Trajectory of Positive Psychological States in Patients With ACS

Acute Coronary Syndrome Clinical Trial

— PEACEIIa  

Official title:

Trajectory of Positive Psychological States in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298296
• Other study ID #: 2014P000945
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: April 18, 2016
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in positive affect measured by self-report questionnaires	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]).	Baseline, 8 weeks	No
Secondary	Change in behavior adherence measured by a self-report questionnaire	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).	Baseline, 8 weeks	No
Secondary	Change in function measured by self-report questionnaires	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]).	Baseline, 8 weeks	No