Telehealth Self-Management Program in Older Adults Living With Heart Failure in Health Disparity Communities
Phase: NA
Conditions: Chronic Heart Failure
Sponsor: Northwell Health

 
Version: 3/25/2016 
    
 
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IRB PROTOCOL: Telehealth Self-Management Program in Older Adults Living with Heart 
Failure in Communities with Health Disparities 
 
 
SPONSOR: Patient Centered Outcomes Research Institute (PCORI) 
 
 
 
PRINCIPAL INVESTIGATOR:  
Renee Pekmezaris, PhD,  
VP, Health Services Research Division,  
Department of Population Health,  
175 Community Drive, Great Neck, NY 11030, USA 
Email: rpekmeza@nshs.edu 
Phone: 516-465-3161 
Fax: 516-465-2699 
 
  
 
 
CO-INVESTIGATORS (in alphabetical order):  
Deborah Ahern, NP, Lorinda Bauer, RN MBA, Stacy Castillo, RN Paola DiMarzio PhD, MPH, 
Martin Lesser PhD, Amgad Makaryus, MD, Christian Nouryan, MA, Stephanie Moharan, RN, 
Kathleen Pecinka, RN, MSN, Rebecca Schwartz, PhD, and Tonya Taylor PhD. 
 
 
 
SITE: Nassau University Medical Center (NUMC), 2201 Hempstead Turnpike, East Meadow, 
NY 11554, USA 
 
Contact: Paola Di Marzio, PhD, MPH, (516) 465-3167 
 
 
 
 
 
 

   
 
 
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INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND SIGNIFICANCE 
 
 
Disparities in cardiovascular disease (CVD) have received particular focus, as CVD is a major 
contributor to differences in morbidity and mortality between blacks and whites.1-5 Blacks are 
more likely than whites to develop CVD and die at earlier ages from heart failure, stroke, and 
myocardial infarction.6,7 The incidence of chronic heart failure (CHF) is equally frequent in men 
and women.8 The relative incidence of CHF is 50% higher in African Americans compared to the 
general population. Moreover, the disease occurs at an earlier age, resulting in more advanced 
disease severity.9 Likewise, Hispanics with CHF are younger and die earlier than non Hispanic 
whites. The reasons for this greater disease burden of CHF in African Americans and Hispanics 
are complex, resulting from the interaction of factors such as hypertension, diabetes, obesity, 
reduced health care access, socioeconomics and cultural factors.6,10,11 Given the larger burden 
of CHF in these populations and the unfavorable disease outcomes, a tailored and more 
focused management of this clinical condition is warranted. 
 
CHF is the most frequent diagnosis in hospitalized patients over 65, and is a leading cause of 
disability and death.12,13 CHF is a progressive chronic disease characterized by a variety of CVD 
problems leading to cardiac dysfunction and eventually to the typical CHF symptoms such as 
dyspnea, fatigue, and congestion.9 CHF is characterized by recurrent periods of clinical 
exacerbation that often lead to frequent  physician office visits, high rates of emergency room 
(ER) and inpatient hospital utilization. Unfortunately, most community-dwelling patients living 
with heart failure receive exacerbation-focused care without a comprehensive chronic 
management program. At present, neither patients nor their caregivers have the knowledge and 
the skills to participate in managing this disease. Usual care results in repetitive, inefficient and 
costly cycles of hospitalization, rehabilitation and home care after exacerbation followed by no 
monitoring, with the exception of the occasional physician office visit. This lack of management 
leads to poor health outcomes, including decreased quality of life, decreased functional status 
and increased health care costs.  
 
The use of telehealth is a promising approach to optimizing outcomes in the treatment of CHF 
for patients living in the community. As exacerbations of CHF are common in the disease 
progression, the use of telehealth to monitor physiologic indicators, such as weight, heart rate, 
lung sounds, and blood pressure enables improved management through timely treatment 
adjustments. Without leaving their homes, patients can upload vital signs and be monitored by 
clinicians through telehealth visits using voice and video equipment combined with peripheral 
medical technology. Telehealth self management (TSM) can provide the patient with self-
management tools to facilitate follow-up care.14 Interactive health information technology not 
only provides health tools and health information that is patient centered but also engages 
patients and promotes their active participation in improving their health and their quality of life 
(QoL).1516,17  
 
 
Although many telehealth trials in community-dwelling seniors have been published, there is 
limited literature on the use of telehealth in underserved populations. The few telehealth 
studies conducted in disparity populations have focused primarily on diabetes and blood 
pressure management. Given the great discrepancy in prevalence rates of CVD disease and its 
manifestations between whites and ethnic minorities, coupled with the disparities in access to 
innovative and effective treatments between upper/middle and lower socioeconomic classes, it 

   
 
 
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is imperative that researchers and clinicians bring effective interventions to these at-risk 
populations. 
 
