Piloting Text Messages to Promote Positive Affect and Physical Activity
Phase: NA
Conditions: Acute Coronary Syndrome
Sponsor: Massachusetts General Hospital

Piloting text messages to promote positive affect and physical activity—April 16, 2019 
 
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I. Background and significance 
A. Historical background 
Every year, over 1.3 million Americans suffer an acute coronary syndrome, or ACS (myocardial 
infarction or unstable angina).1 Of these post-ACS patients, approximately 20% will be rehospitalized 
for ischemic heart disease or suffer mortality within the next year.2 Adherence to recommended post-
ACS health behaviors—especially increasing physical activity—is associated with substantially lower 
risk of recurrent events and mortality.3,4 However, the majority of ACS patients have not been able to 
increase their activity to recommended levels.1,3,5  
Positive psychological constructs, such as optimism, are associated with greater adherence to 
evidence-based recommendations for physical activity,6 as well as lower rates of heart disease and 
cardiac mortality.7,8 Exercises that aim to cultivate positive cognitive and emotional experiences, known 
as positive psychology (PP) interventions, utilize short tasks that focus on gratitude (e.g., counting 
blessings), altruism (e.g., performing kind acts), use of personal strengths, and related constructs.9 PP 
interventions have been extensively studied and found to reduce distress and improve psychological 
well-being in a total of over 6000 participants.10  
Given the connections between positive psychological constructs and health behaviors, and an 
ongoing need for innovative, feasible, and effective methods of improving health behaviors, PP 
interventions may provide a novel approach to increasing adherence and improving cardiac outcomes in 
ACS patients. Thus far, there has been limited study to assess whether PP interventions can promote 
health behaviors,11,12 and prior to our pilot work in this area,13 no study had evaluated a PP intervention 
in post-ACS patients.  
In addition, interventions to improve health have increasingly begun to focus on mobile health 
(“mHealth”) interventions to deliver text-based messages containing suggestions, support, education, or 
other specific content. These ecological momentary interventions (EMIs) can be tailored to the 
individual and implemented in real time (i.e., daily life).14 Mobile or electronic devices can be used to 
provide these interventions in the daily lives of individuals. With a web-based survey, Proudfoot15 
showed that 76% of the general population is interested in using mobile technology for either 
monitoring or self-management of health. Using EMIs has numerous advantages such as the ability to 
reach large populations at lower costs,16,17 especially given that the number of worldwide mobile phone 
users is immense and continues to expand.18 A recent meta-analysis found that PP-related EMIs were 
found to be effective in improving mental health and positive psychological well-being.19 Furthermore, 
an EMI intervention focused on providing lifestyle-based one-way text messages (e.g., promoting 
healthy diet, health screening, and physical activity) led to improvement in cardiac risk factors.20 
However, no prior intervention has examined the use of text-based messages in the key 
population of post-ACS patients, In addition, prior work has not examined a combination of messages 
that promote both positive psychological constructs and education/support around health behavior 
adherence, such as physical activity or diet. This may be a promising approach given that a combination 
of psychological and health education interventions may have greater effects on health behavior 
adherence than either alone.21 
 
B. Preliminary studies 
Our team has experience delivering PP interventions, in person and by phone, to numerous 
patients with depression, multiple sclerosis, diabetes, and most relevant to this IRB proposal, post-ACS 
patients. We have found that these interventions have been associated with improvements in positive 
affect, depression, anxiety, and health-related quality of life. We also have experience delivering health 
education/motivation interventions in over 100 post-ACS patients as part of a combined PP/goal-setting 
intervention for physical activity.21 However, we do not yet have experience delivering elements of 

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these interventions by text messaging, which could serve as an ideal adjunct to promote maintenance of 
effects after a more intensive initial intervention, or as a promising stand-alone intervention.  
 
