Pilot Randomized Controlled Trial of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure
Phase: NA
Conditions: Heart Failure
Sponsor: The Miriam Hospital

 
STUDY PROTOCOL 
 
Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults 
With Heart Failure 
 
NCT05575375 
 
1/16/2023 
 
 

VALUES-AFFIRMATION INTERVENTION TARGETING MEDICATION 
ADHERENCE IN OLDER ADULTS WITH HEART FAILURE 
Principal Investigator: Emily C. Gathright, PhD 
Supported by: 
The National Institute on Aging 
K23AG061214 
 
 

1 
STUDY DESIGN 
This research will examine the initial feasibility and acceptability of a values-affirmation, 
education, and skills-training intervention targeting heart failure (HF) medication adherence 
using the NIH Stage Model for Behavioral Intervention Development (Onken et al., 2014).  
Design: This study is a Stage 1B trial and will use a randomized controlled trial design. 
Participants will be randomized 1:1 basis to the Values-affirmation Intervention condition (n = 
25) or Usual Care (n = 25).  
Setting: Study assessments and intervention delivery will occur either at the participant’s home 
or The Miriam Hospital’s Center for Behavioral and Preventive Medicine (CBPM). The location 
will be determined by participant preference. Data management and analysis will be housed at 
CBPM.  
Study Duration: Study duration is estimated to be 21-24 months from the time of enrollment of 
the first subject to completion of data collection. Individual participants will complete the 
protocol within 8-10 weeks from the time of the baseline visit until the end-of-treatment 
assessment. Study completion is defined as completion of the baseline and end-of-treatment 
assessments, intervention content, and medication monitoring period.  
 
Sample: 50 older adults with HF, ages 50 and older, who are enrolled in a CR program in 
Providence, Rhode Island will be recruited. We aim to recruit a sample that is 51% women and 
30% individuals who identify as a NIH-defined racial or ethnic minority.  
 
2 
PRIMARY OBJECTIVE 
The primary objectives of this study are to assess randomized controlled trial feasibility and 
acceptability through a randomized controlled pilot trial. Primary endpoints are feasibility of 
study procedures (e.g., monthly recruitment rates, percent of enrolled participants who complete 
the study), and acceptability (e.g., self-reported patient acceptability questionnaire). We 
hypothesize that the study and intervention will be 1) feasible, and 2) acceptable. 
 
3 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
3.1 Inclusion Criteria  
Older adults with a diagnosis of HF upon admission and other CR participants with a HF 
diagnosis regardless of CR referral reason will be eligible for inclusion (e.g., an individual 
referred for CR following a myocardial infarction who also has a HF diagnosis will be invited to 
participate).  
Additional inclusion criteria will include: (1) adults ≥ the age of 50 at the time of study initiation 
and (2) English-speaking. 
3.2 Exclusion Criteria  
(1) current participation in a medication-monitoring clinical or research protocol, (2) severe 
cognitive impairment on cognitive screening measures or diagnosis of Alzheimer’s or dementia, 
(3) current suicidality, (4) acute psychosis, (5) chart documentation of NYHA-class IV HF, or 

(6) patient report that someone other than the patient is primarily responsible for the patient's 
medication management and medication-taking.   
3.3 Study Enrollment Procedures  
Recruitment  
Participants will be recruited from the Cardiac Rehabilitation Center at the Miriam Hospital 
(Providence, RI) and Lifespan Cardiovascular Institute, Lifespan Ambulatory Care Center 
(East Greenwich, RI). Patients deemed to meet initial inclusion criteria (i.e., HF diagnosis, 
aged ≥50 years, no chart documentation of severe cognitive impairment or dementia, 
English-speaking) based on chart review will either be approached in the clinic or will be 
mailed a letter invitation to participate and contacted via phone one week later. Individuals 
who are approached in clinic will be asked to complete a “Consent to Contact” form. If 
patients do not respond to two telephone calls, they will not be telephoned again.  
 
Screening 
Patients will be asked to complete eligibility screening via telephone. They will also be 
asked to complete the Blessed Orientation Memory Concentration test (BOMC) to screen 
for significant cognitive impairment. Participants who score 10 or greater on the BOMC will 
not be eligible.  
4 
ASSESSMENT PROCEDURES  
4.1.1 Baseline Assessments (Visit 1) 
• Demographics (self-reported) and medical comorbidity (supplemented via medical chart 
review).  
• The Medication Management Instrument for Deficiencies in the Elderly will assess 
individual patient knowledge of their specific medication instructions.  
• Timeline follow-back medication adherence interview. Participants will be prompted to 
recall missed or late medications for each day in backwards order during the preceding 7 
days. 
• Pill Count of 1 medication: We will conduct a pill count of ONE medication per patient 
using the criteria adopted by Wu et al.  
• Medication Adherence Scale.  
• LifeWindows Information--Motivation--Behavioral Skills ART Adherence Questionnaire 
was adapted for use in HF to assess HF medication knowledge, related motivation, and 
behavioral skills in line with the sIMB-CIM model.  
• The Rapid Estimate of Adult Literacy in Medicine—Short Form will assess health 
literacy.  
• Valued Living Questionnaire 
• Free, cued, and delayed recall will be measured using the Memory Impairment Screen-
Delayed.   
• Patient Health Questionnaire 9 
• Positive and Negative Affect Scale-Short Form 
• Perceived Stress Scale-Short Form 
• ENRICHD Social Support questionnaire 
• Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy 

for Managing Chronic Conditions- Managing Medications and Treatment- Short Form 4a 
• the Minnesota Living with Heart Failure Questionnaire (MLHFQ) 
• EuroQual-5 Dimension (EQ-5D) 
 
