A Randomized Controlled Trial to Reduce Hopelessness Through Enhanced Physical Activity in Adults With Ischemic Heart Disease
Phase: NA
Conditions: Ischemic Heart Disease, Hopelessness, Physical Activity, Motivation, Social Support, Covid19
Sponsor: University of Illinois at Chicago

A Randomized Controlled Trial to Reduce Hopelessness through Enhanced Physical 
Activity in Adults with Ischemic Heart Disease 
 
Study Protocol and Statistical Analysis Plan 
 
NCT03907891 
 
December 14, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Study Protocol  
Recruitment, Consent and Screening. Nurse recruiters, who are employed by the hospital’s 
Research Department and who do not provide direct patient care, will determine eligibility for 
hopelessness screening by reviewing the patient’s medical record. Nurse recruiters will 
approach eligible hospitalized IHD patients and invite them to be screened for potential 
consideration for the study. Recruiters will use a script to introduce the screening portion of the 
study, explaining that eligibility for the RCT will depend on screening results. Interested patients 
will provide written consent for the hopelessness screening, including a HIPAA waiver. The 
consent will include permission for review of the patient’s medical records to collect patient 
characteristics. These data can contribute to external validity of the study findings. Patients will 
be screened for hopelessness using the 10-item state subscale of the 23-item State-Trait 
Hopelessness Scale (STHS). Based on cut-point criteria in our earlier research, a criterion of 
≥1.8 will be used for classification of moderate to severe hopelessness levels. Patients who do 
not meet the hopelessness criteria will be thanked for their participation.  
We will enroll both women and men. Our recent pilot enrolled 30 participants and 9 were female 
(30%), which is typical for the IHD population. We expect to experience enrollment and retention 
of women at a rate equal to our pilot work, since we are using the same recruitment strategies. 
We will recruit patients of all races and ethnicities. Our recent pilot enrolled 30 participants and 
3 were racial/ethnic minority (10%). However, we expect our sample to be representative of the 
hospital’s catchment area (different from the pilot study hospital), which has 15% racial minority. 
If needed, we will oversample for women and minorities to enroll a heterogeneous sample 
congruent with the American population. We will ensure the recruitment of women and racial 
minorities by training the nurse recruiters and other staff. 
Study Consent and Randomization. For patients who meet hopelessness screening criteria 
and wish to participate, the recruiters will read through a script to describe the RCT. Recruiters 
will explain that if a patient enrolls, there is a 33% chance of being in one of the three groups 
(MSS, MSS with SOS, or AC). Patients will be informed that if they are randomized to the MSS 
with SOS group, they will be asked to identify a significant other to provide support as part of the 
study. If the patient agrees to enrollment in the study, written consent will be obtained and the 
patient will be immediately randomized using a randomization scheme loaded into the UIC 
Biomedical Research Informatics Core’s (BRIC’s) Research Electronic Data Capture (REDCap) 
system. Patients in the MSS with SOS group will then be asked to select a family member or 
friend to serve as their support person. The nurse recruiter will meet with the significant other in 
the hospital, if available, or collect the contact information for the significant other from the 
patient and contact the significant other by phone. The nurse recruiter will explain the study to 
the significant other and the role that s/he would play in sending text messages (developed by 
the researchers) to the patient. If the significant other agrees, the nurse will either provide the 
consent form to the significant other during the patient’s hospitalization or mail a consent form to 
the significant other and provide a postage-paid envelope for its return. The timing of the text 