The previous work of our research team includes a two-year randomized trial, a two-year 
matched control study, and a three-year randomized trial (currently underway). We have shown 
that TSM can create cost savings and shorter lengths of stay for those hospitalized. The present 
study proposes to test this technology with an underserved population to determine whether our 
previous results are generalizable.26 
 
 
OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
Research Question:  Can we narrow health disparities through TSM by providing the proposed 
disparity population with skills to monitor their health status daily and weekly access to a health 
practitioner through a scheduled telehealth video visit? We hypothesize that TSM patients will 
have significantly better outcomes: greater QoL and lower hospital utilization over 3 months 
than those receiving usual care. 
 
In this study, we will apply appropriate and rigorous research methods to: a) assess patient 
acceptance and usability using a mixed methods approach; and b) directly compare TSM to 
standard of care in a health disparity population.  
 
Aim 1: we will conduct a process evaluation to assess telehealth acceptance and usability 
among low-income, largely minority seniors living with CHF NYHA class 1-3.  
 
We will use a mixed methods approach to look at indicators of usability, including qualitative 
measures, such as: 1) focus group feedback from key community stakeholders, including 
patients and caregivers, and quantitative measures, such as 1) rate of study participation 
acceptance; 2) self-monitoring behavior (as measured by vital sign uploads); 3) visit 
participation; 4) patient satisfaction; and 5) ease of use of measures.  
 
Aim 2:, we will conduct the first randomized controlled trial (RCT) to telemonitor minority 
community-dwelling patients with CHF (NYHA class1-3) for 3 months after hospital discharge 
for CHF. We will compare hospital and emergency room utilization, as well as QoL, between 
TSM and standard of care groups.  
 
According to the NYHA classification system, patients experience increased limitations in 
physical activity, such as fatigue, palpitation and angina pain, from mild in class 1 to extreme in 
class 4. Patients in class 4 experience these symptoms even at rest, and are usually bed-
bound. We specifically excluded seniors with heart failure NYHA class 4 because they are 
primarily bed-bound and highly unlikely to be able to participate in the tasks required of the 
intervention.  
 
Specifically, after hospitalization for a CHF exacerbation at NUMC, patients will be approached 
by the heart failure clinic nurse to assess interest in participation. The study will be described in 
detail, and patients will be assured of confidentiality. Once patients give permission, the clinic 
nurse will personally introduce the patient to the research nurse, and reiterate their willingness 
to participate, the formal consent process will occur. Patients will be randomized once they have 
given consent to participate in the study. 
 

   
 
 
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EXPERIMENTAL DESIGN 
Aim 1: we will conduct a process evaluation to assess telehealth acceptance and usability 
among low-income, largely minority seniors living with CHF NYHA class 1-3.  
 
We will assess usability of an existing Heart Failure telehealth intervention and will adapt the 
intervention to facilitate acceptability and feasibility in a population of low-income ethnic minority 
patients. Usability will be assessed throughout the study period through the examination of 
usability indicators presented temporally below.  
 
1a. Pre-study usability (stakeholder perspective): Qualitative methodology (i.e., focus 
groups) will be used to gather information regarding intervention adaptation to ensure patient 
acceptability and feasibility from the community advisory board (CAB) which will include patients 
and key stakeholders.  The CAB will consist of individual Heart Failure patients and caregivers 
in the community and individuals within the community with whom the PI has already forged 
relationships in addition to members of the NUMC advisory board. This CAB is demographically 
and geographically representative of the patient population at NUMC. CAB members will be 
compensated $50 for attendance at each meeting. Two focus group discussions will be 
conducted with CAB members in a confidential meeting room at NUMC. Each one will last 
approximately 2 hours and will be audiotaped using two digital voice recorders (one for backup 
in case of technical failure) and professionally transcribed. CAB members will be presented with 
the intervention (in English and Spanish) including its core components (non-adjustable 
components) as well as its key characteristics that can potentially be adjusted to formulate the 
initial implementation of the intervention. The second focus group will occur immediately after 
adaptation (but prior to intervention implementation) to ensure that we have effectively 
incorporated all of the CAB feedback. We have already anticipated and addressed some 
adaptation issues (e.g., having the intervention technology available in Spanish and having a 
study nurse who is fluent in Spanish; using air cards, as some patients are not going to have 
landlines or broadband).  The focus group discussion will be facilitated by Drs. Taylor and 
Schwartz and the discussion will be guided by predetermined topics outlined in the attached 
interview guide (see Appendix 1). To ensure that the patient representatives in the CAB will 
have ample space and time to express their ideas and thoughts, Drs. Schwartz and Taylor will 
prioritize their contributions above the medical and professional stakeholders.  Structural coding 
will be used to mark responses to topical questions in the interview guide.20 Following a review 
of the a priori topics, Drs. Schwartz and Taylor will use grounded theory to develop a codebook 
to categorize the data and identify salient themes and relationships.21,22 Using thematic analysis, 
each transcript will then be independently coded by Drs. Schwartz and Taylor using NVivo 23 
software. The main themes that emerge will specify any necessary adaptation that the CAB 
believes should occur.  
 
