Prospective 12-week Randomized Controlled Trial (RCT) of Remotely- Delivered Customized Adherence Enhancement for Poorly Adherent Individuals With Schizophrenia (CAE-S) vs Enhanced Treatment as Usual (eTAU)
Phase: NA
Conditions: Schizophrenia
Sponsor: University Hospitals Cleveland Medical Center

 
 
 
 
 
 
 
 
 
 
Prospective 12-week randomized controlled trial (RCT) of remotely- delivered Customized 
Adherence Enhancement for poorly adherent individuals with schizophrenia (CAE-S) vs 
Enhanced Treatment as Usual (eTAU) 
 
NCT number: NCT06061952 
 
Document Date: 12/2/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Objectives  
This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely 
delivered CAE among patients with schizophrenia (CAE-S). The project will be operationalized 
in 3 specific aims. 
 
Aim 1:  To determine the feasibility and acceptability of administering CAE-S via 
videoconferencing to patients with schizophrenia. Based on this team’s previous work in 
developing and delivering CAE to individuals with SMI who are poorly adherent with prescribed 
oral antipsychotic medication10 and the team’s previous work in remotely-delivered engagement 
and adherence promotion approaches15, we expect that patients with schizophrenia will be able 
to receive CAE-S via a telehealth platform and find it highly acceptable.   
H1: We expect that CAE-S participants will attend an average of at least 4 CAE sessions.  
H2: We expect that at least 75% of participants will agree or strongly agree that the intervention 
was useful. 
 
Aim 2: To test the pragmatic, clinical effects of CAE-S vs. Enhanced Treatment as Usual 
(eTAU) on schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale 
(PANSS) in a randomized control trial (RCT) of 36 poorly adherent patient with schizophrenia.  
H3: We expect that patients randomized to CAE-S will have greater improvement from baseline 
to 12 weeks on PANSS improvement vs. individuals randomized to eTAU. 
 
Aim 3: To explore the effects of CAE-S in improving self-reported medication adherence as 
measured by the Tablets Routine Questionnaire (TRQ) and validated by electronic pill monitoring 
(eCAP). We expect that individuals who have improved symptoms of schizophrenia will also have 
psychotropic medication adherence (TRQ) improvements and improvements in other secondary 
health outcome measures that are relevant to people with schizophrenia at 12 weeks compared 
to those randomized to eTAU.  
 
Background 
Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia, but 
rates of full or partial non-adherence exceed 60%1-3.  There is direct correlation between non-
adherence and rates of relapse in schizophrenia4. On average, non-adherent patients have a 
risk of relapse that is 3.7 times greater than their adherent counterparts5. Second generation 
oral antipsychotic medications are effective and better tolerated than first generation but 
adherence remains low due to both intentional and non-intentional non-adherence6.  
 
This study team has completed a series of studies showing the feasibility and efficacy of a 
relatively brief, patient-centered customized psychosocial adherence enhancement intervention 
(CAE) in various patient populations including individuals with schizophrenia7-9. In-person 
administration of CAE as an adjunct to standard medical care has been shown to improve 
psychotropic medication adherence, psychiatric symptoms and functioning7-12. CAE targets an 
individual’s specific barriers to medication adherence, has been manualized for broad scale-up 
and appears acceptable to individuals with serious mental illness. An effective behavioral 
program that targets common reasons for missing medication with customized modules has the 
potential to modify long-term medication attitudes, behaviors and outcome trajectories. 
. 

Inclusion and Exclusion Criteria 
 
 
Inclusion Criteria 
1. 
Individuals age 18 and older with schizophrenia as confirmed by the Mini International 
Psychiatric Inventory (MINI).  
2. 
Prescribed an antipsychotic medication for treatment of schizophrenia. 
3. 
Have medication treatment adherence problems as identified by the Tablets Routine 
Questionnaire (TRQ, 20% or more missed medications in past week or past month). 
4. 
Ability to be rated on psychiatric rating scales. 
5. 
Currently in treatment or scheduled to receive treatment at a Community Mental Health 
Clinic (CMHC) or other clinical setting able to provide mental health care during and after 
study participation. 
6. 
Able to provide written, informed consent to study participation 
7. 
Has access to electronic device and internet to complete sessions conducted on 
videoconferencing platform. 
 