messages coincides with the typical 6 to 8 week recovery period for patients who have 
experienced MI or CABG, a time when family members and friends wish to be helpful. All 
(100%) of the patient’s significant others invited to participate in our pilot RCT were willing to do 
so. However, in the proposed full RCT, if a significant other does not wish to participate, the 
patient will be asked to select a different significant other and that person will be contacted.  
Data Collection. Data collection for all three groups will occur in the patient’s home at 3 time 
points over the 24-week period and will include accelerometer monitoring for 1 week prior to 
each of the data collection visits. There will be one accelerometer placement visit in the patient’s 
home at baseline (within 1 week of hospital discharge). At the one-time accelerometer visit, the 
data collector will instruct the patient on the use of the accelerometer and PA log, place the 
monitor on the patient, and activate it. This visit will take approximately 15 minutes. The patient 
will be asked to wear the accelerometer and complete the PA log for 1 week. The data collector 
will return after the week to retrieve the accelerometer and to conduct baseline data collection. 
At weeks 7 and 23, the accelerometer will be shipped to the patient with instructions to wear it 
again for 1 week. At weeks 8 and 24, data collectors will return to the patient’s home to retrieve 
the accelerometer and to conduct data collection. All data collection interviews will take on 
average 30 minutes. If a patient becomes fatigued during any home visits, s/he will be allowed 
to rest or the study staff will return the following day to complete the session. All patients in our 
preliminary study completed each of the accelerometer visits and data collection interviews in 
one sitting and none complained of fatigue. Medical record data will be collected after the 
patient’s hospital discharge.  
Description of the Intervention. Intervention components include a 60-minute motivational 
interviewing session with a nurse and text messages (developed by researchers) sent from the 
nurse for the MSS and MSS with SOS groups. Patients in the MSS with SOS group will also 
receive text messages (developed by researchers) sent by the significant other. The AC group 
will receive 60 minutes of AHA videos with instruction on taking their radial pulse (details below). 
Intervention components for the 3 groups include: 
Group 1: MSS. Patients will receive a 60-minute session of motivational interviewing in their 
home from a trained nurse. Motivational interviewing, a directive, client-centered counseling 
style for eliciting behavior change by helping clients to explore and resolve ambivalence, has 
been effective in increasing PA in patients with multiple sclerosis, stroke, and IHD. The nurse 
will apply motivational interviewing techniques to explore the patient’s thoughts about making a 
behavior change to attain adequate PA. The session will include the patient’s thoughts about PA, 
types of PA available, barriers to PA, the benefits of PA, and setting PA goals. Because of a 
hopeless patient’s negative and helpless outlook on the future, the motivational interviewing 
sessions will be tailored with an increased emphasis on the benefits of PA, overcoming barriers 
to PA, and the patient’s confidence level in achieving PA. Two motivational interviewing tools 
(measured on a Likert-type scale) will be used to help patients think about PA in a concrete 
manner: 1) an “Importance of PA” ruler and 2) a “Confidence with PA” ruler. Patients will be 
encouraged to exercise based on instructions provided by the hospital staff. The nurse will 
provide a written copy of the hospital PA instructions and a PA log. The patient’s ability to take 
their radial pulse before and after PA will be assessed, and patients will be provided written 