 
C. Rationale for proposed research and benefits to patients and/or society 
 
Given: (a) the relationship between psychological well-being and health behavior 
adherence/superior cardiac outcomes, (b) the potential for combined PP and educational interventions to 
improve adherence more than either alone, and (c) the acceptability and impact of health-related text 
messaging on health outcomes in cardiac patients, the use of combined PP-based and health behavior-
related text messages in post-ACS patients has the potential to increase physical activity and reduce 
adverse events in a high-risk, high-yield population of patients. This would have direct benefits to 
patients and would impact public health, given that >1 million Americans suffer an ACS each year. 
Given that most post-ACS patients (mean age ~6022,23) would likely not be used to receiving healthcare 
related interventions remotely, key first steps are to determine whether post-ACS patients are willing 
and able to receive such text messages, whether they find the messages acceptable, and whether they 
lead to short-term changes in self-reported psychological and behavioral outcomes.  
 
II. Specific Aims 
We will conduct a pilot one-arm project delivering 7 text messages/week containing messages 
related to PP activities (e.g., recalling positive events), having a heart-healthy diet, or becoming more 
physically active, for 4 weeks among 80 patients with a prior ACS.  
 
Specific Aim 1: To assess the feasibility and acceptability of a pilot text-message-based intervention for 
post-ACS patients (primary aim). 
Hypotheses: Over 50% of eligible patients will enroll in the project and text messages will be 
successfully delivered to over 90% of enrolled participants. In addition, participants’ mean ratings of the 
intervention’s burden (<4/10) will suggest that the intervention is well-accepted. 
 
Specific aim 2: To examine the short-term impact of the intervention on relevant self-reported 
outcomes. 
Hypotheses: Participants will have mean pre-post increases in positive affect, optimism, determination, 
depression, anxiety, self-reported physical activity, self-reported dietary adherence, and self-rated 
health/function.  
 
Specific aim 3: To understand ACS patients’ experience, via open-ended interviews, receiving text 
messages in this project regarding the preferred frequency, duration, timing, and content of the text 
messages, along with any specific benefits obtained from participation.  
Hypotheses: Though qualitative research does not have formal hypotheses, we expect that participants 
will find that this frequency and duration of messaging was acceptable, and that the positive 
psychological and physical activity-based messages will be experienced as equally beneficial. 
 
III. Participant Selection 
The convenience sample for this pilot study will be enrolled from two sources: (a) participants 
prospectively enrolled from inpatient cardiac units at MGH admitted for an ACS, and (b) participants in 
prior post-ACS studies performed with our team (specifically the observational Gratitude Research in 
Acute Coronary Events [GRACE] study [PHS IRB 2012P001191], and two linked Positive Emotions in 
Acute Coronary Events [PEACE] studies [PHS IRB 2013P001961 and 2014P001756]).  

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A. Inclusion/exclusion criteria 
 
Inclusion criteria: patients eligible for this pilot study must meet the following criteria: 
 
1. Prior acute coronary syndrome. To have received a diagnosis of ACS, patients must have met 
criteria for acute myocardial infarction (MI) or unstable angina (UA). For MI, potential subjects must 
have met established consensus criteria,24 specifically elevation of cardiac biomarkers (cardiac troponin 
T) in addition to: (1) symptoms of ischemia (e.g., acute chest pain), (2) ischemic changes on 
electrocardiogram (e.g., ST-segment elevation or ST-depression and T-wave inversions), or (3) imaging 
evidence of new loss of viable myocardium or new regional wall motion abnormality. For UA, subjects 
met formal standardized criteria used in prior cardiac studies:25,26 (1) crescendo angina, (2) new onset 
(within 1 month) angina with minimal exertion, or (3) angina with minimal exertion or at rest. When 
unclear, diagnoses will be clarified with the primary treatment team and adjudicated by the study 
cardiologist (Dr. James Januzzi [J.J.])  
 
2. Ability to receive text messages via cellular phone. Participants must have a cellular phone that: (a) 
can receive text messages, (b) that they use or check (e.g., checking for voicemail or email messages) at 
least daily, and (c) that has an unlimited text message plan (to prevent the study text messages causing 
them to be charged for reception of the messages).  
 