1b. Patient Usability (patient perspective): We will also conduct a focus group with the initial 
10 patients enrolled in the intervention arm of the study to obtain user feedback regarding any 
barriers to implementation or usability suggestions to further adapt the intervention if necessary 
before additional participants are enrolled. The qualitative methods detailed above will be 
employed. The patient focus group will take approximately two hours and will be conducted in a 
confidential conference room at NUMC. Patient participants will be compensated $50 for their 
participation. The discussion guide for the patient focus group will be developed by the Drs. 
Schwartz and Taylor with input from the CAB (see Appendix 2). Discussion topics include (but 
are not limited to) the following: 1) patients’ perceptions of the ease of the study implementation 
(using the equipment, uploading) 2) patients’ perceptions of usefulness of the intervention; 3) 

   
 
 
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patients’ input on barriers/challenges to intervention implementation; and 4) suggestions for 
improvements and/or adjustments that should be made. Data will be coded and analyzed using 
NVivo (see above) to identify the barriers and challenges that need to be addressed as study 
implementation continues in order to ensure a high level of usability. 
 
Patient Utilization: This phase of intervention development will also involve an ongoing 
process evaluation of usability using quantitative methodology. Again, this is so that 
adjustments can be made, as necessary, as the TSM intervention is implemented.  
 
We will operationalize usability using the following measures:  
1) Rate of acceptability 
2) Rate of installation acceptance 
3) Upload compliance 
4) Total number of visits 
5) Patient satisfaction 
 
Aim 2: we propose to conduct the first randomized controlled trial to telemonitor minority 
community-dwelling patients with CHF (NYHA class1-3) for 3 months after hospital discharge or 
CHF. We will compare hospital and emergency room utilization, as well as QoL, between TSM 
and standard of care groups.  
 
This is a prospective randomized controlled trial of 104 community-dwelling patients from 
disparity communities living with CHF 18 years and older. 
 
In this study, patients will be randomized either to TSM or to standard of care once they have 
given consent to participate to directly compare TSM to standard of care in a health disparity 
population.  
 
Patients with CHF will be subjected to either TSM or 
standard of care as follow: 
 
TSM Intervention. TSM is defined as a weekly visit and 
self-monitoring of daily vital signs utilizing a Subject 
Monitor which connects from the subject’s residence, via a 
standard telephone line to the provider station (American 
TeleCare® Provider Station available in both English and 
Spanish language).  
 
TSM has two components:  
1) a daily vital signs self-monitoring component 
(client-side operation), which requires the subject to 
monitor and transmit standard key indicators of possible 
condition exacerbation to the server including blood 
pressure, oxygen saturation, weight, and pulse/heart rate, 
and  
2) a weekly telehealth visit, wherein patients are 
instructed to attend a regularly scheduled video visit with 
the practitioner (real time), and queried regarding their behavior and condition during that week.  
 

   
 
