measures, instantly 
accessible 24 hours a day, every day, by both patients and their clinicians, via a 
wireless gateway that transmits readings to a secure cloud-based clinician portal. The 
clinician portal will be monitored by the hospital’s call center where registered nurses 
(RNs) will be specially trained to triage these patients according to physician/provider 
and study team-developed protocols. 
Patients will be trained on the equipment and obtain a reading of weight, BP, and 
symptom survey every morning when they arise. A POx saturation reading will be 
obtained as needed. We used identical procedures in our pilot study and reported high 
patient daily adherence (85%) and call center accuracy (90%).35 Patients have the 
option to receive patient-centered education, nutrition counseling, nurse & medication 
management, and problem-based medical visits through live audio and video connected 
technology in their home. Diagnostic testing and some problems, if needed, will 
necessitate a visit to a local laboratory, regional UAMS clinic or main campus as usual. 
Caregivers will be encouraged to attend sessions or telehealth appointments from any 
location virtually. We will work with the providers, case managers, and our hospital 
system to train for telehealth visits as well as coding and billing. 
Vital sign readings will be sent to the secure cloud-based software. Patients will be 
encouraged to take their vital signs daily. If the readings are out-of-range, the 
Registered Nurse (RN) Call Center will be automatically alerted via an email message. 
Protocols were developed by the medical providers as to acceptable and unacceptable 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 9 
Date:  7/30/2021 
 
vital sign ranges/readings and actions. (We did this with the pilot study, and the 
procedure worked well). If within normal range, no intervention would be needed, and 
readings will be saved for future data analysis. This is considered a “green light”, that is 
no alert is triggered and no intervention is needed. 
If readings are missed or trending out of range, or out of range now, the call center RN 
will follow the provider/study team developed protocol or algorithm for “yellow light” 
“orange light” or “red light”, in order of severity. The call center will monitor patients 
Monday-Friday 7-4pm as per the provider developed protocol. Patients will be 
instructed on what to do outside of those hours.  
A “yellow light” alert means that the readings may begin to trend close to abnormal (too 
high or too low), or that the participant forgot to take the readings for that day. These 
patients will be flagged for follow-up. Yellow light follow up: RN call center reviews the 
new readings and if the trend has not continued, then no action will be taken. If the 
participant remembered to take his readings and they are within ranges set, no action 
will be taken. Participants will be encouraged to take readings daily but will not receive 
a call until they have multiple missed readings per provider developed protocol. 
If the additional readings are “out of range” per protocol, then this is an “orange light” the 
RN call center nurse will telephone the participant and follow protocol. 1) for a missed 
readings: “inquired as to why they have been missing readings and ask the patient to 
take a reading now” if ok, no action will be taken and this encounter will be recorded. 
If vital sign readings are abnormal, they will first check (per orange-light protocol) that 
the patient took the readings properly and that they took their medications that morning 
as usual before readings were taken. The RN will direct the participant to retake the vital 
signs after sitting for 15-30 minutes (per national guidelines), inquire if they have taken 
blood pressure/diuretic medication yet that day, and how they are feeling. Per yellow 
and orange-light protocol, if the preceding has not been done and readings are retaken 
and are normal, no further action will be taken. The encounter will be recorded by the 
call center RN. The Call Center will also direct the patient to follow protocols prescribed 
to them by their cardiology provider, such as the diuretic protocol for fluid 
retention/weight gain.  
If the readings continue to trend out of range, this is considered an “orange light” and 
the provider/clinic will be notified by the call center RN of the information collected and 
vital signs and information recorded in EPIC and will be handed off to the provider to 
follow up as needed for medical care, this will occur M-F 7 am to 4 pm. During triage of 
an “orange light,” the Call Center will also direct the patient to follow protocols that are 
prescribed to them by their cardiology provider, such as the diuretic protocol for fluid 
retention/weight gain. 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 10 
Date:  7/30/2021 
 