Exclusion criteria: patients will be excluded if they had:  
 
1. A periprocedural ACS (ACS occurring in the setting of another medical procedure) 
2. A medical condition likely to be terminal within the timeframe of the study 
3. An unrelated condition limiting physical activity 
4. An inability to communicate in English, or  
5. A cognitive disturbance precluding participation or informed consent, as identified using a six-item 
cognitive screen designed to assess suitability for research participation.27  
 
Patients with a periprocedural ACS will be excluded due to concerns that such events may occur in the 
absence of structural heart disease and likely represent a different pathophysiology, course, and 
prognosis than those with 'endogenous' ACS. Those unable to complete physical activity due to an 
unrelated medical condition (e.g., arthritis) will be excluded because the intervention is focused on 
promoting activity and because this would impede measurement of one study outcome (self-reported 
physical activity). Furthermore, for all patients, we will only enroll them if they have no 
contraindications to physical activity per their primary cardiology team. Overall, determination of 
exclusion criteria will be made in conjunction with the primary medical team (e.g., regarding comorbid 
or terminal conditions) with consultation and adjudication from the study team cardiologist (J.J.) as 
needed.  
 
B. Source of participants and methods of recruitment  
Regarding hospitalized patients, recruitment and informed consent procedures for hospitalized 
cardiac patients will be highly similar to those used for our prior PP studies occurring in ACS patients 
on cardiac units that occurred on the same units (Partners Healthcare System [PHS] IRB 2013P001961, 
2014P001756) and involved very similar inclusion/exclusion criteria. Specifically, two cardiac inpatient 

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units (Ellison 10 and 11) will serve as the source of subjects for the study. Potential subjects will be 
those patients who are admitted with a primary diagnosis of ACS. To recruit subjects, study staff will 
review electronic patient censuses with the study team physician investigators to ensure that the patient 
indeed appears to have been admitted with an ACS and to identify any specific clear contraindications to 
participation (e,g., periprocedural ACS noted in record). Study staff will then approach treatment 
providers on the care unit to inquire about the accuracy of the ACS diagnosis for such patients. If a 
potentially eligible patient is identified, the study staff member will ask the treatment provider 
(physician, nurse, or nurse practitioner) to ask the patient whether it would be okay for a study staff 
member to inform the patient about an optional study on the unit. If the patient is amenable, a study staff 
member will discuss the study with the patient and assess for inclusion/exclusion criteria. 
Regarding recruitment of patients who were in our team’s prior studies, we will send them opt-
out letters by mail (see letters), signed by the study principal investigator. These letters will explain that 
we are recruiting potential participants for this study. The letter will describe that if they do not wish to 
receive a call explaining the study, they can call the study team opt-out line to inform the study team. If 
the team does not receive an opt-out call after 2 weeks, a study coordinator will call the potential 
participant (who will have had an ACS, confirmed using the above criteria, based on their qualification 
for the prior study) and describe the study. The staff member will clarify that this is an optional, separate 
study from the one in which they previously enrolled.  
 
IV. Participant enrollment 
 
A. Methods of enrollment/Procedures for obtaining informed consent 
For hospitalized patients, if the patient is interested in the study after the discussion as mentioned 
above, a study coordinator or physician will approach the patient to further discuss the study. If the 
patient is willing, the staff member will directly assess for inclusion criteria (especially related to 
cellular phone availability and use) and exclusion criteria (e.g., comorbid medical illnesses/prognosis 
and cognitive deficits, as assessed by study staff using the six-item screen). Next, if the patient meets 
study criteria and is interested in the study, the study staff member will verbally discuss the study in 
detail and give the patient adequate time to read a written IRB-approved consent form and to ask 
questions. To ensure that subjects have the capacity to provide informed consent, we will ask potential 
subjects to describe their understanding of the study’s purpose and their role (e.g., that they understand 
the timing of text messages and study assessments and their purpose, confidentiality and its limits, and 
their ability to end participation in the study at any time for any reason). Patients will be given as long as 
they would like to sign consent (they can complete baseline procedures by phone after discharge if they 
enroll later). Finally, once subjects sign the consent form, the investigator will perform a focused review 
of the subject’s medical record (including laboratory data) to again confirm that the patient was admitted 
for ACS, and will consult with the study cardiologist in the event that there is any need for further 
clarification. If there is a question about the patient’s medical prognosis (to assess whether the patient 
has a condition likely to lead to death within 6 months) the study team will consult with the inpatient 
treatment team (and the study cardiologist as needed). 
For participants from prior studies, if the patient is potentially interested in the study, the study 
coordinator will assess the patient for inclusion and exclusion criteria, and if the patient is eligible and 
willing to participate, we will mail the patient a consent form (and the coordinator will call the patient to 
ask if there are any questions about the form or the study), and upon receipt of the signed consent form, 
the participant will be enrolled. We will also ask the participant if they are able to “walk a block or two 
on level ground,” to ensure they are able to safely partake in physical activity. If they answer “no,” to 
this question, we will offer to inquire with their medical provider whether physical activity (such as 