 
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Figure 1. Daily vital signs generated for the patient.
TSM Intervention Component 1: daily vital signs. Daily Vital Signs (Entered, Transmitted and 
Reviewed Daily). Patients will be trained by the practitioner how to utilize the peripherals that 
attach to the equipment (blood pressure cuff, pulse oximeter, weight scale and stethoscope) 
and will be instructed how to enter key indicators into their subject station on a daily basis. 
During these daily transmissions, which take about 10 minutes, patients will sit in front of the 
patient station and attach each peripheral so that automatic transmissions of each key indicator 
will be automatically sent and stored on the server database. Key indicators include: blood 
pressure, oxygen saturation rate, weight, and pulse/heart rate. The transmittal time is scheduled 
and a reminder alarm alerts the patient at the patient/practitioner-determined time of day.  The 
patient, hearing the alarm, answers interview questions, and transmits vital signs. Patients will 
be instructed to call their practitioner if their readings are out of range to discuss next steps. The 
range is established as per physician guidelines. The telehealth practitioner will review 
transmitted indicators within 24 hours post-transmission, and within 72 hours on weekends. If 
values for key indicators are outside the normal range, then the subject/significant other may be: 
a) reassured that readings are benign in nature; b) instructed to conduct a telehealth visit; c) 
instructed to call their physician or, for urgent matters, the practitioner may call the physician 
him/herself. Figure 2 presents typical vital signs feedback (blood pressure, oxygen saturation, 
pulse, and weight) generated for the patient, allowing them to easily identify out-of-range values. 
For patients whose primary language is Spanish, the modules will be provided in Spanish.  
TSM Intervention Component 2: Telehealth Visit. Once a week, patients will be instructed to 
connect to the patient station for a weekly scheduled video telehealth (TSM) visit with the 
telehealth nurse. The video visit allows the subject and the provider to view one another and 
listen to the patient’s heart and lung sounds. During the telehealth video visit, the patient and 
provider will discuss signs and symptoms of CHF and the practitioner will review the weekly 
uploads. Table 1 presents the indicators that will be obtained through the weekly visit for TSM 
and control patients in detail. For example, if the patient reports edema, further questioning will 
clarify the location and degree of the swelling and a treatment plan will be initiated. The 

   
 
 
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telehealth nurse will also ask the patient to show the area where edema is occurring on the 
monitor using the video camera on the telehealth machine. In addition, the provider will initiate a 
discussion regarding the importance of fluid and sodium management (see Table 2 for patient 
education management). In addition to these two components, QoL will be assessed at 
enrollment (immediately post-consent) and three months after enrollment utilizing the Minnesota 
Living with Heart Failure Questionnaire (QOL). Patients will also be assessed for symptoms of 
depression and generalized anxiety disorder using the PHQ4 questionnaire19 (Month 1; see 
appendix 5). 
 
Standard of care (Control Group). Patients in the control group will receive usual care at 
NUMC Heart Failure clinic (primary and cardiac care as reimbursed by Medicare or sliding 
scale/uncompensated care). As noted above, usual care patients will be contacted on a weekly 
basis in order to maintain comparable frequency of contact. As detailed in Table 1, patients will 
be queried regarding ER, hospital utilization (primary outcome variables). They will also be 
assessed, at months 1 and 3, for QoL and for symptoms of depression and generalized anxiety 
disorder using the PHQ4 questionnaire19 (Baseline; see appendix 5). Finally, at the end of the 
study (month 3), they will be asked if their home care agency supplied any type of telehealth 
intervention using the attached survey (Control group exit survey).  
 
SCHEDULE OF EVENTS: The table below delineates the expected schedule of events. 
Major milestones include: patient recruitment, CAB meetings, CAB focus groups, patient 
focus group, and data analysis. 
Month 
1
M2
M3
M4
M5
M6
M7
M8
M10
M11
M12
M13
M14
M15
M16
M17
M18
M19
M20
M21
M22
M23
M24
M25
M26
M27
M28
M29
M30
M31
M32
M33
TSM
1
1
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
Control
1
1
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
Total 
enrolled
2
2
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
CAB
CAB
CAB
CAB
CAB
Data analysis 
M9
104 Subjects Randomized to TSM (n=52), and Usual Care (n=52) - Following Subjects for 3 Months 
3 MONTHS
FOLLOW 
UP 
3 MONTHS
FOLLOW 
UP 
3 MONTHS
FOLLOW 
UP 
FIRST CAB FOCUS 
GROUP
2nd CAB FOCUS GROUP 
AFTER INTVN 
PATIENT FOCUS GROUP 
 
 
INCLUSION AND EXCLUSION CRITERIA Subject Selection 
 
Inclusion Criteria for CHF Patients and CHF patient focus group: 1) CHF patients about to be 
discharged from NUMC or within a week from discharge; 2) 18 years and older; 3) NYHA class 
of 1-3; 4) primary language of Spanish or English; 5) access to a phone (land line or cell); 6) 
Folstein MMSE score of 21 or higher; 7) anyone who self identifies as Black/Latino/multiracial 
(must include black or Hispanic). We will also conduct a focus group with the initial 10 patients 
enrolled in the intervention arm of the study to obtain user feedback regarding any barriers to 
implementation or usability suggestions to further adapt the intervention if necessary before 
additional participants are enrolled.                                                                                                               
 

   
 
 
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Inclusion criteria for CAB focus groups: The CAB will consist of CHF patients (and caregivers in 
the community and stakeholders (individuals) within the community with whom the PI has 
already forged relationships, in addition to members of the NUMC advisory board; Inclusion 
criteria for patients participating the CAB focus group are: patients with CHF, NYHA class 1-3 
and at least 18 years old.   No inclusion or exclusion criteria for the other member of the CAB 
group, such as stakeholders and caregivers.      
                                                                                                                                                                                 
