Trajectory of Positive Psychological States in Patients With ACS

Trajectory of Positive Psychological States in Patients With Acute Coronary Syndrome

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02298296

Acronym

PEACEIIa

Enrollment

Registered

2014-11-21

Start date

2014-06-30

Completion date

2014-12-31

Last updated

2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Brief summary

The purpose of the study is to to determine the natural history of positive psychological states, health status, and functioning, over an 8 week period following admission for an acute coronary syndrome (ACS). We aim to compare the changes in these factors from baseline to 8-week follow-up with corresponding changes in the completed proof-of-concept intervention trial (NCT02004158).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Suboptimal adherence to health behaviors. This will be defined as mean item score of \<15 (suboptimal) on three Medical Outcomes Study-Specific Adherence Scale (MOS SAS) items. * Submaximal self-reported optimism. This will be defined as a total score of \<30 on the Life Orientation Test-Revised (LOT-R) . * Submaximal self-reported positive affect. This will be defined as a total score of \<50 on the Positive and Negative Affect Schedule (PANAS) .

Exclusion criteria

* Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies. * Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator Dr. Januzzi. * Inability to communicate in English. * Inability to participate in physical activity.

Design outcomes

Primary

Measure	Time frame	Description
Change in positive affect measured by self-report questionnaires	Baseline, 8 weeks	To determine the change in positive psychological states, specifically optimism and positive affect, over an 8 week period following admission for ACS as measured by the Life Orientation Questionnaire (LOT-R \[trait optimism\]), Life Orientation Questionnaire-State (LOT-RS \[state optimism\]), and the Positive and Negative Affect Schedule (PANAS \[positive affect\]).

Secondary

Measure	Time frame	Description
Change in behavior adherence measured by a self-report questionnaire	Baseline, 8 weeks	To assess changes in health behavior adherence over an 8 week period following admission for ACS using the Medical Outcomes Study-Specific Adherence Scale (MOS-SAS items on physical activity, diet, and medication).
Change in function measured by self-report questionnaires	Baseline, 8 weeks	To assess changes in functional status over an 8 week period following admission for ACS using the Women's Ischemia Syndrome Evaluation (WISE \[functional status\]) and the Short Form health survey (SF-12 \[health-related quality of life\]).

Outcome results