At that time, the participant’s treatment plan may be altered by the provider to include 
increased vital sign tele-monitoring for that day, a change in medications, a video 
telemedicine home or in person office visit, or instructions to report to the emergency 
department for immediate evaluation and treatment if needed. The study team will not 
interfere with medical treatment and will not determine medical treatment. They will 
instruct the participant to follow prescribed protocols from their provider.  
A “red light” is considered severe symptoms and/or critically abnormal vital signs. These 
patients are instructed at enrollment in the study about emergencies that require 
immediate action (call 911 or go to the local emergency department) without waiting for 
a call from the call center, such as hypertension crisis, stroke signs and symptoms, and 
signs and symptoms of a heart attack.  
The call center will follow up on red alerts to make sure the participant followed standard 
education previously provided regarding emergencies and reeducate them and their 
caregiver as needed. As with all triage calls, this will be documented in the medical 
record.  
If a yellow, or orange light occurs, and the participant does not answer the phone, the 
caregiver will be called. The caregiver will be instructed to make contact with the 
participant to return a call to the call center for instructions. If participant and caregiver 
are not available, a message will be left about the readings with instructions to 
telephone the call center number as soon as possible. A second call to the home and 
caregiver will be done this day if a return call is not received and same protocol will be 
followed as above. If no answer and no return call, this procedure will be followed per 
call center triage protocol.  
mHealth participants will be told they can contact the call center RN for problems or 
concerns using the tablet or telephone and these will be triaged by RN call-center per 
protocol. Daily vital sign measures, recommendations, and responses will be 
transmitted, provider visits counted, tabulated and saved for analyses. 
Outcome Measures and Measurement Procedures 
Measurement instruments are included in Table 1 (next page) and grouped for the 
patient, caregiver, and system measures, specific aim addressed and type of outcome 
measure. 
After screening to determine eligibility and fully informed consent process is followed 
and obtained, participants and caregivers will be randomized and asked to complete 
baseline assessments. Participants in both groups will be allowed to take assessment 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 11 
Date:  7/30/2021 
 
questionnaires home to fill out within 1 week (+/- 1 week). The Research Assistant (RA) 
will travel to the participants’ home, will be available by phone, or will arrange a 
convenient time before or after a closely timed provider appointment to complete the 
measures and train on use of the equipment. We will offer these convenience 
techniques at baseline, 3- and for the final 6-month follow-up measures. 
Compensation 
Participants and Caregivers will receive compensation for each measurement interval to 
thank them for their time and to encourage completion of the study. Participant 
incentives will be $25 each for baseline and 3-month measures, and $50 for the final 6- 
month measure (for a total of $100). Caregiver compensations are $25 each at baseline 
and at 6-months (total $50). Participants and Caregivers will also be reimbursed for gas 
mileage expense ($.58 per mile per PCORI standards). 
Language 
Instruments will be provided for English and Spanish-speaking patients, may be read to 
the participants if desired, and will be installed with large print and/or an easy-to-use 
format loaded on the tablet device. Outcome data/measures for the provider and 
hospital system will be obtained from the electronic medical record and hospital 
computer database within 30 days after the 6-month follow-up measures have been 
completed. 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 12 
Date:  7/30/2021 
 
