Trajectory of Positive Psychological States in Patients With ACS

NCT02298296 | Completed

• 1 other identifier: 2014P000945
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in behavior adherence measured by a self-report questionnaire

  Baseline, 8 weeks

• Change in function measured by self-report questionnaires

  Baseline, 8 weeks

Study Arms (1)

No treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects were recruited from inpatient cardiac units in a large, urban hospital.

You may qualify if:

• 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) .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jeff C Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 21, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 19, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share