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walking) is safe, and when needed in such cases, will obtain a release of information to do so.  
In all cases, once patients are confirmed subjects in the study, they will complete a series of 
baseline assessments (see below).  
 
B. Treatment assignment 
Participants will be enrolled and complete written informed consent as described above. All 
participants will be assigned to the active/experimental condition (receiving 7 text messages/week for 2 
weeks) for the purposes of this pilot/proof-of-concept study.  
 
V. Study procedures 
A. Study visits 
Baseline assessment and orientation to the intervention. For patients enrolled during 
hospitalization, we will contact these participants 2 weeks post-discharge by phone to complete the 
baseline assessment and the orientation visit to initiate text messaging. This timing will ensure adequate 
recovery such that participants will be able to complete physical activity upon beginning the intervention 
(given that the majority of ACS patients are able to engage in basic physical activity such as brisk 
walking within a week of discharge). For participants from prior studies enrolled via the opt-out letters, 
the study team will contact them upon receipt of the signed consent form by mail to complete baseline 
assessments and intervention orientation.  
The baseline assessment will consist of gathering of basic demographic information and 
completion of very brief self-report assessments about psychological, health behavior, and overall 
health/functional outcome measures (see below for further detail). Upon completion of this assessment, 
the study coordinator will describe the role of the text messages, specifically describing that participants 
will receive text messages daily for 4 weeks. The coordinator will reiterate the rationale for the 
project—that completing exercises to boost mood and optimism may translate into greater well-being, 
vitality, and energy (and being more active), and that specific reminders and support around becoming 
more active may more directly promote activity. The coordinator at that contact will also transmit a test 
text message to confirm successful transmission of such messages. 
2-Week Check-in. During week 2 of the intervention, the coordinator will contact the patient 
over the phone to receive any feedback, answer any questions the participants may have, and to 
reinforce the purpose of the study. 
Follow-up assessment #1. After completion of the text messaging intervention (week 4), 
participants will be contacted by phone to repeat the self-report assessments, and to complete 
quantitative (2 questions) and qualitative (15 minute interview) questions about the intervention.  
Follow-up assessment #2. Four weeks later (week 8), participants will once more complete the 
self-report assessments (without interview). This will end their study participation.  
 
 
B. Drugs to be used 
 
No drugs will be administered 
 
 
C. Devices to be used 
 
No medical devices will be used.  
 
 
D. Procedures 
A total of 28 intervention text messages (1/day for 4 weeks) will be sent to participants following 
the baseline assessment.  