Exclusion Criteria for CHF patients and patient focus group: 1) seniors with heart failure NYHA 
class 4 (because they are primarily bed-bound and highly unlikely to be able to participate in the 
tasks required for the intervention); 2) Anyone under age 18; 3) Anyone with no access to a 
phone; 4) Anyone with a primary language that is not English or Spanish; 5) Anyone with a 
Folstein MMSE score under 21 (indicative of cognitive impairment); 6) Anyone who declines 
consent; 7) Anyone who does not identify as Black/Latino/multiracial; 8) Patients who have 
chosen a home care agency that provides telehealth monitoring.  Therefore, patients will be 
contacted and enrolled only after they have chosen their home care agency.    
 
No exclusion criteria for members of the CAB group. 
 
RECRUITMENT PROCEDURES  
Individuals participating in the focus groups and CAB will consist of patients with CHF, 
caregivers and patient’s stakeholders in the community with whom the PI has already forged 
relationships in addition to members of the NUMC advisory board. Drs. Schwartz and Taylor will 
review the consent form with these individuals and consent will be obtained if the subject is 
willing to be part of the study.  
 
When discharge from NUMC is imminent, Deborah Ahern, NP, the Director of the NUMC Heart 
Failure Clinic, will review the study with the patients and consent will be obtained if the subject is 
willing to be part of the study.  The study will be described in detail, and patients will be assured 
of confidentiality. Once patients give permission (in writing) to discuss the study, the clinic nurse 
will personally introduce the patient to the bi-lingual research nurse (TBA), and reiterate their 
willingness to participate, the formal consent process will occur. The research nurse will discuss 
the study with the patient, including a discussion of the overall goals of the study, the study 
design, the study time frame (3 months), and the randomization procedures. The nurse will also 
gather basic information regarding inclusion and exclusion criteria (ex., NYHA class). If the 
patient meets the inclusion criteria, the nurse will read the consent form aloud, in the patient’s 
primary language, which contains information regarding confidentiality of protected health 
information, the de-identification of data, risks and benefits of study participation and a 
description of compensation for participation. The nurse will explain that the information 
collected regarding daily health could be shared with the patient’s physician when necessary, 
but is completely de-identified for research purposes and will not be shared with anyone else at 
any time. The consent form will also underscore that the patient can withdraw from the study at 
any time with no consequences. The nurse will also make sure that the patient understands that 
he/she will be randomized to either the telehealth self management (TSM) intervention or a 
control group which is standard of care. However, the nurse will explain to the patient that 
enrollment for the telehealth arm of the study has ended and he/she will be enrolled in the 
standard of care arm. If the patient agrees to participate, she/he will be asked to sign an 
informed consent form. The informed consent will comply with all HIPAA and IRB requirements. 
 We will conduct a block randomization technique to ensure equivalency of gender and Heart 
Class 3 patients across the two groups. Patients will be randomized by the Feinstein 

   
 
 
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Biostatistics Unit, as utilized in our previous studies. CAB members and patients who participate 
in the focus groups will be compensated $50. Patients in both arms of the RCT will receive $100 
for participation.  
 
INFORMED CONSENT 
1) Informed consent for the RCT: Deborah Ahern, NP, Director of the NUMC Heart Failure 
Center, and Stacy Castillo RN, will review the study with the patient and consent will be 
obtained if the subject is willing to be part of the study. 
2) Informed consent for the CAB focus groups: two members of the study team, Dr. 
Rebecca Schwartz and Dr. Tonya Taylor will review the study with the participants and 
consent will be obtained if the participant is willing to be part of the study.  If employees 
are enrolled, they will not be consented by an investigator with supervisory authority over 
the employee.  
3) informed consent for the patient focus groups: two members of the study team, Dr. 
Rebecca Schwartz and Dr. Tonya Taylor will review the study with the patient and 
consent will be obtained if the patient is willing to be part of the study 
 
 
DISCOMFORTS AND RISKS 
The risks of participating in the focus groups are minimal in that the topics will involve CAB 
members’ and patients’ opinions of the TSM technology as well as study implementation, 
methodology and dissemination. Efforts will be made by focus group facilitators to ensure that 
all focus group participants are given time to express any opinions. Focus groups are audio-
recorded which may cause slight discomfort among participants, but study team members will 
reiterate that qualitative study data will be kept confidential and will not impact patient care in 
any way.  
 