 
Exclusion Criteria 
1. 
Prior or current treatment with clozapine (clozapine therapy includes additional medication-
related monitoring and clinical visits that may impact medication adherence) 
2. 
Medical condition or illness, which in the opinion of the research psychiatrist, would 
interfere with the patient’s ability to participate in the trial. 
3. 
Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal 
reaction during the course of the study in the clinical opinion of the treated research 
psychiatrist. 
4. 
Immediate risk of harm to self or others. 
5. 
Female who is currently pregnant or breastfeeding. 
 
Study Design 
The project will be implemented as a prospective 12-week RCT of CAE-S vs. enhanced 
treatment as usual (eTAU) in 36 poorly adherent individuals with schizophrenia. Patients with 
schizophrenia will be randomly assigned to receive either CAE-S or eTAU following the baseline 
assessment. The primary feasibility outcomes will be attendance and patient satisfaction (Aim 1) 
and change from baseline to 12 weeks in schizophrenia symptoms as measured by the Positive 
and Negative Symptom Scale (PANSS) (Aim 2). An exploratory evaluation (Aim 3) will examine 
the posited mechanistic underpinnings of the CAE-S intervention by assessing change from 
screening to 12 weeks in psychotropic medication adherence as measured by the Tablets 
Routine Questionnaire (TRQ) and validated by eCAP (objective bottle openings). Secondary 
measures will include the Clinical Global Impression (CGI), functional status, quality of life and 
attitudes towards medication. Findings will be summarized in at least one manuscript submitted 
for peer-reviewed publication, paving the way for a larger-scale trial, and will help inform 
clinicians on care approaches which may optimize antipsychotic medication response in their 
patients with schizophrenia.  
Customized Adherence Enhancement (CAE) Intervention: CAE is an adjunctive (to standard 
medication treatment) behavioral intervention delivered virtually (real-time one on one video-
conferencing) in 6 individual sessions. Because the CAE manual does not target any specific 
oral antipsychotic medication or group of antipsychotic medications, (it is unbranded) positive 

findings from the proposed trial will enhance potential usability across a broad variety of oral 
antipsychotic medications. 
All participants will receive content from the 4 currently existing CAE modules delivered over a 
6-session series spaced out over approximately 6-10 weeks.  The material from the 4 modules 
will be broken down into predetermined sub-sections and delivered in 6 sessions. The modules 
themselves are delivered in sections (thematic units within the module) and do not correspond 
to a specific session. For example, units of the Psychoeducation module are delivered in 
multiple CAE sessions. The reason for this is threefold:  
 
1) To limit the amount of psychoeducational (or other) material in any one session;  
2) To reinforce material that is presented in one session in subsequent sessions, and  
3) To provide patients with the opportunity to absorb and practice strategies in between 
sessions. 
 
While previous studies targeting other patient populations have delivered CAE in 4 core 
sessions and 1 booster session, given the fact that this population is expected to be more 
impaired and the fact that we are delivering the intervention remotely, it is even more important 
that sessions not be too long and that material is both repeated and reinforced. The slower-
paced virtual delivery of the existing CAE content to patients with schizophrenia represents a 
reduction in content –per-session as compared to the in-person version. Each session, 
delivered by a mental health counselor (such as a licensed social worker, mental health 
counselor or advanced trainee supervised by PhD level clinician scientist) lasts from 30-45 
minutes.  It has been our experience that longer video-delivered /telehealth sessions are more 
challenging to implement vs. in-person visits due to lagging of attention and  “zoom fatigue”, 
especially among people with serious mental illness who may already be experiencing cognitive 
difficulties and/or sedation due to psychotropic medication treatments. 
 
While previous studies based module selection on self-reported items completed at screen, in 
the schizophrenia trials, most patients received the majority of modules7. The 4 CAE modules 
are Psychoeducation, Communication with Providers, Medication Routines, and Substance 
Use. Based on the screening evaluation of substance use/abuse as a potential impediment to 
adherence, individuals will receive either a more intensive (MI) vs. less intensive (LI) content 
version of this module.  
a. MI version: This is for individuals who are currently using a substance and will include an 
interactive discussion on the person’s current and past substance use history. The MI 
version targets identifying problems experienced as a result of substance use, 
information on the effects of excessive drug/alcohol use generally and on medication 
treatment and adherence specifically, assessment for the person’s readiness for change, 
the completion of a decisional balance worksheet, as well as a change plan worksheet 
(2 be carried out in 2-3 different sessions).    
b. LI version: This is for individuals who either do not use substances at all (perhaps 
because they are in recovery), or individuals deemed to use only moderately. In the 
former case, there will be an interactive discussion on the person’s substance use 
history including a review of problems caused by substance use and its impact on 
psychiatric symptom management. This is then followed by information on the effects of 
excessive drug/alcohol use generally and on medication treatment and adherence 
specifically, and reinforcement for changes that could be implemented. For those who 
report that they have never had an issue with substance use, the interactive discussion 
on substance use will be briefer, however information on the effects of excessive 