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Messages will be addressed to participants by name (if desired) and sent at a time of their 
choosing. Immediately following the delivery of the message, participants will receive a second text 
message asking them to rate the utility of the message on a scale of 0 to 10 (0=not helpful at all and 
10=very helpful). A score of 7 or above will be rated “liked” while a score of 6 or below will be rated 
“disliked.” Participants will respond via text message with a rating score, which will be combined with 
prior feedback and then used to select all subsequent messages.  Participants will first receive a set of 14 
preselected daily messages that contain a broad range of attributes to allow sufficient participant 
feedback to clearly identify preferences. Daily adaptation then begins through probabilistic weighting of 
messages based on prior “liked” attributes. To accomplish this, all messages are annotated for multiple 
attributes, which include content type (e.g., PP), specific content (e.g., optimism), nature (e.g., 
information), and whether the message is explicitly prosocial.  
The learning algorithm calculates the proportion “liked” (P) of each message type, using 
messages “liked” and “disliked” of that type and the total number of messages (N) of that attribute with 
feedback. A weighting multiplier (W) specifies the adaptation rate; a larger W leads to more rapid 
favoring of messages with “liked” attributes; we chose W=1.5 for a moderate rate of evolution. The 
values are combined (B = 1 + [W x P x N]) to produce a modifier (B), which changes the probability of 
selecting future messages of that specific type.  
We will deploy the dynamic daily TMI using a database (DynamoDB)28 to maintain and execute 
the adaptive algorithm; the database selects messages based on participant responses. Amazon Web 
Services29 allows communication between this database and the secure text-messaging program 
Twilio30, which securely (HIPAA-compliant) delivers messages to participants  
The messages via this server will be sent using the Twilio texting program used by REDCap, 
which also uses Amazon Web Services (see Twilio security features at https://s3.amazonaws.com/ahoy-
assets.twilio.com/Whitepapers/Twilio_Whitepaper_Security-Architecture.pdf). Twilio allows software 
developers to programmatically make and receive phone calls and send and receive text messages using 
its web service. Our study team has purchased a Twilio account to allow messages to come from an 
anonymous phone number rather than the phone of a study staff member.  
We have piloted the sending of text messages using these methods within the study team and 
found them to be feasible and efficient.  
 
The messages will be signed by the Massachusetts General Hospital Cardiac Psychiatry Research 
Program. Example text messages are listed in Table 1:  
 
Daily messages in adaptive TMI with assignment of specific attributes 
Message 
Main category 
Subcategory 
Education/
Activity 
Prosocial 
Perform 3 kind acts today. 
PP 
Altruism 
Activity 
Yes 
Walking 15 more min/day reduces risk of heart 
disease. 
Physical activity 
Walking 
Education 
No 
Miss one TV show this evening and take a walk 
around your block for at least 15-20 minutes. 
Physical activity 
Walking; TV 
Activity 
No 
Eat a piece of fruit today for an afternoon snack.  
Diet 
Fruit 
Activity 
No 
Eating less red meat is associated with lower 
body weight and lower risk of heart disease. 
Diet 
Saturated fat/ 
cholesterol 
Education 
No 
Table 1. Sample messages and assignment of specific attributes.  
 
 
Participants will be informed that while study staff do not monitor or respond to text messages regularly, 
participants can opt-out of future messages by texting, “STOP” or calling the study team at any time.  

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E. Data to be collected and when data will be collected  
Baseline Assessment 
Upon enrollment, we will collect basic demographic data (age, gender, race/ethnicity) to 
characterize our population. Participants will then complete baseline study assessments: 
  
At baseline we will also collect the following self-report measures: 
(1) Measures of psychological states: 
• Positive psychological states: Participants will rate their levels of positive affect, optimism, 
and determination, over the past week, on a 0-10 Likert scale. 
• Negative psychological states: Participants will also rate levels of depression and anxiety, 
over the past week, on 0-10 scales.  
(2) Measures of health behaviors and function: 
• Self-reported physical activity. Participants will complete a two-item assessment for physical 
activity that has been validated and used in thousands of patients in the Kaiser Permanente 
system.31 We will record completion of moderate activity in number of minutes of 
activity/week. The items are: 
o In the past 4 weeks, how many days/week did you engage in moderate or greater 
physical activity (like a brisk walk)?'  
o On those days, how many minutes do you engage in activity at this level?'  
These two measures are then multiplied to arrive at the average min/week of moderate or greater 
physical activity.  
• Self-reported dietary adherence: Participants will be asked a single item about self-reported 
dietary adherence, adapted from the Medical Outcomes Study Specific Adherence Scale32: 
“In the last month, how often have you followed a low-fat, low-salt, or other diet as 
prescribed by your treatment team?”  Choices will include “None of the time,” “A little of 
the time,” “Some of the time,” “A good bit of the time,” “most of the time,” and “all of the 
time.” 
• Self-reported health: Participants will be asked a single item about self-reported health: 
“In general, how would you rate your health today” with the possible choices being “very 
good” (1), “good” (2), “moderate” (3), “bad” (4) or “very bad” (5). This scale is a robust 
predictor of mortality and correlates strongly with other objective health indicators.33  
Physical function will be assessed with the Duke Activity Status Index (DASI).34 The DASI 
contains 12 items that inquire about activities of daily living (e.g., bathing), basic physical activity (e.g., 
walking, climbing stairs), and more strenuous physical function (e.g., vigorous sports) to gauge overall 
functional capacity. It has been extensively used in cardiac patients,35,36 and is reliable, valid, and 
responsive to change. The DASI predicts prognosis in cardiac patients above and beyond the effects of 
biomarkers,37 and is prospectively associated with new cardiac events38 and cardiac mortality.36  
 