Table 1. Specific Aim Addressed, Measure, Outcome Type, Purpose of Measure, Administration Interval & Estimated 
Participant Completion Time 
SP. 
AIM 
Measure 
Outcomes 
Purpose of Measure 
Base 
line 
3 mth 6 mth 
Completion 
Time 
PATIENT CENTERED OUTCOME MEASURES 
1a 
Self-Care of HF Index v7.2 
Primary Outcome: 
Assess self-care management, symptom 
perception & maintenance skills 
X 
X 
X 
8 min. 
3 
Self-Care Confidence 44
Hypothesized Mediator: Assess confidence in ability to care for self 
X 
X 
X 
3-5 min. 
3 
Promis® Self-Efficacy to 
Manage Symptoms 3 
Hypothesized Mediator: 
Assess ability to manage symptoms for 
chronic conditions 
X 
X 
X 
15-20 min.
3 
Promis® Self-Efficacy to 
Manage Medications & 
Treatments3 
Hypothesized Mediator: 
Assess ability to manage medication & 
treatments for chronic conditions 
X 
X 
X 
20 min. 
3 
Dutch HF Knowledge Scale4
Hypothesized Mediator 
Assess Knowledge of HF 
X 
X 
X 
5 min 
1a & 2 
Promis® 43v2.1 Health 
profile 3, 49 
Secondary Outcome 
Patient Characteristics 
Assess physical function, anxiety, 
depression, fatigue, sleep, social roles, and 
pain 
X 
X 
X 
10-20 min.
1a 
Health Distress 8
Secondary Outcome 
Patient Characteristics 
Assess psychological impact/health 
distress 
X 
X 
X 
1-3 min 
1a 
Promis® Informational 
Support v 2.0 6a 3
Secondary Outcome 
Assess perceived availability of helpful 
information or advice 
X 
X 
X 
2-4 min. 
1a 
System Usability Scale 7
Secondary Outcome 
Ease of using the technology 
X 
X 
3-5 min. 
2 
St. Louis University Mental 
Status (SLUMS) 
Examination41
Secondary Outcome: 
Patient Characteristic 
Cognitive assessment (OBJECTIVE 
MEASURE) 
X 
10 min. 
2 
Patient Demographics (self- 
report & medical record 
review) 
Secondary Outcome: 
Patient Characteristics: 
Education, income, rurality, HF severity, 
years diagnosed, caregiver location, etc 
X 
5 min. 
1a 
Minnesota Living with HF 
(MLHFQ)6, 51 
Secondary & Long-Term 
Outcome 
Assesses Quality of Life 
X 
X 
5-10 min. 
2 
Newest Vital Sign60
Secondary Outcome: 
Patient Characteristics 
Screens for Health Literacy 
X 
5 min. 
CAREGIVER CENTERED OUTCOME MEASURES 
1b 
Caregiver Burden 9
Secondary Outcome 
Assess caregiver perception of burden 
X 
X 
30 min. 
1b 
Optum ®SF-36® v2 Health 
Survey52 
Secondary Outcome 
Health domains- Functional Psych. Health 
& Well-being 
X 
X 
5-10 min 
PROVIDER & HEALTH SYSTEM MEASURES 
1c 
Satisfaction with Care5
Secondary Outcome 
Patient assesses satisfaction with care 
X 
X 
X 
1-3 min 
1c & 2 
Hospital, Emergency Visits, 
Provider Visits, Mortality 
Secondary Outcome 
Counts from Medical Record 
X 
X 
X 
N/A 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 13 
Date:  7/30/2021 
 
Study Population 
A sample of 400 patients with HF and their caregivers (dyads, a total of 800 subjects) 
will be recruited using consecutive recruitment from the UAMS hospital and clinics.  
We will employ a rolling recruitment strategy until target sample is reached and will 
consistently monitor progress in recruitment. 
Inclusion Criteria HF Participants 
•
Adults aged > 55 years with HF (documented in medical record).
•
Has capacity to understand informed consent.
•
Able to stand (briefly) without assistance.
•
Has a designated caregiver.
•
Agrees to be followed (treated) by UAMS physician/provider for 6 months after
discharge.
•
Community dwelling
Exclusion Criteria HF Participants 
•
Speaks a language other than English or Spanish.
•
Active psychosis or other severe cognitive disorder that interferes with capacity
to understand and comply with study procedures.
•
A history of drug or alcohol abuse impacting their health with an emphasis on
drugs that cause hemodynamic fluctuations in the past 90 days (documented
in medical record by their provider).
•
Currently residing or being discharged to an in-patient rehabilitation facility,
Long Term Care facility or Assisted Living, and/or Hospice care.
•
Current COVID + infection, or on other contact isolation.
Inclusion Criteria Caregivers 
•
Self-identifies as a caregiver to the HF participant
•
Adult 18 years of age or over
Exclusion Criteria Caregivers 
•
Speaks a language other than English or Spanish.