instructions on the correct manner to take a radial pulse. Patients will be provided with 3 
motivational magnets with the Heart Up! logo to be used for displaying the PA log and rulers.  
After the motivational interviewing is complete, the nurse will inform the patient of the start date 
of the nurse’s text messages. Patients will receive daily motivational text messages from the 
nurse for 6 weeks. The 42 text messages were developed by the research team based on Self-
Determination Theory and Cohen’s Stress and Coping Social Support Theory. As in our 
preliminary work, the texts will be sent via the REDCap automated system. The order of texts 
will be randomized so that the order is unique to each patient, allowing for us to determine if the 
text messages are effective in general (versus the order that that messages are given). Based 
on preferences expressed by patients in our earlier work, texts will also be randomized to arrive 
within a 2-hour time frame from 10:00 am to 12:00 noon. The automated system confirms that 
texts were sent. The motivational interviewer nurse will confirm by phone that the patient 
receives her/his first text from the REDCap system. Although REDCap cannot track whether 
texts were opened/read, patients will be asked to track the number of text messages from the 
nurse that they read over the 6-week period using a log provided by the nurse. 
Group 2: MSS with SOS. Patients will also receive a 60-minute session of motivational 
interviewing in their home from a trained nurse and text messages from a nurse for 6 weeks, as 
described above. In addition, patients will receive daily text messages from their significant 
other for 6 weeks. It is hypothesized that the Heart Up! intervention’s integration of social 
support within the patient’s existing social network (the patient’s self-identified significant other) 
will be a critical component and provide the greatest impact in increasing PA in hopeless 
patients. Researchers developed the 42 significant other text messages based on Self-
Determination Theory and Cohen’s Stress and Coping Social Support Theory. The motivational 
interviewing nurse will provide the text messages to the significant other in writing (mailed with 
the consent). The order of texts sent from the significant other will be randomized so that we 
can determine their effectiveness in general. The significant other will be asked to type and send 
the text message listed for each date to both the patient and to the REDCap system (for 
verification that the message was sent). Based on feedback received from patients in our pilot 
study, and to avoid text messages being sent at the same time as the nurse text messages, 
significant others will be asked to send their text messages between the hours of 1:00 pm to 
3:00 pm and to vary the times sent from day to day. If the REDCap system does not receive a 
copied text from the significant other by 3:00 pm, it will send a reminder to the significant other. 
The motivational interviewer will confirm by phone that the patient received the first text from the 
significant other. Patients will be asked to track the number of text messages from the significant 
other that they read over the 6-week period using the log provided. Our dyadic approach is 
distinctive in combining these two components (motivational interviewing and text messaging) 
by the nurse with the additional unique component of an emotional support text messages from 
the patient’s significant other, for use exclusively with hopeless IHD patients. Because the Heart 
Up! intervention includes only 1 motivational interviewing session (followed by text messages by 
a nurse and significant other), Heart Up! has good potential to be translated into practice with 
hopeless IHD patients in an efficient and practical way.  

Group 3: AC. Patients in the AC group will receive a 60-minutes session with a research 
assistant focused on the viewing of AHA “About Conditions” and “Tips for Healthy Living” 
YouTube videos. The research assistant will additionally provide a written copy of the hospital 
PA instructions, will assess the patient’s ability to take their pulse, and provide written 
instructions on the correct manner to take a radial pulse.  
Patients in all 3 groups will have interaction with data collectors in their home for the first 
accelerometer placement and 3 data collection visits. The motivational interviewer or data 
collector (for the AC group) will ask permission of patients to audiotape the motivational 
interviewing or AHA video session for quality assurance purposes. 
Treatment Fidelity. Treatment fidelity will be assured through established methods outlined by 
the Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. A treatment fidelity 
plan was developed by the PI as part of the preliminary study and will be carried out in the 
proposed RCT by the project manager, in collaboration with the PI. The plan incorporates the 
workgroup’s 5 recommended components: study design, training, treatment delivery, treatment 
receipt, and treatment enactment. Every 3 months, 15% of the audiotaped motivational 
interviewing sessions will be randomly selected for QA review. Tools completed by patients as 
part of the intervention (i.e. rulers, PA log, and text messaging log) will undergo QA review for 
completeness and accuracy. 
Incentives. To compensate patients for the time taken and any inconvenience for home visits 
and accelerometer monitoring over the 6-month study period, we will compensate $20 for 
completion of the baseline data collection, $30 after week 8, and $50 after week 24 (total $100). 
At study completion, all patients will receive a thank you letter and patients in the AC group will 
receive the Heart Up! motivational magnets (given previously to patients in the MSS and MSS 
with SOS groups).  
Attrition. The data collectors and motivational interviewers will document attrition, including 
dates and reasons, during reminder telephone calls with patients, calls to significant others, and 
visits to patients. Recruiters, data collectors, and motivational interviewers will emphasize the 
importance of completing the intervention, wearing the accelerometer, and completing the 3 
data collection sessions. Patients will be scheduled for their first home visit and provided an 
appointment card for this visit prior to hospital discharge. Patients will also receive reminder 
phone calls for all appointments. The motivational interviewer will call the patient and significant 
other (if appropriate) to confirm that text messages are being sent and received. Patients will be 
provided adequate time for discussion and to have their questions answered. Study participants 
will be provided with a toll-free number to call the study office with any questions. These 
strategies were effective in our pilot study, in which 67% of patients and 100% of significant 
others completed the study.19  
Statistical Analysis Plan 
Data Management. Data will be stored on a secure dedicated server with appropriate firewalls 
using the UIC REDCap system (see Data and Safety Monitoring Plan). Data will be entered into 
the REDCap database via Web interface. The web server synchronizes uploaded files to an 
alternate location and is backed up daily. De-identified data sets for analyses will be created by 