The risks of participating in the TSM RCT portion of the study are no greater that those 
encountered by community-dwelling patients living with CHF. In fact, the risk of participating in 
the intervention arm may in fact be lower, since there is a nurse in frequent contact with the 
subject and monitoring vital signs of the subject. For the control group, the risks are identical to 
those encountered by community-dwelling patients living with CHF. The medications and 
interventions that a physician would provide to his/her patients are not investigational, and are 
considered standard of care. 
 
POTENTIAL BENEFITS 
Knowledge gained from this program will further our understanding of the use of telehealth self-
management programs as effective vehicles in the management of CHF for low-income minority 
community-dwelling seniors living.   
 
Participants in the study, particularly those receiving TSM, may benefit from both knowledge 
and comfort gained in learning to self-monitor, as well as improved quality of life (QoL), partially 
as a result of decreased hospitalizations.  
Such outcomes may lead to prioritizing this TSM intervention as a valuable chronic care 
management tool for community-dwelling seniors: those patients at highest risk for 
exacerbation. In addition, if TSM proves to be successful, it can set the groundwork for the 
management of other chronic care conditions (e.g., COPD). Considering that there are few risks 
to the participants, and information will be kept confidential, the advantages will surely 
overcome the risks. 

   
 
 
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DISCONTINUATION OF STUDY/SUBJECT WITHDRAWAL 
The patients and CAB members may withdraw from the study at any time after giving consent. 
 
The study may be discontinued at any time. Any actions that may follow such discontinuation of 
the study will have no impact upon patient care. 
 
 
 
ADVERSE EVENTS  
Any adverse events, unanticipated problems and protocol deviations will be reported to the IRB 
as per NSLIJ policy in addition to PCORI, the funding agency. If, during the course of the 
telehealth monitoring, the telehealth nurse becomes aware that the values for key indicators are 
outside the normal range, then the subject/significant other may be: a) reassured that readings 
are benign in nature; b) instructed to conduct a telehealth visit; c) instructed to call their 
physician or, for urgent matters, the practitioner may call the physician him/herself. 
 
 
DATA SAFETY MONITORING 
Information required from the subjects in this study, whether via subject interview or 
computerized transmission, is routine data that would normally be collected in a routine office 
visit with a physician or nurse. 
 
Deborah Ahern, NP, will monitor data and safety, with emphasis on data integrity and patient 
safety concerns including:  review of adverse events, recommendations concerning continuation 
or conclusion of the study, protection of the confidentiality of the data and the results of 
monitoring, review of data and study quality.  Monitoring will occur once a month. 
 
 
Any adverse events, unanticipated problems and protocol deviations will be reported to the IRB 
by the PI as per NSLIJ policy.  
 
De-identified quantitative data will be submitted to the Biostatistics Department and the 
Department of Population Health for analysis. The data collection tool will be located in the 
health system server in a password protected file. 
 
CRITERIA FOR EVALUATING RESPONSE/STATISTICAL ANALYSIS  
 
Aim 1: we will conduct a process evaluation to assess telehealth acceptance and 
usability among low-income, largely minority seniors living with CHF NYHA class 1-3.  
This phase of intervention development will involve focus groups with CAB members and 
patients and it will also involve an ongoing process evaluation of usability using quantitative 
methodology. Again, this is so that adjustments can be made, as necessary, as the TSM 
intervention is implemented.  
 
The focus group methodology relies on a grounded theory approach and uses an analytic 
strategy that has been well documented in the qualitative literature. 21,22 As described above, 
our CAB focus groups will be comprised of key stakeholders in the community of the target 
patient population including patients themselves whose thoughts and opinions will be prioritized 
during the two CAB focus groups. Further, our patient focus group will consist of patients who 

   
 
 
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demographically match the patient population and will be key sources of information on the 
usability of the TSM technology. The representativeness of the focus group participants serves 
to reduce bias in terms of relevance and acceptability of ethnic minority CHF patients living in 
low-income communities. The transcription of the qualitative data will be conducted by a 
transcriber who is unaware of the study aims thereby reducing any researcher bias. The 
qualitative coding will be initially conducted independently by Drs. Taylor and Schwartz and then 
through discussion based on grounded theory, the two researchers will work toward consensus. 
Employment of this strategy also reduces the likelihood of researcher bias.    
 
We will also evaluate usability using the following quantitative measures:  
 
Rate of acceptability. In order to determine the rate of acceptability of TSM in the discharge 
environment, we will determine, among those who DO NOT consent to be part of the study, the 
proportion who state that their reason for non-consent is related to the proposed technology vs 
those who simply do not want to be part of a clinical study that includes randomization and/or 
longitudinal follow up. This will allow us to compute the “acceptability rate” (as opposed to 
“acceptance rate” below).  
 