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 14 
Date:  7/30/2021 
 
Risks and Benefits 
A risk to study participants is the potential for loss of confidentiality of study data. 
Measures to protect the confidentiality of study data will be implemented as described in 
the Data Handling and Recordkeeping section below. Other risks to participants in this 
study are minimal. We will minimize risks to the participants by using procedures 
already being performed with the subjects for diagnostic or treatment purposes, and we 
will only monitor the number of provider and hospital visits via the medical record. The 
medical management of the HF patients will not be changed or dictated in any way by 
this proposed research; only the mode of delivery, and only when applicable. If the 
participant needs diagnostic testing or an in-person appointment as determined by the 
provider, we will not dissuade or intervene in any way. 
All participants will receive standard education provided by the hospital and clinic 
providers, in addition the study staff will emphasize portions of the standard education 
provided regarding emergency situations that require immediate action from the patient 
and/or caregiver such as; hypertensive crisis, stroke signs and symptoms, and signs 
and symptoms of heart attack. Participants and caregivers will be instructed to take 
immediate action by calling 911 or going to the local emergency department without 
waiting for a call from the call center. 
We have a 24-hour RN call center that mHealth participants may contact if questions or 
problems, or they can contact their providers as they have in the past, using standardly 
developed procedures, such as calling the provider’s office number or the “on-call” 
number if after hours. The call-center has been in existence for >10 years and has 
highly skilled RNs that are accustomed to handling issues/problems. Participants in the 
provider-based model will continue with standard access to their providers. 
There will be no direct benefits to the study participants; however, knowledge gained 
from the study could potentially benefit patients in the future. 
COVID -19 Research Guidelines 
The Study Team will follow the UAMS Requirements on Human Subjects Research 
Studies during the COVID-19 Outbreak ( https://tri.uams.edu/wp- 
content/uploads/2020/09/REVISED-Interim-UAMS-Requirements-for-Human-Subjects- 
Related-Research-Studies-during-COVID-19-Outbreak-051820.pdf ). All Team 
members recruiting patients will be screened daily and have documented PPE training 
located in the Training Manual for the iCOACH study. Appropriate PPE, handwashing, 
and distancing will be maintained to protect our potential participants and research team 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 15 
Date:  7/30/2021 
 
per protocol. Accordingly, research visits with participants will be conducted remotely 
when feasible. 
Data Handling and Recordkeeping 
The Principal Investigator will carefully monitor study procedures to protect the safety of 
research subjects, the quality of the data and the integrity of the study.  
A study Data Management Plan (DMP) will be developed. The Team will be trained on 
organizing, handling and storing data per the DMP. HIPAA Privacy Rules, confidentiality 
and protection of human subjects will be followed according to national standards (see 
Human Subjects section). 
Each subject is assigned a unique study code that will be used to track and manage all 
study data. A separate document containing the association between this unique study 
code and the subject’s identity will be created and stored separately from the analyses 
dataset in a locked cabinet in the Principal Investigator’s office and/or on a UAMS 
password-protected served accessible only by the Principal Investigator and study staff. 
The resulting de-identified dataset will be reviewed, descriptively analyzed, and 
statistically analyzed (where appropriate). Once the necessary data quality 
control/assurance measures have been addressed and the data analyzed, we plan to 
prepare the study for publication. 
At the conclusion of the study, the data and data key will be stored for at least 7 years 
and will share data using PCORI standards by storing the de-identified final analyzable 
data set appropriately, and by making the full data package available to other 
researchers after the research is completed. We will also share de-identified results with 
our local UAMS supports such as the UAMS Institute for Digital Health and Healthcare 
Innovation and the UAMS Translational Research Institute to inform their efforts for this 
and other projects. 
Data Analysis 
Data will be examined for completeness, outliers, and normality. Frequencies and 
percentages will be generated for screen failure reasons, for randomized participants, 
reasons for dropout and missing data. Descriptive statistics will be generated by 
intervention assignment and overall at 3 and 6 months. Baseline patient, caregiver, and 
system level characteristics will be compared according to intervention assignment to 
assess the success of the randomization; if there are imbalances, then consideration 
will be given to including the specific characteristic as a covariate to adjust intervention 
group comparisons. Continuous baseline variables will be compared using two-sample 
t-tests or nonparametric Wilcoxon rank sum & categorical variables will be compared
using chi-square or Fisher’s exact test.