• Monitored Medication Adherence 
Participants will also be asked to use a MEMS cap pill bottle to monitor medications for 
approximately 8 weeks (from the baseline assessment through the end-of-treatment 
assessment). We will monitor ONE medication per patient using the criteria adopted by Wu 
et al. Briefly, if the patient takes any HF medication twice a day, this medication will be 
MEMS-monitored. If all HF medications have the same daily prescription schedule, the β-
blocker will be monitored. If the patient does not receive a β-blocker, the ACE inhibitor or 
the angiotensin receptor blocker will be used instead. If none of these drugs is prescribed, the 
aldosterone antagonist or statin, or digoxin or diuretic will be monitored. Participants will 
receive a MEMS bottle at the baseline visit and will be instructed to open it only when they 
actually take their medication; they will also be trained to keep track of unscheduled lid 
openings (i.e. refills, accidental openings) in a diary; these events will be removed prior to 
analysis. After the baseline visit, participants will enter a 30-day run-in for the assessment of 
baseline adherence. Participants will start using the cap on the day following the baseline 
visit (=time 0), and the intervention will start 30 days later; this 30-day period will be 
considered our baseline.  
MEMs Caps are designed to be easily opened and closed, and to be very similar in 
design to pill bottles commonly used commercially. Participants will be asked to review their 
medication regimen with PI/SRA. Participants will be asked to fill the bottle with their 
prescribed heart medication selected for monitoring Prior to use, a study team member will 
demonstrate appropriate use of the pill bottle and will invite participates to practice opening 
and closing the containers.  
 
Written instructions will be provided to all participants, including study staff contact 
information. Participants will be encouraged to contact staff in the event of any questions or 
concerns. One week following the baseline assessment and initiation of monitoring, study 
staff will call the participant to ask if there are any questions regarding use of the devices. 
Any emergent questions will be answered.  
 
  
4.1.2 Intervention Session + Pill Count Check OR Pill Count Check only (Visit 2) 
• Following completion of the Baseline monitoring period, study staff will contact the 
participant and inform the participant of their randomization assignment via telephone, 
and schedule Visit 2. Visit 2 will be conducted either at the participant’s home or the 
study office, as determined by participant preference. Individuals assigned to the 
Intervention condition will also complete the intervention at this session (see details in 
Section 6). For participants in both conditions, we will again conduct a pill count of ONE 
medication per patient using the criteria adopted by Wu et al. described above. 
4.1.3 Final Evaluation (Visit 3) 
o 7-day Timeline follow-back procedure to assess self-reported medication 
adherence. 
o Medication Adherence Scale  

o Pill Count of 1 medication 
o Valued Living Questionnaire 
o Patient Health Questionnaire 9 
o Positive and Negative Affect Scale- Short Form 
o Perceived Stress Scale- Short Form.  
o ENRICHD Social Support questionnaire 
o Patient-Reported Outcomes Measurement Information System: Patient-Reported 
Outcomes Measurement Information System (PROMIS) Self-Efficacy for 
Managing Chronic Conditions- Managing Medications and Treatment- Short 
Form 4a 
o Minnesota Living with Heart Failure Questionnaire (MLHFQ) 
o EuroQual-5 Dimension (EQ-5D) 
o Study and Treatment Acceptability.  Participants will complete a self-report 
measure which gathers feedback about the study. 
 
4.2 Interventions, Administration, and Duration  
Following completion of the baseline adherence monitoring period, participants will be randomly 
assigned to one of two conditions. Participants will be scheduled for Visit 2 at the end of the 
baseline adherence monitoring period. Participants will be randomized and notified of group 
assignment upon arrival to Visit 2. 
Group A (Usual Care): Participants assigned to Group A will receive the standard care that they 
would receive as part of cardiac rehabilitation. 
Group B (Values affirmation intervention condition): Participants assigned to Group B will 
receive standard care in addition to the Values affirmation intervention condition. Participants 
will complete a one intervention session with the study interventionist (about 60 minutes). The 
session will include: 
1. Participation in a values-affirmation exercise (i.e., Values card sort activity).  
2. Working with the interventionist to devise a way to tangibly connect that value with 
medication-taking (i.e., placing a label with a word or picture of the value on a pill bottle 
or display next to the pill bottle). Values labels will be based on images presented on the 
values card sort cards or personalized pictures taken with a Lifespan-issued tablet and 
printed on site with a portable photo printer. Once the picture is printed it will be deleted 
from the tablet.  
3. Provision and review of a patient education workbook that recommendations for skills 
training activities to improve regimen management.  
5 
COMPENSATION 
Participants will be compensated a total of $90 in this research study. Specifically, they will 
receive $30 in cash following Visit 1 and $60 in cash following Visit 3. Participants who prefer 
to attend study visits at the Coro Building will also be given a parking voucher. 
6 
PRIMARY ENDPOINTS 
Primary Endpoints: 

1) Recruitment feasibility will be determined through examination of the percentage of 
eligible patients who enroll in the study.  
2) Study feasibility will be calculated as the percentage of individuals who were enrolled 
and completed both the baseline assessment, intervention (when applicable), monitoring 
period, and end-of-treatment assessment. Feasibility of procedures will be defined as 
achieving a retention rate of 80%. 
3) Patient acceptance of the intervention will be determined by mean satisfaction ratings 
rated on self-report measures with Likert-type questions and assessed through open-
ended responding. Adequate acceptability will be defined as ≥ 80% endorsement of being 
at least somewhat satisfied with participation. 
7 
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