Rate of installation acceptance: Among those who consent and are randomized to the TSM 
arm, the rate of “acceptance” will be the proportion of patients who then go on to accept 
installation of the equipment into their homes. 
 
Upload compliance: We are arbitrarily defining three levels of compliance: High, moderate and 
minimal.  “Minimal” compliance is defined as at least one upload per week for 6 out of the 12 
weeks. “Moderate” compliance is defined as at least one upload per week for 9 out of the 12 
weeks, and “High” compliance is defined as at least three uploads per week for 9 out of the 12 
weeks. A secondary compliance measure will be the number of uploads over the 90 day period. 
= u/d. (maximum number of possible uploads = 90). All of these measures will be appropriately 
prorated for patients who die, or are hospitalized during the study, and are therefore not subject 
to uploading requirement during those times. With a sample size of 52 patients, the rates of 
compliance can be estimated to, at worst, +- 13.9%, with a 95% CI.  
 
Total number of visits: We will compute the proportion of 12 scheduled visits that are kept.  
Therefore, if a patient is being followed for w weeks, there should be w scheduled visits. If the 
number scheduled visits that are kept is denoted by v, then the proportion of scheduled visits 
kept = v/w. Visit participation rates will be averaged across patients, and the mean rate will be 
computed, along with 95% confidence intervals. There is a maximum of 12 possible telehealth 
visits over the 3 month study period.  
 
Patient satisfaction: We will measure patient perceptions of usability using a slightly modified 
version of the Telemedicine Satisfaction and Usefulness Questionnaire (Appendix 3). This 22-
item questionnaire, which utilizes a 5 point Likert scale, will elicit a total sum score of 
satisfaction/usability that will then be dichotomized into satisfied vs. not satisfied based on 
previous literature.  
Sample size considerations: We will randomize 116 patients as they are discharged from the 
hospital (58 per arm) in order to yield a maximum of 52 patients in the TSM arm of the study 
over a two year period.  

   
 
 
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These scores will be assessed using mean scores, percentages and histograms.25  For 
satisfaction rates of 50%, 75% and 90%, with a sample size of 52, the corresponding 95% 
confidence intervals will have precision of +/- 13.9%, 12.7%, and 8.3%, .  
 
Aim 2: we will measure inpatient utilization, emergency room utilization and QoL of 
patients receiving telehealth technology vs. standard of care patients.  
 
2a. Measures of Inpatient Utilization. Inpatient utilization will be measured in three ways, 
including: 2a.1) whether an individual subject had at least one inpatient hospitalization over the 
3 month period; 2a.2) the number of hospitalizations experienced by an individual subject over 
the 3 month period; and 2a.3) cumulative length of stay (LOS) (inpatient days) experienced by 
an individual subject over the 3 month period (i.e., for multiple hospitalizations, the sum of all 
LOS’s will be computed as the cumulative LOS). Cumulative LOS will be analyzed in two ways: 
intention to treat (ITT) analysis, and for only those hospitalized. The ITT analysis will include all 
patients, regardless of hospitalization history, to address the bigger public health issue: does 
TSM have an impact on LOS overall? A secondary analysis will look at LOS only for those who 
experienced a hospitalization. Finally, after ITT analysis, secondary analyses will include 
covariate adjustments for possible confounders. 
 
Statistical Methods: Inpatient Utilization. For outcome 2a.1, the proportions of patients in 
each group who were hospitalized will be compared using the standard Chi-square or Fisher’s 
exact test. Associated 95% confidence intervals for these proportions and their differences will 
be computed using exact methods. For outcome 2a.2, the number of hospitalizations will be 
compared using Poisson regression (SAS PROC GENMOD). It is likely that, due to excess 
zeros (i.e., zero inflation), methods for overdispersed Poisson will be required.  Another 
approach  for both outcomes 2a.2 and 2a.3 will be to use Lachenbruch’s two stage procedure 
for zero-inflated data.30 For these primary ITT analyses, no adjustments will be made for any 
covariates. 
 
Sample size considerations: We expect to enroll 52 patients in the TSM group which will yield 
the necessary statistical power.  
 
2b. Measures of ER Utilization, defined as: 2b.1) whether or not an individual subject had at 
least one ER visit over the 3 month period; and 2b.2) the number of ER visits experienced by an 
individual subject over the 3 month period. Covariate adjustments will be made for potential 
confounders. 
 