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 16 
Date:  7/30/2021 
 
For the Primary Outcome (Self-Care of Heart Failure Index, management subscale, 
Aim 1), we plan to compare arms in terms of change from baseline using a repeated 
measures mixed model analysis of covariance (ANCOVA) with an interaction between 
time and adjusting for baseline subscale score and other covariates such as age, race, 
education, and rurality. To address correlation arising from repeated measurements on 
the same subject over time, a random subject effect will be included in the model. For 
the primary endpoint, we will compare intervention effect at 3 months and at 6 months 
using contrasts (model-based t-tests) at a significance level of 0.025 (Bonferroni 
adjustment of alpha level of 0.05 for 2 comparisons). We will also use multiple 
imputation methods to address missing data (see below). Since scores > 70 on the 
standardized scale have been used to indicate adequacy of self-care using a similar 
approach to the above, we will also analyze data as a binary endpoint in a repeated 
measures logistic model based on a generalized linear model framework. 
Secondary Outcomes, including other patient centered, caregiver, and health system 
outcomes, will similarly be modeled using an ANCOVA approach. Hospital admissions 
and adverse events will be analyzed as proportion with unplanned admissions in the 
next 6 months and event rates using logistic models and models based on Poisson 
calculations or Negative Binomial to handle potential over-dispersion issues, and 
mortality and time to first unplanned hospitalization will be compared using survival 
methods such as log-rank tests and Cox proportional hazards models. 
Evaluating heterogeneity of the treatment effect is a key consideration for Aim 2 since 
we want to identify which patients benefit most. The objective of the HTE analyses is 
evaluate whether the interventions produce differential benefits for subsets of 
participants. This will be investigated by including an interaction between baseline 
factors and intervention group (i.e., race x group) to the model above, and comparisons 
made using contrasts (model-based t-tests). The analytical approach taken is known as 
moderator analysis. Baseline factors include the demographic information as well as 
others measures, such as baseline self-care management score, age, race, rurality, 
gender, education, time since initial HF diagnosis, HF severity, depression, self-care 
confidence, etc. Factors with small subgroups (<20% of the sample size) will not be 
investigated. If the arm x time interaction is significant, we will include 3-way interactions 
to investigate if the intervention effect differs by subgroup at each time point. When 
there is not a significant interaction with time, we will investigate how the arm effect 
differs for subgroups averaged across time. The proposed measures will be considered 
moderators if it meets the eligibility and analytic criteria described by Wang & Ware 
(2013).37 Using the model mentioned above, we will also analyze data as a binary 
endpoint (adequacy of self-care >70 vs. <70) in a repeated measures logistic model; 
with this approach we can also give the probability of achieving adequacy of self-care 
for various subgroups in addition to odds ratios. 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 17 
Date:  7/30/2021 
 
Investigation of mediators (SCI-2) will be done by examining whether changes in self-care 
confidence, self-efficacy to manage symptoms, self-efficacy to manage
medications & treatment, or HF knowledge mediate the effect of the mHealth 
intervention on patient outcomes (e.g., self-care of HF index). We will use the method 
proposed by Hayes (2016)38 for evaluating mediation effects via a regression modeling 
approach which reflects the change scores in the mediators. Baseline measurement of 
the potential mediator and baseline outcome measure (e.g., self-care of HF index) will 
be included as covariates to provide a precise estimate of mediation effects. The test of 
mediation evaluating the indirect effect of the invention on outcome will be based on a 
product of coefficients approach. The modeling and testing for mediation as described 
by Hayes (2016) will be done for each mediator separately. As a sensitivity analysis for 
the mediation analyses, we plan to use a non-parametric bootstrap approach. Both the 
indirect effect of each mediator along with 95% bootstrap confidence intervals will be 
reported. 
Sensitivity analyses to determine the impact of key assumptions. In the event that 
continuous endpoints are skewed or key distributional assumptions are not met, we will 
investigate transformations (e.g., log) and compare findings based on parametric and 
non-parametric tests (e.g., Wilcoxon rank-sum test & robust regression techniques), as 
a sensitivity analysis to confirm findings. To address the impact of missing data, multiple 
imputation methods will be investigated. 
Plans to address missing data. Data collection procedures will be designed so that 
measures/instruments will not allow subjects to skip questions and assistance will be 
available to help complete the survey, if needed (e.g. may need to read to some 
participants if vision is problematic). We have built in travel resources to visit 
participants’ homes to complete a measurement interval (baseline,-3,-6 month), and/or 
can split this task within 2 days if participants become fatigued, as needed. See Data 
Collection Procedures. Sensitivity analyses will be conducted to investigate the impact 
of missing data (in the case of attrition) on estimates. The above analyses based on 
mixed models assume data are missing completely at random, but we will also use 
multiple imputation techniques to model missing data patterns, which is appropriate 
when data are not missing at random. These results will be reported as well in keeping 
with an intent-to-treat approach which uses data from all randomized participants, even 
those lost to follow-up. We anticipate that up to 10% of participants may die by six 
months. To address any differential dropout rates between interventions, the composite 
endpoint approach39 will be assessed similar to what was done for QOL outcomes in the 
ELITE study;40 one-sided tests are required for the approach so we will split our alpha 
accordingly assuming the alternative hypothesis is that the enhanced mHealth care 
model results in better outcomes. 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 18 
Date:  7/30/2021 
 
