Researching Emotions And Cardiac Health (REACH): Phase II
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/18/2018 |
| Start Date: | December 6, 2016 |
| End Date: | August 10, 2017 |
Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: proof-of Concept Trial
The focus of this study is to examine the feasibility, acceptability, and preliminary impact
of our customized positive psychology (PP)-based health behavior intervention in a group of
patients with mild to moderate heart failure (HF).
of our customized positive psychology (PP)-based health behavior intervention in a group of
patients with mild to moderate heart failure (HF).
The investigators are proposing a study that will specifically and innovatively focus on the
development of a novel positive psychology intervention that is adapted for patients with HF.
The MGH inpatient units and MGH Heart Center outpatients will serve as the source of subjects
for the study, with patients who have a diagnosis of HF serving as potential subjects. The
investigators will enroll 10 HF patients, who will take part in an 10-week PP-based health
behavior intervention.
In this project, the investigators hope to do the following:
1. Test an 10-week, telephone-delivered health behavior intervention utilizing PP exercises
and systematic goal-setting in a brief, non-randomized, proof-of-concept trial (N=10).
2. Determine whether this initial intervention is feasible in a small cohort of HF
patients.
3. Explore potential benefits of the intervention on outcomes of interest (e.g., optimism,
positive affect).
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 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 under go an initial visit during which they will meet with study staff in
person (or if preferred over the phone).
• They will fill out baseline questionnaires, and be provided a treatment manual with weekly
exercises, along with a copy of Learning to Live with Heart Failure. The PP and goal-setting
portions of the intervention will be introduced, and the first exercise will be assigned.
Finally, participants will be provided an ActiGraph accelerometer to wear for 7 days, as well
as a personal step counter to keep.
Participants will undergo weekly phone sessions for 10 weeks.
- For the positive psychology segment the participant will review the previous week's
exercise, discuss of the rationale of the next week's exercise, and be assigned the next
week's exercise.
- For the goal-setting segment the participant will review the health goal from the prior
week, receive education about a health behavior, discuss ways to improve health
behaviors, and set a goal for the next week.
Participants will undergo a follow-up phone call at 10 weeks that asks the same questions
that were answered during the initial visit, as well as questions about their experience
using the ActiGraph.
• At Week 10, participants will wear another ActiGraph for 7 days.
development of a novel positive psychology intervention that is adapted for patients with HF.
The MGH inpatient units and MGH Heart Center outpatients will serve as the source of subjects
for the study, with patients who have a diagnosis of HF serving as potential subjects. The
investigators will enroll 10 HF patients, who will take part in an 10-week PP-based health
behavior intervention.
In this project, the investigators hope to do the following:
1. Test an 10-week, telephone-delivered health behavior intervention utilizing PP exercises
and systematic goal-setting in a brief, non-randomized, proof-of-concept trial (N=10).
2. Determine whether this initial intervention is feasible in a small cohort of HF
patients.
3. Explore potential benefits of the intervention on outcomes of interest (e.g., optimism,
positive affect).
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 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 under go an initial visit during which they will meet with study staff in
person (or if preferred over the phone).
• They will fill out baseline questionnaires, and be provided a treatment manual with weekly
exercises, along with a copy of Learning to Live with Heart Failure. The PP and goal-setting
portions of the intervention will be introduced, and the first exercise will be assigned.
Finally, participants will be provided an ActiGraph accelerometer to wear for 7 days, as well
as a personal step counter to keep.
Participants will undergo weekly phone sessions for 10 weeks.
- For the positive psychology segment the participant will review the previous week's
exercise, discuss of the rationale of the next week's exercise, and be assigned the next
week's exercise.
- For the goal-setting segment the participant will review the health goal from the prior
week, receive education about a health behavior, discuss ways to improve health
behaviors, and set a goal for the next week.
Participants will undergo a follow-up phone call at 10 weeks that asks the same questions
that were answered during the initial visit, as well as questions about their experience
using the ActiGraph.
• At Week 10, participants will wear another ActiGraph for 7 days.
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. 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 SAS) items regarding
diet/exercise/medications. The MOS SAS 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 SAS 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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-6485
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