Statistical Methods: ER Utilization: The statistical methods for analyzing ER utilization 
outcomes will be similar to those presented for inpatient utilization. Specifically, for outcome 
2b.1, the proportions of patients in each group who utilized the ER will be compared using the 
standard Chi-square or Fisher’s exact test. Associated 95% confidence intervals for these 
proportions and their differences will be computed using exact methods. For outcome 2b.2, 
(overdispersed) Poisson regression will be used. For outcome 2b.2,  Lachenbruch’s two stage 
procedure for zero-inflated data will also be considered.25   
 
Sample Size Considerations. The sample size and power considerations identified for 
outcomes 2a.1 and 2a.2 are virtually identical for ER utlization.  
 

   
 
 
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2c. Quality of Life assessment:  We will use the Minnesota Living with Heart Failure 
Questionnaire27 (Appendix 4) to assess patient QoL (QoL). While HF will continue to impact the 
lives of these patients, it is reasonable to believe that proper disease management via 
telehealth will improve QoL due to earlier exacerbation detection and lowered hospital 
utilization. We will compare questionnaire results between patients receiving TSM and usual 
care patients. Measures of QoL are defined as the 3 month QoL score minus the 1 month QOL 
score, where a positive score indicates a worsening of QoL . 
 
Statistical Methods. A two-sample z-test will be used to compare changes in QoL between 
groups.  
 
Sample size and power considerations. we expect to enroll 52 patients in each group, a 2-
sample z test (80% power) to detect an effect size of 0.39 or greater, which is considered 
“small” to “medium”.28  
 
Secondary Analyses: Adjusting for Confounders: Potential confounders will be demographic 
(age, gender, race, ethnicity, primary language spoken, insurance status (insured vs not-
insured), education (high school graduate vs. non-graduate), major co-morbidities (e.g., 
diabetes Y/N) and functional variables (e.g., heart class, depression symptoms, anxiety 
symptoms, and caregiver support). All of these measures will be assessed at baseline only. We 
will use the PHQ4 19(Appendix 5) to assess symptoms of depression and generalized anxiety 
disorder as both of these are factors known to have direct impact on cardiovascular outcomes.29 
This is a brief measure (with limited potential participant burden) that has been validated and 
widely used with heart failure patients.30,31 It has also been translated into Spanish.32,33 We will 
also use a brief measure of caregiver support that assesses assistance with heart failure 
medical care. The stem question asks if there is someone in participants’ lives who helps with 
heart failure medical care and if answered in the affirmative, participants then indicate their 
relationship with that person and whether the person lives in the home (Appendix 6). To this 
end, multiple logistic regression will be used where the outcome variable is hospitalization 
(yes/no) and the predictor variables are treatment group (telehealth vs. control) on the 
aforementioned covariates. For number of hospitalizations and length of stay (LOS), analysis of 
covariance (ANCOVA) will be used if the required distributional assumptions can be met. If not, 
extension of Lachenbruch’s procedure using logistic regression and analysis of variance will be 
used.  
 
CONFIDENTIALITY 
Confidentiality will be protected by assigning to each subject a research data a unique identifier 
known only to IRB approved personnel.  
 
Storing Documents in Hard Copy 
Any documents that contain PHI (e.g., consent forms, link between the ID to subjects’ 
identifiers) will be stored in a locked cabinet within the office of the principal investigator, 
separately from any de-identified research documents.  IRB approved personnel will be the only 
individuals with access to any research documents containing PHI. 
 
Storing Documents Electronically 
Any documents that contain PHI (e.g., link between the ID to subjects’ identifiers) will be stored 
in a password protected computer document/database that will be stored on the NSLIJ network 
server, separately from the other de-identified research data files. IRB approved personnel will 

   
 
 
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be the only individuals with access to any research documents containing PHI. De-identified 
data files will be stored on a password protected computer network. 
 
Storing Documents on Portable Electronic Devices 
No PHI will be stored on any Portable Electronic Devices (e.g., laptops, tablets, flash drives, 
etc.). A laptop computer will be used to collect some anonymous research data. The data will 
then be transferred to the NSLIJ server using an encrypted flash drive. This de-identified data 
will be will be removed  from the flash drive  and then stored separately from unique identifier 
subject ID link files.  
 
Emailing Data 
Research data and participant PHI will not be emailed. 
DATA DISCLOSURE/PUBLICATION 
Any publications will only include de-identified data.   
 
CONFLICT OF INTEREST  
The principal investigator and the co-investigators have no conflict of interest with respect to the 
research study. Study participants have all signed Conflict of Interest (COI) forms and 
completed Conflict of Interest training. 
 
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 APPENDICES.  
See attached 1-6 appendices.