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations 
and University of Arkansas for Medical Sciences research policies and 
procedures. This protocol and any amendments will be submitted and approved by the 
UAMS Institutional Review Board (IRB) to conduct the study. 
Informed Consent & HIPAA Authorization 
The formal consent of each subject, using the IRB-approved consent form, will be 
obtained before that subject is submitted to any study procedure. All subjects for this 
study will be provided a consent form describing this study and providing sufficient 
information in language suitable for subjects to make an informed decision about their 
participation in this study. The person obtaining consent will thoroughly explain each 
element of the document and outline the risks and benefits, alternate treatment(s), and 
requirements of the study. 
The consent process will take place in a quiet and private room in-person or verbally by 
telephone, and subjects may take as much time as needed to make a decision about 
their participation. Participation privacy will be maintained and questions regarding 
participation will be answered. No coercion or undue influence will be used in the 
consent process. This consent form will be signed (written or Electonic consent) by the 
subjects if this is an in-person interaction, and by the person obtaining the consent. If 
this is a telephone consent, the Research Assistant will document “telephone consent” 
on the form. 
A copy of the signed, or telephone informed consent document and HIPAA 
authorization will be given, emailed, or mailed to the participant, and the 
informed consent process will be documented in the research record. 
In light of the COVID-19 pandemic, we may need to perform informed consent and 
obtain HIPAA authorization on some subjects verbally, using the telephone. For 
example, because of COVID-19, caregivers are most often not in the patient’s hospital 
room and may only be allowed to pick up the patient outside of the building, we would 
not have a in person interaction with the caregiver at all. Additionally, if the HF patient is 
recommended to quarantine, although he/she would be in the hospital, we may need to 
contact the participant by telephone to limit the in-person interaction time. 
The verbal consent & HIPAA authorization of subjects, using the IRB-approved 
telephone script, will be obtained before the subject is allowed to participate in any 
study procedure. The person obtaining consent and HIPAA authorization will thoroughly 
explain each element of the documents, especially outlining the risks and benefits, 
alternate treatment(s), and requirements of the study. Subject consent and HIPAA 

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 19 
Date:  7/30/2021 
 
authorization will be documented on the informed consent process note in the subject 
research file. 
The research team member obtaining consent and HIPAA authorization will document 
the consents by indicating a proxy signage of the “telephone consent” of “participant 
name” by “research team member’s name”, with “time and date”. A copy of these forms 
will be mailed to the participant. (This alternative to an in-person consent will also limit 
contact with potentially contaminated documents and reduce burden on patient 
participant and caregiver.) 
Dissemination of Data 
Results of this study may be used for presentations, posters, or publications. The 
publications will not contain any identifiable information that could be linked to a 
participant. The study will be listed on clinicaltrials.gov in accordance with (journal or 
FDA) requirements. The final, anonymized dataset will be made publicly available 
through PCORI. 
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Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 20 
Date:  7/30/2021 
 
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Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 21 
Date:  7/30/2021 
 
18. Kitsiou S, Pare G, Jaana M. Effects of home telemonitoring interventions on patients
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Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 22 
Date:  7/30/2021 
 
30. Jones L, Grech C. The patient experience of remote telemonitoring for heart failure
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Comparison of the Saint Louis University mental status examination and the mini- 
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pilot study. Am J Geriatr Psychiatry. 14(11):900-10.

Study Title: 
Innovative Care of Older Adults with Chronic Heart Failure (I-COACH): A 
Comparative Effectiveness Clinical Trial 
Judith Weber, PhD, RD 
University of Arkansas for Medical Sciences 
PCORI Grant 
PI (researcher): 
Institution: 
Funding: 
Version #: 7 
IRB#260092 
Page 23 
Date:  7/30/2021 
 
Appendices