Follow-up assessment #1 
After the four-week text message period, participants will then complete a follow-up assessment. 
The follow-up assessment will consist of the quantitative measures above, in addition to 0-10 overall 
ratings of the intervention’s burden and utility. Finally, they will complete an open-ended 
(approximately 15 minute) interview: 
 
• Receipt: Did you receive the text messages? How many out of the 28 did you receive? 
• Burden/Utility: Were the texts bothersome or annoying? Were they helpful? How?  

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• Were some more helpful than others? Were the texts about happiness or being active more 
helpful? 
• Impact: Did a text ever specifically lead to an action (e.g., activity, a kind act)?  
• Frequency: Were they not frequent enough? Too frequent? Just right? 
• Duration: How long would such a program be useful? Would it be useful to have occasional 
reminders? 
• Content: Any thoughts about additional content that could be included in the messages? 
 
We will digitally record and transcribe the qualitative interviews to allow analyses for themes. 
 
Follow-up assessment #2 
Finally, four weeks later, participants will again repeat by phone the initial self-report quantitative 
measures.  
 
 
VI. Biostatistical Analysis 
A. Specific data variables to be collected for the study 
 
 
B/C. Study endpoints and statistical methods  
 
Specific Aim 1: To assess the feasibility and acceptability of a pilot text-message-based intervention for 
post-ACS patients. 
 
We will record: (a) % of eligible patients who enroll, (b) % of participants who receive text messages, 
(c) % of text messages received, and mean ratings of intervention burden.  
 
Data analysis: We will use descriptive statistics (e.g., proportions, means, standard deviations) to assess 
these outcomes and we will compare them to our hypothesized outcomes: Over 50% of eligible patients 
will enroll in the project, text messages will be successfully delivered to over 90% of enrolled 
participants, and participants’ mean ratings of the burden of the messages at 4 weeks will be <4/10.   
 
Specific aim 2: To examine the short-term impact of the intervention on relevant self-reported outcomes 
 
We will record: pre-post changes in positive affect, optimism, gratitude, determination, depression, 
anxiety, self-rated physical activity, self-rated health, and physical function, at both 4 and 8 weeks  
 
Data analysis: We will use descriptive statistics to calculate the mean and standard deviation of each 
variable at each timepoint, along with the change in each variable between baseline and the follow-up 
Assessment 
Screening Enrollment   4 weeks 
8 weeks 
Cognitive screen (six-item screen) 
X 
 
 
 
Basic demographic information 
 
X 
 
 
Psychological measures (positive/negative) 
 
X 
X 
X 
Self-reported activity, health, and function 
(DASI) 
 
X 
         X 
      X 
Qualitative interview for feedback 
 
 
X 
 

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timepoint(s). We will also examine the effect size (Cohen’s d) of the pre-post change in each outcome 
variable at each timepoint (4 and 8 weeks), calculated by dividing the mean change in the variable by 
the standard deviation of the variable (averaged across timepoints). We will also perform exploratory 
paired t tests for each outcome variable to assess for significant (p<.05, two-tailed) change in these 
variables, though this pilot project would not be powered to detect pre-post changes. We hypothesize 
that the text messages will be associated with a small to medium effect size (d=.2-.5) in these outcomes 
at 4 and 8 weeks.  
 
Specific aim 3: To understand ACS patients’ experience receiving text messages in this project 
regarding the preferred frequency, duration, timing, and content of the text messages, along with any 
specific benefits obtained from participation.  
 
We will record and transcribe responses to the qualitative interviews, and extract themes relevant to the 
above topics. We will not perform quantitative analyses for this aim, but will use the derived theme(s) to 
inform future studies utilizing text messaging in this population.  
 