importing data from REDCap into the statistical program R. Quarterly QA reports will be 
reviewed by a Data and Safety Monitoring Committee.  
Plan for Statistical Analyses. The rigor of the study design will produce objective, unbiased, 
and interpretable results. Data analysis and hypothesis testing will proceed in several steps: 1) 
description of the sample overall and across the 3 treatment groups, as well as patients lost to 
attrition; 2) confirmation of internal reliability of scales; and 3) bivariate and multivariate analysis 
of the interrelationships between treatment groups for PA and state hopelessness. 
Analysis plan for Aim 1 and 2. Aim 1: Test the effectiveness of 6 weeks of MSS and MSS with 
SOS on increasing mean minutes per day of moderate to vigorous PA, measured by an 
ActiGraph accelerometer and Aim 2: Determine the effects of change in minutes per day of 
moderate to vigorous PA on state hopelessness, measured by the State-Trait Hopelessness 
Scale (STHS). Initial bivariate analyses for Aims 1 and 2 will be conducted using ANOVA or 
simple linear models using R, testing for changes in minutes of moderate to vigorous PA (Aim 1) 
or association between change in exercise and changes in state hopelessness (Aim 2) between 
baseline and week 8 or baseline and week 24 by treatment group. We will also use linear mixed 
effects models (lme4 function in R) to incorporate multiple waves of data from each participant, 
covariates, and mediators into the analysis (Aims 1, 2 and 3), following the general approach we 
have used before. In particular, we will simultaneously model data across the two post-baseline 
time points and account for within- and between-subject effects and time-independent and time-
dependent predictors. For Aim 1, we will predict minutes of moderate to vigorous PA by 
treatment group, adjusting for covariates and baseline activity level. Aim 2 follows an approach 
similar to Aim 1, and predicts state hopelessness levels by changes in exercise, adjusting for 
covariates and baseline state hopelessness levels. 
Analysis plan for Aim 3. Aim 3: Determine if social support (measured by the ENRICHD Social 
Support Inventory) and motivation (measured by the Exercise Self-Regulation Questionnaire) 
mediate effects of the Heart Up! intervention on PA. For Aim 3, models for Aims 1 and 2 will be 
expanded by also including one or more mediating variables, including prior measurements of 
state hopelessness and moderate to vigorous PA, using the three-step approach of Barron and 
Kenney: 1) Confirm relationship between treatment and social support or motivation using a 
linear mixed model, 2) Confirm relationship between treatment and changes in exercise (Aim 1), 
and 3) Predict changes in exercise by both treatment and social support (or motivation) 
demonstrating that social support and/or motivation explain most of the changes in exercise as 
compared to treatment. Models will include covariates as in Aims 1 and 2 and include multiple 
waves of data. We will use a modified Bonferroni approach to control for Type I errors when 
testing multiple mediators simultaneously. 
Subgroup analyses (e.g. sex- see section 3C.20) will be conducted by estimating main effects of 
treatment groups or mediating variables on the response within each subgroup, and testing for 
potential differential effects between subgroups by incorporating relevant interaction terms into 
the models.