drug/alcohol use generally and on medication treatment and adherence specifically will 
be presented. The low intensity version will be completed in a single session. 
 
Enhanced Treatment as Usual (eTAU):  Individuals in eTAU will receive an eCAP for their 
foundational antipsychotic medication and continue to receive care, including prescribed 
antipsychotic medication with their current non-study providers.  Medication adherence behavior 
typically transiently improves during early phases of focused monitoring (Hawthorne effect), but 
this wanes over time16  with expected regression to behaviors existing prior to study enrollment 
unless otherwise reinforced with an approach like CAE. To optimize control intervention rigor, 
the eTAU participants will view a pre-taped series of videos (based on NAMI or DBSA general 
wellness guidelines) 1:1 with a therapist who has similar credentials and competency as the 
CAE mental health clinician during 6 one-on-one sessions lasting at least approximately 30 
minutes.  The therapist will view the videos with the participant and field questions the patient 
may have. This controls for attentional effects, an important consideration in behavioral clinical 
trials. As an additional consideration to optimize rigor, while study staff are not blinded to 
intervention assignment, outcomes assessments are collected by non-interventionist research 
staff, and outcomes data analysts are blinded to the nature of intervention assignment.  
 
Concomitant medications: This project will not involve the administration of any study drug. 
CAE is intended to be an adjunct to any standard medication treatment for patients with 
schizophrenia, and, to increase potential for scale-up and generalizability, CAE can be 
administered during any phase of medication treatment, including when treatment first begins, 
during any medication cross-tapers or in the case of polypharmacy treatment. All patients will be 
receiving treatment with an FDA-approved oral antipsychotic medication, a first-line treatment 
for schizophrenia as prescribed by their non-study prescribing clinicians.  An essential 
component of CAE is to empower patients and encourage them to communicate with their 
prescribing clinician when they encounter common roadblocks to staying on track with 
medications such as side effects or problems with remembering to take the dosing regimen.  
Participants will also remain on any concomitant medications prescribed by their non-study 
clinician. The study team will assess medication treatments (drug categories, dosage) and 
adherence with antipsychotic drugs and all other maintenance treatment with psychotropic 
medications (TRQ for all prescribed psychotropic treatments, eCAP assessment of foundational 
antipsychotic drug and directly-observed pill counts done via videoconference) at each research 
assessment study visit. 
 
Study Procedures 
 
Outcome measures:  
Study Measures:  As part of the initial clinical evaluation, information will be collected on 
participant previous illness history including duration of psychiatric illness, previous 
hospitalizations, previous suicide attempts, medication treatment history (including history of 
previous treatment-related adverse events), previous history of legal problems and 
incarcerations and cumulative medical burden as evaluated by the self-reported Charlson Index. 
 
Primary Outcomes: 
For Aim 1, primary outcomes for feasibility and acceptability will be assessed via CAE-S 
attendance (number of sessions attended out of all scheduled sessions) and self-reported 
patient satisfaction with CAE-S respectively.  

For Aim 2, primary outcomes will be schizophrenia symptoms using a standardized, validated 
measure.  
 
Attendance and Patient Satisfaction: Attendance will be evaluated as the number of attended 
CAE sessions (out of a total possible attendance of 6 sessions). This will be a simple count of 
ranging from 0 (no attended session) to 6 (attended all sessions).  In previous work, using CAE 
to promote oral antipsychotic medication adherence among seriously mentally individuals who 
were poorly adherent, average attendance was 76% with in-person sessions10. While we 
believe that attendance will be greater for remotely-delivered vs. in-person, we conservatively 
estimate that the average attendance with CAE-S will be at least 4 sessions.  
 