D.  Power analyses 
As a proof-of-concept/pilot study, we will not be powered to detect pre-post changes in our main 
outcome variables with N=80(and estimated 10-15% dropout based on prior studies). However, this 
study will provide us very useful information on feasibility/acceptability and some useful preliminary 
data on the potential magnitude of effect of the text messages, along with qualitative feedback from all 
participants on the logistics, burden, and benefits of such a program. 
 
VII. RISKS AND DISCOMFORTS  
 
A. Complications of procedures 
Participants may be charged for text messages. We will specifically inquire whether participants have a 
text messaging plan on their cellular phone; we will be clear that we are unable to provide any funds to 
cover the costs of text messages and will only enroll those participants who have an unlimited text 
messaging plan on their device to prevent participants from being charged. Regarding physical activity, 
the messages recommend walking as the primary physical activity. It is possible that increasing physical 
activity could have adverse health effects, such as pain, fatigue, or exacerbation of chronic physical 
symptoms. We will clarify with all participants and when requested, their care providers, that increasing 
their physical activity by walking is safe. 
 
B. Drug side effects 
No specific medications are being studied or administered solely for research purposes in this study. 
 
C. Device complications/malfunctions 
No specific devices are being studied or administered solely for research purposes in this study. 
 
D. Psychosocial risks 
Participants may experience discomfort at discussing self-rated psychological experiences and 
their health at the initial and follow-up assessments and could experience the evaluation as intrusive. 
Likewise, though the follow-up assessments (including interview at 4 weeks) should be less than 30 
minutes, participants may experience this long or inconvenient, and we will check in with them about 

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this during the assessment.  We can break up the assessment into shorter parts (quantitative assessment, 
qualitative interview) as needed. The text messages (one/day x 4 weeks) may also be experienced as 
intrusive. We will let patients know at the outset of the interviews that they can ask to stop receiving 
them at any time via text or phone call. 
Participants who do not find the study to provide a benefit to them may find this upsetting as 
well. Activities to obtain data through the follow-up assessments may be inconvenient for subjects. We 
will take all measures to ensure patient comfort and will postpone or end interviews at subjects’ request. 
We will also ensure that the PI or other psychiatrist study staff is available to intervene if needed (due to 
patient discomfort or to answer specific questions about the study), during in-hospital and phone 
assessments. We have used the briefest methods necessary to assess emotional states and other outcomes 
to reduce patient discomfort. 
As with any study, there is the risk of a breach of confidentiality; these risks will be minimized 
by using subject numbers rather than identifying personal data on study documents, and by using locked 
cabinets/offices and password-protected databases to store personal information. Only study staff (the PI 
and the research assistants doing follow-up assessments; in some cases this may also include the study 
cardiologist if there is a question of patient safety or accuracy of ACS diagnosis) will have any access to 
personally identifiable information about subjects, and such access will be limited only to information 
necessary to complete study tasks. We will repeatedly confirm participants’ cellular phone number prior 
to initiating the text messages and will send a generic text message to participants and receive 
confirmation of receipt from them in real time before proceeding with any of the study text messages. In 
addition, the text messages will only contain participants’ first names as entered by them. Regarding 
follow-up assessments and interviews, the digitally audiotaped recordings of the interviews will be 
identified only with a number (with this number linked to identifying information that is kept in a 
password-protected database), will be kept in a password-protected database, and will be destroyed once 
the time period for keeping research-related data has passed. Study staff have been trained in the 
importance of data confidentiality and proper methods of maintaining privacy and confidentiality. 
The main psychosocial safety concern related to patients in this study is regarding depression and 
suicidal ideation, since we will be asking about depressive symptoms via a 0-10 scale. If patients report 
a depression score of 8 or higher at either of the follow-up assessments, they will be asked a series of 
questions about suicidal ideation (see suicidal ideation script). If patients (either enrolled or not enrolled 
in the study) express suicidal ideation, the study psychiatrist will perform a specific evaluation regarding 
suicidality and will arrange urgent assessment and management as needed (e.g., arranging for a patient 
to be seen immediately for a safety assessment in an emergency department). These 
protections/responses have been used as part of several of our team’s projects in the past (e.g., 
2010P001414, 2014P001756), and while we expect it to be very unlikely that a participant will have 
active suicidal ideation, we have successfully activated this protocol and arranged for urgent assessment 
for projects in the past.  
 
