Researching Emotions And Cardiac Health: Phase III

The investigators are proposing a study that will focus on the implementation of a novel
PP-based health behavior intervention that is adapted for patients with HF. The MGH inpatient
units, MGH Heart Center, and MGH primary care clinic outpatients will serve as the source of
participants for the study, with patients who have a diagnosis of HF serving as potential
participants. The investigators will enroll 60 HF patients, who will take part in a 12-week
PP-based health behavior intervention.

In this project, the investigators hope to do the following:

1. Test a 12-week, telephone-delivered health behavior intervention utilizing PP exercises
and systematic goal-setting in a three-arm, randomized, controlled pilot trial in
patients with mild to moderate HF (N=60).

2. Determine whether this optimized intervention is feasible in a small cohort of HF
patients.

3. Explore potential benefits of the intervention on outcomes of interest (e.g.,
psychological health, functioning, and health behavior adherence) compared to a
motivational interviewing- (MI) based education condition and treatment as usual (TAU).

Baseline information about enrolled participants will be obtained from the patients, care
providers, and the electronic medical record as required for characterization of our
population. This information will include data regarding medical history (history of prior
acute coronary syndrome, coronary artery disease, coronary artery bypass graft, congestive
HF, hypertension, diabetes mellitus, hyperlipidemia, and current smoking), current medical
variables (renal function, left ventricular ejection fraction, NYHA class), medications, and
sociodemographic data (age, gender, race/ethnicity, living alone).

Participants will undergo two in person visits during which they will meet with study staff
in person (or if preferred over the phone). In their first visit, they will answer
questionnaires related to psychological and physical health and functioning and will be asked
to wear an accelerometer for one week to measure their baseline physical activity. At their
second in-person visit, they will be randomized to receive (1) the PP-based health behavior
intervention, (2) the MI-based educational condition, or (3) TAU. Participants in the TAU
group will not receive any additional intervention but will complete follow-up phone calls at
12 and 24 weeks.

Following randomization, participants in the two treatment groups will be provided a
treatment manual corresponding with their treatment condition with weekly exercises, along
with a copy of the Learning to Live with Heart Failure guide. The appropriate intervention
will be introduced, and the first exercise will be assigned. Finally, participants in both
treatment groups will receive a personal step counter to use over the course of the study.

Following the second in-person visit, participants in the PP-based intervention and MI-based
control condition groups will complete twelve 30- to 45-minute weekly phone sessions with a
study trainer. The phone sessions primarily will include a review of the prior week's session
content and a discussion of the rationale and assignment of the next week's
exercise/assignment.

At Weeks 12 and 24, a member of the study staff will call participants to repeat the
self-report questionnaires that were administered at baseline. At these two time points,
participants also will be asked to wear an accelerometer for an additional 7 days to measure
physical activity.

Inclusion Criteria:

- Adult patients with NYHA class I, II, or III HF admitted to an MGH inpatient unit or
outpatients at the MGH Heart Center or MGH-affiliated primary care clinic. Patients
with NYHA class IV HF have ongoing HF symptoms at rest, making it difficult for them
to increase physical activity and other health behaviors; therefore, they will not be
included. HF diagnosis will be confirmed via chart review and with the patient's
treatment team as needed.

- Suboptimal adherence to health behaviors. This will be defined as a total score of ≤15
on three Medical Outcomes Study Specific Adherence Scale (MOS) items regarding
diet/exercise/medications. The MOS has been used in multiple prior studies assessing
adherence in cardiac patients, including our own studies in this population. This
threshold score on the MOS will ensure that all participants will have the potential
to improve their health behaviors.

Exclusion Criteria:

- Cognitive deficits impeding a participant's ability to provide informed consent or
participate, assessed via a 6-item cognitive test that is sensitive and specific for
screening for cognitive impairment in research participants.

- Medical conditions precluding interviews or likely to lead to death within 6 months.

- Inability to speak English, inability to read or write, inability to walk, or lack of
a telephone.