Treatment satisfaction will be assessed using a series of self-report items measured on a 5-
point Likert Scale from strongly disagree to strongly agree regarding different aspects of the 
intervention (e.g. the length of sessions, # of sessions, content covered, etc.). This method has 
been used successfully by our team in multiple treatment outcome studies.7-12 In previous work 
using CAE to promote oral antipsychotic medication adherence among poorly adherent 
individuals with serious mentalillness, 90% felt that the benefit of the intervention exceeded the 
burden, most (90%) felt that CAE was “about right” in the number of sessions and timing, and all 
strongly agreed or agreed that CAE addressed all important issues specific to their situation.10 
 
Schizophrenia Symptoms: Symptoms of schizophrenia disorder will be assessed using the 
Positive and Negative Syndrome Scale (PANSS) developed by SR Kay et al17.  The PANSS is 
very widely in research settings. Alpha-coefficient analysis has indicated high internal reliability 
and homogeneity among PANSS items, with coefficients ranging from 0.73 to 0.83 (p <.001) for 
each of the scales. The split-half reliability of the General Psychopathology Scale was 
demonstrated to be 0.80 (p <.001). The authors have also demonstrated the discriminate and 
convergent validity of the PANSS dimensional assessment in relation to independent clinical, 
genealogical, psychometric, and historical measures. 
 
Adherence Behavior: Adherence will be evaluated with the self-reported Tablets Routine 
Questionnaire (TRQ) for the past week and the past month. Self-reported adherence will be 
validated with eCaps, an automated pill-monitoring system.  While it is true that the literature on 
measurement of adherence, including the co-PIs’ work in this area notes limitations with all 
methods of adherence assessment, both self-report and automated pill-caps appear valid and 
practical for use in schizophrenia studies.16,18  In addition to the TRQ, using the videoconference 
platform, research staff will also conduct a directly-observed pill count to augment the eCAP 
real-time bottle opening record. 
 
Tablets Routine Questionnaire (TRQ): TRQ is a measure which quantifies the proportion of 
days with missed doses over the past week and the past month.  A total combined adherence 
score (proportion of days with missed doses out of total medications prescribed) will be 
calculated as an average of the TRQ values of all orally-prescribed medications.  The TRQ has 
been noted by other investigators to be reliable and responsive to change in seriously mental ill 
populations including in individuals with schizophrenia7,19-21. The TRQ is not dependent upon 
timing of medication provided that medication is consumed within the required day/24 hour 
period.  
 
eCaps: Electronic monitoring of pill container openings is an important method of measuring 
adherence. The methodology employed in this study will be an eCAPTM.22 Pill bottles equipped 
with eCAPS are capable of storing a 90-day supply of one medication. The eCAP records 
openings. This provides a precise, objective assessment of the timing of each dose and the 

patient’s pattern of pill-taking behavior. Although many patients with schizophrenia take multiple 
antipsychotic medications, we will monitor the antipsychotic dosed most often (index drug). If 
more than one drug is dosed at the same frequency, the antipsychotic most recently added to 
the regimen will be the index drug. As-needed or “prn” drugs will not be monitored. In previous 
work by this study team, the correlation between a single “index” drug and all drugs was 0.95 
providing support for measuring one medication as proxy for medication adherence.23 The 
method of choosing an index drug also limits participant burden. To ensure that the data 
collected represent pill-taking behavior as accurately as possible, patients will be instructed to 
(1) dispense doses of their monitored medication only from the eCAP equipped bottle, (2) 
remove only one dose at a time, and (3) remove a dose only at the time that they plan to 
swallow the medication. Adherence is defined as the % of pills missed, and a ratio of number of 
doses missed to number prescribed will provide a percentage, with a higher value indicating 
poorer adherence. While just assessing adherence behavior may temporarily increase 
adherence (e.g., the Hawthorne effect), it is expected that any potential impact on adherence 
behavior will wane over the 3 month follow-up.  A large recent clinical trial demonstrated limited 
long-term adherence advantage for passive medication aids (e.g., 7-day pill organizer, pill cap 
displaying time since last dose), a category into which eCAP would fall.24 Experience with eCAP 
conducted by this team yielded substantially less missing data using the eCAP than the MEMS. 
Adding an extra financial incentive for bringing in the eCAP ($10 per visit) optimizes use of 
automated pill-monitoring. Notably, in a recent pilot study, 31/38 participants (81.6%) brought 
their eCAP to all 3 study visits over a 6-month period.25 To optimize generalizability, individuals 
who use medisets or pill-minders to manage multiple medications will not be excluded from the 
study. We will follow the same procedure that we did for a recent study which was very 
effective. Only one medication will be tracked via eCAP. All other medications can remain in the 
pill-minder or other medication tracking device. The medication is placed in the eCAP by the 
research assistant (RA) when setting up the device if in person or the RA will instruct the 
participant to do so during their video-conferencing meeting. Participants will be trained on the 
use of eCAP and will have the opportunity to practice opening the cap before it is activated.  
Other outcomes of interest: 
 