E. Radiation risks 
 
There will be no radiation exposure in this study. 
 
VI. 
POTENTIAL BENEFITS 
 
A. Potential Benefits to Participating Individuals 

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Participating individuals may not benefit from participation in this study. Participants receiving 
the text messages may experience improvements in their psychological well-being, motivation to be 
active, amount of physical activity, and/or self-rated health. This may be an improvement over no 
prompts to improve mood and activity, as is current standard practice. Furthermore, the serial 
evaluations will allow access to emergent care if required.  
 
B. Potential Benefits to Society 
 
Increasing positive psychological states in cardiac patients may have important public health 
benefits. Optimism and other positive affective states are prospectively associated with increased 
physical activity and with superior cardiac outcomes. In addition, communications directly promoting 
physical activity have likewise been linked with greater activity and improvement in cardiac risk factors. 
Text messaging is being increasingly investigated as a simple, relatively non-intrusive means of 
providing support, education, and health promotion. This study, by examining the feasibility and 
preliminary impact of text messages focused on well-being and activity promotion, may serve as the first 
step in developing a program in ACS patients. Enhancing activity in this population could in turn result 
in decreased morbidity and mortality. If the text messaging program in this and future studies proves to 
be feasible, well-accepted, and associated with improvements in physical activity and other key 
outcomes, it may be well be possible to utilize these easily-delivered messages as part of a clinical care 
package for ACS patients. Thus participation in this study may result in substantial benefit to future 
patients. 
 
VIII.  MONITORING AND QUALITY ASSURANCE 
 
A. Independent monitoring of source data 
All source data (e.g., chart review data and subject self-report) will be entered into the REDCap 
database. At intervals throughout the study, the PI (Dr. Huffman) will review this data to ensure that it is 
being entered correctly and will perform ‘test downloads’ of the data to ensure that it can be captured in 
the statistical package to be used in this study.  
B. Safety monitoring  
 
The research team will meet on a weekly basis to review study progress. During these weekly 
meetings, the principal investigator will review informed consent documents, study forms, and 
procedures completed that week. The study team will also discuss any procedural difficulties, 
recruitment issues, and adverse events at this meeting (and before if needed). If there are consistent 
issues with the logistics, feasibility, or acceptability of the text messages (e.g., difficulty sending the 
messages, participant complaints about intrusiveness of daily messages), we will review our methods 
and alter the study protocol as needed.  
 
C. Outcomes monitoring 
For this exploratory study, we will not plan to perform interim analyses. However, given the 
feasibility and acceptability focus of this study, we will review ratings of intervention ease/utility and 
pre-post changes in outcomes after 10 and/or 20 participants if our weekly team meeting reviews 
suggest that there are substantial barriers to acceptability (e.g., reports from participants at follow-
ups/interviews, high rates of dropout, requests to stop text messages), in addition to strongly considering 
changes in the protocol as outlined above in Safety Monitoring, above.  
 
 D. Adverse event reporting guidelines 

Piloting text messages to promote positive affect and physical activity—April 16, 2019 
 
12 
 
We will follow all PHRC guidelines with respect to reporting unanticipated problems, including 
adverse events. Specifically, when a serious or nonserious adverse event occurs, the PI will review the 
event to determine if it was possibly or definitely related to participation in the research. For all 
unanticipated problems and adverse events deemed related or possibly related to the research, we will 
complete and submit an Other Event report through Insight/eIRB as soon as possible and within 5 
working days / 7 calendar days (as defined in the March 2014 Reporting Unanticipated Problems 
Including Adverse Events report). At Continuing Review, we will provide a summary of all 
unanticipated problems as per PHRC protocol. Finally, if there are unanticipated problems, especially if 
serious or recurrent, the PI (Dr. Huffman) will amend the protocol if it is deemed necessary to protect 
the safety and welfare of the participants.  
 
-------------- 
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