Adherence Attitudes:   
The Drug Attitude Inventory (DAI), is used to measure attitudes towards medication among 
individuals with serious mental illness26 and is known to be relatively unaffected by psychiatric 
symptom severity27. The DAI was originally developed to assess the attitudes and subjective 
experience of patients with schizophrenia being treated with antipsychotic medications. The DAI 
is a simple, true-false format questionnaire that assesses domains of patient’s attitudes 
including positive and negative experience, locus of control, and attitudes towards health. 
Responses are scored on a euphoric-dysphoric continuum (alpha= 0.93). 
 
Patient-Reported Outcomes Measurement Information System (PROMIS) Medication 
Adherence Scale (PMAS)28 is a 9-item self-report measure which targets the multiple potential 
reasons patients with various chronic health conditions may not adhere to their medications. 
The measure was developed using rigorous methodology28 and can be used to compare to 
other adherence studies. 
 
Health Resource Use: Resources that are typically utilized by the most severely ill individuals 
with schizophrenia include emergency care and hospitalization.  Resource use in the 3-month 
period prior to study enrollment and during the 3-month study period will be evaluated. 
 
Global Psychopathology: Global psychopathology will be measured with the Clinical Global 
Impressions (CGI)29 a widely used scale which evaluates illness severity on a 1 to 7 point 

continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 
0.41-0.6629 and correlate with the BPRS30. 
 
Social Functioning: Life and Work Functional status will be evaluated using the GAF and the 
Strauss-Carpenter Level of Functioning Scale (SCLFS). The GAF is a 100-point single-item 
scale which measures global functioning of psychiatric patients and is widely utilized in clinical 
studies involving Seriously Mentally Ill patients.31  The reliability of the GAF ranges from 0.62-
0.82. Additionally we will use the SCLFS which measures functioning in four areas: symptoms in 
the previous month, hospitalizations, work, and social contacts in the previous year.32 
Functioning in each area is rated on a scale from 0, worst functioning, to 4, best functioning.     
 
Alcohol and Substance Use: The Alcohol, Smoking and Substance Involvement Screening 
Test (ASSIST) is a widely used and validated 8-item measure of alcohol and drug use (World 
Health Organization ASSIST Working Group, 2002).33  
 
Quality of Life (QoL):  The Short Form Health Survey (SF-12) will be used to assess health 
related quality of life.34 This 12-item self-report Health-related Quality of Life measure has an 
index for mental health and an index for physical health and has been validated in individuals 
with serious mental illness.35   
 
Schedule of Events 
 
Screen 
Baseline 
(~1 week after 
screen) 
Weeks 2-8 
12 weeks 
Screening, Informed consent 
X 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
Demographics 
X 
 
 
 
Diagnostic Interview (MINI) 
X 
 
 
 
Medical burden (Charlson) 
X 
 
 
 
Randomization 
 
X 
 
 
eCAP administration and 
training 
X 
 
 
 
Primary Outcome:  
Schizophrenia Symptoms -
PANSS 
 
X 
 
X 
Secondary outcomes: 
Adherence Behavior:  
TRQ, directly-observed pill 
counts and eCAP* 
X 
X 
 
X 
Secondary outcomes: 
 
X 
 
X 

 
*eCAP data collection will start at baseline following distribution at screen 
Figure 1: Study Design 
 
Data Analysis Plan 
Statistical Analysis: Our study proposes to assess the primary outcome of change from 
baseline to week 12 on the PANSS.  Expected magnitude of change is informed by results of 2 
previous studies using CAE in schizophrenia by these PIs (Sajatovic 2013, Sajatovic 2017).  We 
will conduct descriptive analysis of baseline variables (i.e., age, gender, ethnicity, and level of 
education).  The PANSS total will be a sum of global symptoms of schizophrenia. First, we will 
compare the changes in PANSS from baseline to 12 weeks, respectively, for the CAE-S and 
eTAU groups using a non-parametric Wilcoxon rank-sum test to determine whether the 
subgroup medians differ.  Should baseline-covariates differ between subgroups, we will conduct 
the appropriate multivariable linear regression for normalized outcome measures, to account for 
residual confounding.  Analysis of the secondary outcomes will be conducted in a similar 
manner.  An intent-to-treat analysis will be conducted. We will assess the missing at random 
assumption for the mixed models for missing data due to dropout or missed assessments.    
We project a sample size of 36 subjects, randomized in equal numbers (CAE=18, eTAU= 18).  
In our previous study using CAE and long-acting injectable antipsychotic medication in 
homeless individuals with schizophrenia, 10 (33%) out of 30 subjects dropped out after 24 
Adherence Attitudes:  
   DAI, PROMIS 
Global Psychopathology: CGI 
Social Functioning: Strauss-
Carpenter 
Alcohol/Substance Use:  
ASSIST  
Quality of Life: SF-12 
Health Resource Use 
CAE sessions/attendance 
ETAU sessions/attendance 
 
 
X 
 
Participant satisfaction 
 
 
 
X 

weeks, including 3 (10%) due to incarceration (thus, 23% due to other discontinuation reasons).  
This study will not specifically enroll homeless individuals, but rather those who are on oral 
antipsychotics prescribed by the patient’s outpatient clinician; thus, we believe the attrition 
proportion will be substantially smaller for the proposed study.  Additionally, since the duration 
of observation in the proposed study is 12 rather than 24 weeks, this is expected to optimize 
study retention. Nonetheless, for the power calculation we hypothesize an attrition of up to 23% 
(N=8), a one-sided alpha of 0.05 (because we hypothesize CAE will result in improvements 
based on our pilot studies) For PANSS, we previously observed an average decrease in the 
composite score from baseline of 6.7 (SD = 7.1), there is 77% power for a sample size of 28. 
Thus the sample size of 36 individuals enrolled is appropriate for this conservative estimate of 
attrition. For our exploratory aim, adherence is calculated as a percentage of self-reported 
proportion of oral medications missed. Automated pill monitoring (eCAPS) will be used to 
validate the TRQ and we expect that CAE will improve adherence at week 12 from screen at 
least as comparably as it did in our study of homeless iandividuals7 (average TRQ improvement 
past week = 37%; SD = 36.9%). For a Wilcoxon rank-sum test, we expect there will be minimal 
change in adherence in the eTAU group at week 12 – for which we have 81% power to detect a 
difference; even if the eTAU group reports a 5% change, there is still 71% power to detect a 
difference. 
Risks to Research Participants 
Any time information is collected, there is a potential risk for loss of confidentiality. There are no 
other known risks of harms or discomforts associated with this study beyond those encountered 
in normal daily life.  Some of the activities we will ask you to complete might make you feel 
uncomfortable or tired.  Participants may refuse to answer any of the questions, take a break, or 
stop your participation in this study at any time.   
 
Provisions to Protect the Privacy Interests of Research Participants 
Confidentiality of research data will be protected in several ways. Patient identifiers at the analytic 
level will not be the same as the patient’s clinical medical record number. The files that link the 
patient identifiers to the study numbers will be kept in locked cabinets in the PIs office. Only 
aggregate data will be presented or published and will be presented such that individual patients 
cannot be identified. The proposed project’s research personnel who will have access to subject 
identities are the study PI, co-investigators, and the study research assistants. All study personnel 
will be required to be certified in the protection of human subjects throughout the study.   
Potential Benefit to Research Participants 
There is no direct benefit from participation in this study. 
 
Participant may find it helpful to participate in the educational sessions and/or watch the 
wellness videos. It is possible that the interventions may help participant remember to take their 
medication. Information obtained in this study may help improve care for other patients 
 
Withdrawal of Research Participants 
Participation is voluntary.  There is no penalty or loss of benefits for not participating or for 
discontinuing your participation.  
 

Participant is free to withdraw from this study at any time.  The research team may also end 
participation in this study if they do not follow instructions, miss scheduled visits, or if safety or 
welfare are at risk. 
 
Alternatives to Participation 
Alternative to participation is to not participate 
 
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